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Emdyca

Instruments for functional explorations and therapeutic interventions

Dental stomatology instruments

EMDN code Z1211

205 manufacturers, 1,720 models including 1,680 on the market, 26 countries

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Manufacturers registered in Europe (EUDAMED) 205
  • On the market
  • No longer marketed
  • 93/42 Former directive, not yet certified under the MDR
  • Click a manufacturer to see its full range, a model to open its EUDAMED record.
ManufacturerCountryRegistered modelsClassContact
Nakanishi FDA EU representative : NSK Europe GmbH (Germany) Japan
197 others
I, IIa MDR, 93/42 Website EUDAMED record Report an error
Diaswiss FDA EU representative : DFS-Diamon GmbH (Germany) Switzerland
150 others
IIa 93/42 Website mail@diaswiss.ch EUDAMED record Report an error
Medigma Biomedical Germany
90 others
I, IIa MDR, 93/42 office@medigma-implants.com EUDAMED record Report an error
Being Foshan Medical Equipment EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
85 others
IIa MDR, 93/42 EUDAMED record Report an error
Medical Consult Implants Germany
67 others
IIa 93/42 Website EUDAMED record Report an error
Modemedikal Türkiye
57 others
IIa 93/42 Website EUDAMED record Report an error
Bioner Spain
45 others
IIa 93/42 Website EUDAMED record Report an error
Evidence Implant FDA EU representative : Meridius Medical Europe Limited (Ireland) South Korea
45 others
IIa 93/42 Website EUDAMED record Report an error
Foshan COXO Medical Instrument FDA EU representative : Lotus NL B.V. (Netherlands) China
31 others
I, IIa MDR, 93/42 EUDAMED record Report an error
Wh FDA Austria
31 others
I, IIa MDR, 93/42 Website RA@wh.com EUDAMED record Report an error
DXL Medical Germany
23 others
IIa 93/42 Website EUDAMED record Report an error
Foshan SOCO Precision Instrument FDA EU representative : Lotus NL B.V. (Netherlands) China
22 others
IIa MDR, 93/42 Website EUDAMED record Report an error
Miglionico Italy
21 others
IIa 93/42 Website info@miglionico.net EUDAMED record Report an error
Paltop Advanced Dental Solutions FDA EU representative : MedNet EC-REP IIb GmbH (Germany) United States
21 others
IIa 93/42 Website customersupport@keystonedental.com EUDAMED record Report an error
A. S. Technology Componentes Especiais LTDA EU representative : Eurofix - Implantes e Componentes Dentários, Lda. (Portugal) Brazil
33 others
IIa 93/42 EUDAMED record Report an error
Cowellmedi FDA EU representative : AR Experts B.V. (Netherlands) South Korea
20 others
IIa MDR Website EUDAMED record Report an error
LM-Instruments FDA Finland
18 others
IIa 93/42 Website info@lm-dental.com EUDAMED record Report an error
Adin Dental Implant Systems FDA EU representative : MedNet EC-REP GmbH (Germany) Israel
16 others
IIa MDR info@adin-implants.com EUDAMED record Report an error
devemed FDA Germany
16 others
IIa 93/42 Website info@devemed.de EUDAMED record Report an error
Scorpion France
16 others
IIa MDR, 93/42 Website contact@scorpion.fr EUDAMED record Report an error
Guilin Woodpecker Medical Instrument FDA EU representative : MedNet EC-REP C IIb GmbH (Germany) and 1 other China
15 others
I, IIa MDR, 93/42 Website sales@glwoodpecker.com EUDAMED record Report an error
NWT Germany
14 others
IIa 93/42 Website info@nwt.care EUDAMED record Report an error
Guilin Refine Medical Instrument FDA EU representative : MedNet EC-REP C IIb GmbH (Germany) China
11 others
I, IIa MDR, 93/42 Website EUDAMED record Report an error
Sifary FDA EU representative : Caretechion GmbH (Germany) China
11 others
IIa MDR, 93/42 Website info@sifary.com EUDAMED record Report an error
Parkell FDA EU representative : Directa AB (Sweden) United States
28 others
I, IIa MDR, 93/42 Website EUDAMED record Report an error
Dental Tech Italy
10 others
IIa 93/42 Website info@dental-tech.it EUDAMED record Report an error
Altatec FDA Germany
9 others
IIa MDR Website raphael.brausch@altatec.de EUDAMED record Report an error
Saeyang FDA EU representative : Marathon Italia S.R.L. (Italy) South Korea
9 others
IIa 93/42 Website EUDAMED record Report an error
Cefla FDA Italy
8 others
I, IIa MDR, 93/42 Website EUDAMED record Report an error
Foshan Gladent Medical Instrument FDA EU representative : Lotus NL B.V. (Netherlands) China
7 others
IIa 93/42 EUDAMED record Report an error
Kavo FDA Germany
7 others
I, IIa MDR Website info@kavo.com EUDAMED record Report an error
J. Morita Mfg FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Japan
6 others
IIa MDR, 93/42 Website EUDAMED record Report an error
MK-dent FDA Germany
6 others
IIa 93/42 Website info@mk-dent.com EUDAMED record Report an error
B.A. International EU representative : CB Healthcare Consulting GmbH (Germany) United Kingdom (ex Northern Ireland)
5 others
I, IIa MDR, 93/42 Website info@bainternational.com EUDAMED record Report an error
Foshan Chuangxin Medical Apparatus EU representative : Lotus NL B.V. (Netherlands) China
5 others
IIa 93/42 Website EUDAMED record Report an error
Lares Research FDA EU representative : MDSS GmbH (Germany) United States
4 others
IIa 93/42 Website EUDAMED record Report an error
Snucone FDA EU representative : MDSS GmbH (Germany) South Korea
4 others
IIa 93/42 EUDAMED record Report an error
Ditron Dental FDA EU representative : MedNet EC-REP IIb GmbH (Germany) Israel
3 others
IIa, III 93/42 Website info@ditrondental.com EUDAMED record Report an error
Foshan Joinchamp Medical Device EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
IIa MDR, 93/42 Website EUDAMED record Report an error
Guangdong JINME Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
IIa MDR, 93/42 regulatory-1@jinmedental.com EUDAMED record Report an error
Hu-Friedy Manufacturing EU representative : Hu-Friedy Europe LLC & Co. KG (Germany) United States
3 others
I, IIa MDR EUDAMED record Report an error
Suntem EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
IIa 93/42 EUDAMED record Report an error
General Project FDA Italy
2 others
IIb 93/42 Website info@generalproject.com EUDAMED record Report an error
Tecnomed Italia Italy
2 others
I, IIa MDR, 93/42 Website EUDAMED record Report an error
Z-Systems FDA EU representative : Axxos GmbH (Germany) Switzerland
2 others
IIa 93/42 quality@zsystems.com EUDAMED record Report an error
Finndent Finland
3 others
I, IIa 93/42 Website EUDAMED record Report an error
Antoni Carles FDA Spain
1 other
I, IIa MDR Website EUDAMED record Report an error
ChangZhou BoMedent Medical Technology FDA EU representative : Caretechion GmbH (Germany) China
1 other
IIa MDR, 93/42 Website EUDAMED record Report an error
Chiromega Slovakia
1 other
IIa 93/42 Website EUDAMED record Report an error
Micro-Nx FDA EU representative : Javitech Consulting GmbH (Germany) South Korea
1 other
IIa 93/42 Website EUDAMED record Report an error
Takara Belmont FDA EU representative : Takara Company Europe GmbH (Germany) Japan
1 other
I, IIa MDR EUDAMED record Report an error
BMED Italy I 93/42 Website EUDAMED record Report an error
DTL Dental Equipment Manufacture EU representative : Kingsmead Service B.V. (Netherlands) China IIa MDR Website info@dtl-dent.com EUDAMED record Report an error
Henry Schein FDA EU representative : Henry Schein Services GmbH (Germany) United States I, IIa MDR, 93/42 Website EUDAMED record Report an error
KASO Medical Technology EU representative : Share info GmbH (Germany) China IIa 93/42 EUDAMED record Report an error
Runyes FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Shanwei Perfect Medical Instruments FDA EU representative : SUNGO Europe B.V. (Netherlands) China I, IIa MDR EUDAMED record Report an error
Ultradent FDA EU representative : Ultradent Products GmbH (Germany) Germany, United States I MDR Website info@ultradent.de EUDAMED record Report an error
CB Healthcare Consulting Germany IIa 93/42 EUDAMED record Report an error
Chengdu Sani Medical Equipment FDA EU representative : SUNGO Europe B.V. (Netherlands) China IIa 93/42 Website EUDAMED record Report an error
Chirana Slovakia IIa 93/42 Website EUDAMED record Report an error
Heka Dental A S Denmark IIa 93/42 Website info@heka-dental.dk EUDAMED record Report an error
Ivory Italy IIa 93/42 Website EUDAMED record Report an error
MDT Micro Diamond Technologies FDA EU representative : Obelis s.a. (Belgium) Israel IIa MDR Website info@mdtdental.com EUDAMED record Report an error
Monitex FDA EU representative : MedPath GmbH (Germany) Taiwan I MDR Website EUDAMED record Report an error
Ningbo Jiangbei Woson Medical Instrument EU representative : Caretechion GmbH (Germany) China I, IIa MDR Website EUDAMED record Report an error
Sirona Dental Systems FDA Germany IIa MDR Website contact@dentsplysirona.com EUDAMED record Report an error
Tosi Foshan Medical Equipment EU representative : Lotus NL B.V. (Netherlands) China IIa 93/42 EUDAMED record Report an error
Aksdent Türkiye IIa MDR Website EUDAMED record Report an error
Belmont Manufacturing EU representative : Takara Company Europe GmbH (Germany) Vietnam IIa 93/42 EUDAMED record Report an error
Chirastar Czechia IIa 93/42 Website EUDAMED record Report an error
Dental Devices EU representative : AR Experts B.V. (Netherlands) Israel IIa MDR Website Ra@ab-dent.com EUDAMED record Report an error
DentalMaster(Xiamen) Medical Technology EU representative : Lotus NL B.V. (Netherlands) China IIa MDR EUDAMED record Report an error
E.M.S. Electro Medical Systems FDA EU representative : EMS FRANCE SARL (France) Switzerland I, IIa MDR Website EUDAMED record Report an error
Grupdental Türkiye IIa 93/42 Website EUDAMED record Report an error
Hasharon Dental Center EU representative : Obelis s.a. (Belgium) Israel IIa MDR Website Info@Hasharon-Dental.com EUDAMED record Report an error
J. Morita Tokyo Mfg EU representative : J. MORITA EUROPE GMBH (Germany) Japan IIa 93/42 vigilance@jmtmc.co.jp EUDAMED record Report an error
Prime Dental Products EU representative : Obelis s.a. (Belgium) India I MDR Website EUDAMED record Report an error
Promed FDA Italy IIa MDR, 93/42 Website EUDAMED record Report an error
Shinhung FDA EU representative : AR Experts B.V. (Netherlands) South Korea IIa 93/42 EUDAMED record Report an error
SycoTec FDA Germany I 93/42 Website info@sycotec.eu EUDAMED record Report an error
Toyedent EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Fimet Finland
1 other
I, IIa MDR, 93/42 Website EUDAMED record Report an error
Apoza FDA EU representative : Luana Med. B.V. (Netherlands) Taiwan I MDR Website EUDAMED record Report an error
Aveflor FDA Czechia I MDR Website EUDAMED record Report an error
B. & B. Dental Italy IIa MDR Website info@bebdental.it EUDAMED record Report an error
Bestdent Foshan Medical Equipment EU representative : Lotus NL B.V. (Netherlands) China IIa MDR info@bestdentmed.com EUDAMED record Report an error
Bienair FDA EU representative : Bien-Air Europe Sàrl (France) Switzerland IIa MDR Website regulatory@bienair.com EUDAMED record Report an error
Biodenta FDA EU representative : MedNet EC-REP IIb GmbH (Germany) Switzerland IIa 93/42 info@biodenta.com EUDAMED record Report an error
BPR Swiss EU representative : Klaus Seiler (Germany) Switzerland I, IIa MDR Website info@bpr-swiss.com EUDAMED record Report an error
Carestream Dental FDA EU representative : TROPHY (France) United States I MDR EUDAMED record Report an error
Carmex FDA EU representative : MedNet EC-REP GmbH (Germany) Israel IIa MDR info@carmex.com EUDAMED record Report an error
Crosstex FDA EU representative : ANTEX MEDI SOLUTION (Germany) Pakistan I MDR Website EUDAMED record Report an error
Dentis FDA EU representative : KTR Europe GmbH (Germany) South Korea I, IIa MDR Website EUDAMED record Report an error
Duerrdental FDA Germany IIa MDR Website regulatory@duerrdental.com EUDAMED record Report an error
Edenta FDA Liechtenstein IIa MDR Website EUDAMED record Report an error
FIMS FDA EU representative : Emergo Europe B.V. (Netherlands) South Korea IIa 93/42 EUDAMED record Report an error
Foshan Roson Medical Instruments EU representative : Wellkang Ltd (Northern Ireland) China IIa 93/42 EUDAMED record Report an error
Good Doctors FDA EU representative : Good Doctors Germany GmbH (Germany) South Korea IIa MDR EUDAMED record Report an error
Incidental Türkiye I MDR Website info@incidental.com.tr EUDAMED record Report an error
Kjmedi FDA EU representative : S.B. Pharma GmbH (Germany) South Korea IIa MDR Website EUDAMED record Report an error
Mectron FDA Italy I, IIa MDR Website EUDAMED record Report an error
Medisolaris Türkiye IIa MDR Website info@medisolaris.com EUDAMED record Report an error
Microcopy, A Division of Neo-Flo EU representative : Obelis s.a. (Belgium) United States IIa MDR EUDAMED record Report an error
Motiondental FDA EU representative : Advena Limited (Malta) Taiwan I MDR Website EUDAMED record Report an error
Oncudental Türkiye I, IIa MDR, 93/42 Website EUDAMED record Report an error
Osstem FDA EU representative : Obelis s.a. (Belgium) South Korea IIa MDR EUDAMED record Report an error
Phibo Spain IIa MDR Website EUDAMED record Report an error
Planmeca FDA Finland IIa MDR EUDAMED record Report an error
Proi̇mtech Sağlik Ürünleri̇ Anoni̇m Şi̇rketi̇ FDA Türkiye IIa MDR, 93/42 Website info@bilimplant.com EUDAMED record Report an error
Tealthfoshan EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR Website sales@tealthfoshan.com EUDAMED record Report an error
Advanced Technology Research (A.T.R.) S:R.L Italy IIa MDR Website info@atrdental.com EUDAMED record Report an error
Anle EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR eudamedlogin@anle.cn EUDAMED record Report an error
Arum Dentistry FDA EU representative : MedNet EC-REP IIb GmbH (Germany) South Korea IIa MDR EUDAMED record Report an error
Beyes FDA EU representative : Lotus NL B.V. (Netherlands) Canada IIa MDR Website EUDAMED record Report an error
Biohorizons FDA EU representative : ALTATEC GmbH (Germany) United States IIa MDR Website EUDAMED record Report an error
C-Tech Implant Italy IIa MDR info@c-tech-implant.com EUDAMED record Report an error
Care & Cure Surgico EU representative : CMC Medical Devices & Drugs SL (Spain) Pakistan I MDR info@carecuresurgico.com EUDAMED record Report an error
CSM Implant FDA EU representative : Specculo Limited (Malta) South Korea IIa MDR Website csmheunghb@gmail.com EUDAMED record Report an error
DCI International FDA EU representative : Emergo Europe B.V. (Netherlands) United States IIa MDR Website customerservice@dcionline.com EUDAMED record Report an error
de Götzen FDA Italy I MDR Website qualitydegotzen@acteongroup.com EUDAMED record Report an error
Denjoy Dental FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China I MDR EUDAMED record Report an error
Dental Imaging Technologies FDA EU representative : PaloDEx Group Oy (Finland) United States I MDR EUDAMED record Report an error
Dentium FDA EU representative : Emergo Europe B.V. (Netherlands) South Korea IIa MDR EUDAMED record Report an error
Dentsply FDA Germany I MDR Website info.konstanz@dentsplysirona.com EUDAMED record Report an error
Dentsply Caulk EU representative : Dentsply DeTrey GmbH (Germany) United States I MDR Website EUDAMED record Report an error
DIPLOMAT DENTAL s.r.o Slovakia IIa MDR Website info@diplomat-dental.com EUDAMED record Report an error
Dkl Germany IIa MDR Website info@dkl.de EUDAMED record Report an error
DS Dental Supply Germany I MDR eudamed@ds-dental-supply.productions EUDAMED record Report an error
Escomedical EU representative : MedPath GmbH (Germany) China IIa 93/42 sales@escomedical.com.cn EUDAMED record Report an error
Fairfax Medical Products FDA EU representative : MD REPS Ltd (Northern Ireland) United Kingdom (ex Northern Ireland) IIa 93/42 Website info@stabident.com EUDAMED record Report an error
First Scientific Dental Materials Germany I MDR eudamed@oxford-scientific.de EUDAMED record Report an error
Fomos FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I 93/42 EUDAMED record Report an error
Foshan Akos Medical Instrument EU representative : SUNGO Europe B.V. (Netherlands) China IIa MDR Website info@akosdent.com EUDAMED record Report an error
Foshan ANYE Medical Apparatus Technology EU representative : Share info GmbH (Germany) China IIa MDR EUDAMED record Report an error
Foshan Keju Medical Apparatus EU representative : Share info GmbH (Germany) China IIa MDR Website EUDAMED record Report an error
Foshan Kexiang Medical Instrument EU representative : Share info GmbH (Germany) China IIa MDR Website EUDAMED record Report an error
Foshan Maile Medical Apparatus EU representative : Share info GmbH (Germany) China IIa MDR Website EUDAMED record Report an error
Foshan VinponG Medical Technology EU representative : Share info GmbH (Germany) China IIa MDR EUDAMED record Report an error
Foshan ZIANN Medical Apparatus EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
G&Z Instrumente Austria IIa MDR Website office@g-z-i.at EUDAMED record Report an error
Galbiati Italy IIa 93/42 Website info@galbiati.com EUDAMED record Report an error
Ghimas FDA Italy IIa 93/42 Website EUDAMED record Report an error
Guangdong Hongke Medical Technology EU representative : MedPath GmbH (Germany) China IIa MDR EUDAMED record Report an error
Guangdong Kui Luk Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR Website EUDAMED record Report an error
Guangdong Yadeng Medical Apparatus FDA EU representative : Share info GmbH (Germany) China IIa MDR Website EUDAMED record Report an error
Guangzhou Ajax Medical Equipment FDA EU representative : MedNet EC-REP GmbH (Germany) China IIa MDR EUDAMED record Report an error
Guilin InnoGen Medical Technology EU representative : MedPath GmbH (Germany) China I MDR info@ig-med.com EUDAMED record Report an error
Hahnenkratt FDA Germany IIa MDR Website info@hahnenkratt.com EUDAMED record Report an error
Harvard Dental International Germany I MDR Website eudamed@harvard-dental-international.de EUDAMED record Report an error
Henan Olive Electronic Technology EU representative : MedPath GmbH (Germany) China IIa MDR EUDAMED record Report an error
Hilbro Instruments FDA EU representative : ANTEX MEDI SOLUTION (Germany) Pakistan I MDR sales@hilbro-instruments.com EUDAMED record Report an error
Honsun (Nantong) EU representative : Kingsmead Service B.V. (Netherlands) China I MDR EUDAMED record Report an error
Immanecorp EU representative : CS Active (Latvia) Pakistan I MDR Website EUDAMED record Report an error
Implura Germany IIa MDR, 93/42 Website info@implura.com EUDAMED record Report an error
Ivoclar FDA Liechtenstein I MDR Website EUDAMED record Report an error
Jiangxi Dentalbright Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) China IIa MDR EUDAMED record Report an error
Kaniedenta Germany I MDR eudamed@kaniedenta.productions EUDAMED record Report an error
Lifedent EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR hello@lifedent.cn EUDAMED record Report an error
Maillefer Instruments Holding Sàrl EU representative : Dentsply DeTrey GmbH (Germany) Switzerland I MDR EUDAMED record Report an error
Mariotti & C Italy IIa MDR Website info@mariotti-italy.com EUDAMED record Report an error
Meccomed EU representative : Share info GmbH (Germany) China I MDR mailbox@meccomed.com EUDAMED record Report an error
MegaGen Implant FDA EU representative : MDSS GmbH (Germany) South Korea IIa MDR EUDAMED record Report an error
Morelli FDA EU representative : Nuno Flores (Portugal) Brazil I MDR Website regulatory@morelli.com.br EUDAMED record Report an error
New Idem Italy IIa MDR Website info@idemriuniti.it EUDAMED record Report an error
Ningbo Medsonz Medical Instrument EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR Website EUDAMED record Report an error
Ningbo Youjoy Dental Equipment EU representative : SUNGO Europe B.V. (Netherlands) China IIa MDR ra01@runyes.com EUDAMED record Report an error
Oms Officine Meccaniche Specializzate Italy IIa MDR EUDAMED record Report an error
Orodeka FDA EU representative : SUNGO Europe B.V. (Netherlands) China IIa MDR Website info@orodeka.com EUDAMED record Report an error
Pascal FDA EU representative : Emergo Europe B.V. (Netherlands) United States I MDR Website EUDAMED record Report an error
Poweam EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Premium Plus (Dongguan) EU representative : Premium Plus Poland sp. z o.o. (Poland) China I MDR info@premiumpluschina.com EUDAMED record Report an error
President Dental Germany IIa MDR Website info@presidentdental.com EUDAMED record Report an error
Prilanta Surgical EU representative : ANTEX MEDI SOLUTION (Germany) Pakistan I MDR Website EUDAMED record Report an error
PRIM FDA Spain I MDR Website eudamed1@prim.es EUDAMED record Report an error
Prime Dental Manufacturing FDA EU representative : MedEnvoy Global BV (Netherlands) United States I MDR Website qa@primedentalmfg.com EUDAMED record Report an error
Qureshi Manufacturing EU representative : AF Pharma Service Europe SL (Spain) Pakistan I MDR info@jaconvena.com EUDAMED record Report an error
RDT Austria IIa 93/42 office@g-z-i.at EUDAMED record Report an error
Rebornendo FDA EU representative : Wellkang Ltd (Northern Ireland) China IIa MDR Website Sales4@rebornendo.com EUDAMED record Report an error
REDA Instrumente FDA Germany I MDR Website EUDAMED record Report an error
Saikangmedical FDA EU representative : Everbiz GmbH (Germany) China I MDR Website EUDAMED record Report an error
Shenzhen Perfect Medical Instruments FDA EU representative : SUNGO Europe B.V. (Netherlands) China IIa MDR EUDAMED record Report an error
Shinva FDA EU representative : MedNet EC-REP C IIb GmbH (Germany) China IIa MDR EUDAMED record Report an error
Sichuan Bomesin Dental Equipment EU representative : Llins Service & Consulting GmbH (Germany) China IIa MDR EUDAMED record Report an error
Siger FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Sigmadental Germany I MDR Website EUDAMED record Report an error
Silverfox FDA EU representative : Lotus NL B.V. (Netherlands) China I MDR Website sales@silverfox.cn EUDAMED record Report an error
Simple & Smart Italy IIa MDR Website info@simplesmart.it EUDAMED record Report an error
Solventum FDA Germany I MDR info-medical-eu@solventum.com EUDAMED record Report an error
Spring Health Products FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States I MDR Website customercare@springhealthproducts.com EUDAMED record Report an error
T.P.H. Pol-Intech Poland I MDR Website info@pol-intech.pl EUDAMED record Report an error
Talladium España FDA Spain IIa MDR EUDAMED record Report an error
Tekmil Türkiye I, IIa MDR, 93/42 Website EUDAMED record Report an error
TeKne Dental Italy I MDR Website info@teknedental.com EUDAMED record Report an error
Thrush International EU representative : LORCAN & FYON B.V. (Netherlands) Pakistan I MDR EUDAMED record Report an error
Ttbio FDA EU representative : CMC Medical Devices & Drugs SL (Spain) Taiwan IIa MDR Website EUDAMED record Report an error
Vitali Italy IIa MDR Website info@vitali.com EUDAMED record Report an error
VOCO FDA Germany I MDR Website info@voco.de EUDAMED record Report an error
Warantec FDA EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea IIa 93/42 EUDAMED record Report an error
WHITEsmile FDA Germany I MDR Website info@whitesmile.com EUDAMED record Report an error
Zhengzhou Olive Electronic Technology FDA EU representative : MedPath GmbH (Germany) China IIa MDR EUDAMED record Report an error
Ziacom Its Italy IIa MDR Website EUDAMED record Report an error
Микромотор ООД Bulgaria IIa MDR Website EUDAMED record Report an error
Hailimedical FDA EU representative : phoenix Medtech GmbH (Germany) No model still on the market China IIa MDR EUDAMED record Report an error
Syntechlaser FDA EU representative : MedNet EC-REP GmbH (Germany) No model still on the market China IIb 93/42 Website sales@syntechlaser.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 738

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
Peter Brasseler Holdings, LLC United States Brasseler USA BrioPrep Sterile Diamonds Brasseler USA Sterile Diamond Diamond Brasseler USA Sterile Carbide Forza registered
Hager & Meisinger Gesellschaft mit beschränkter Haftung – Bone Management LUSTER® OKTAGON® OKTAGON Endo Dental Bur registered
DFS - DIAMON GmbH Germany Polishers Bone cutters Carbide burs FG diamond CA diamonds Diamond disc registered
ABRASIVE TECHNOLOGY, INC. United States Two Striper Prodia Select Prodia Sport Prodia Z-series Two Striper BLACK Karat registered
Gebr. Brasseler GmbH & Co. KG Germany KOMET Intraoral dental drill for root posts KOMET Dental Diamond Instruments Diamond Instruments Diamond instrument ECOLINE Diamond Instruments KOMET Abrasive Disc K071352 (2007)
Hopf, Ringleb & Co. GmbH & Cie. Germany HORICO Horico Diamonds registered
Dr. Hopf GmbH & Co. KG Germany Sunshine Diamonds Sunshine DiamondsSunshine Diamonds registered
Ss White Burs, Inc. United States REVELATION DIAMOND PIRANHA DIAMOND G2 DIAMOND EXPRESS LINE DIAMOND GREAT WHITE Z DIAMOND SSW DIAMOND KIT K080687 (2008)
COLTENE/WHALEDENT INC Present in Europe in other categories United States ParaPost ParaPost XT Kodex ParaPost XP ParaPost Taper Lux Max K130137 (2013)
Jota AG Switzerland JOTA C246.FG.012 Diamonds JOTAq registered
STRAUSS & CO - INDUSTRIAL DIAMONDS LTD – dental diamond bur Strauss One dental bur dental bur set dental bur and polisher set Dental Bur Kit registered
NTI - Kahla GmbH Rotary Dental Instruments Germany NTI registered
Dent4You AG Present in Europe in other categories Switzerland Alpen Diamonds DIATECH Diamonds Alpen Carbides Coltolux Comfort Statcare spray Statmatic spray K240801 (2024)
BUSCH & CO. GmbH & Co. KG Germany BUSCH®, BNA® registered
Shofu Dental Corp. United States SUPER-SNAP CERAMISTE DURA-GREEN COMPOMASTER ROBOT POINTS PRO-CUT ROBOT POINT K854347 (1985)
DARBY DENTAL SUPPLY, LLC – Darby Dental Supply, LLC registered
OSUNG MND Co., Ltd. South Korea OSUNG MND registered
TriRock Dental LLC – ECO Dental TriRock Dental registered
MANI, INC. – MANI PEESO REAMERS MANI GATES DRILLS MANI DIA-BURS MANI CARBIDE BURS MANI MI STAINLESS BURS MANI Stainless Burs HARD registered
Neobiotech. co., ltd South Korea Neobiotech Implant System registered
Young Innovations, Inc. United States Johnson-Promident Defend The Orthodontic Store Obtura Spartan Deldent registered
Frontier Dental Supply Inc – House Brand Dentistry House Brand Denstistry House Brad Dentistry registered
3D DENTAL DESIGNS AND DEVELOPMENT, LLC – Luminary-3D Dental Luminary by 3D Dental LL-LED-II Hydrolux by 3D Dental 3D Dental Sabur by 3D Dental registered
DIO Corporation South Korea DIOnavi. Straight Drill DIO Straight Drill FTN Tapered Drill DIOnavi. Initial Drill DIOnavi. Abutment Profile Drill DIOnavi. Profile Drill registered
The Atlanta Dental Supply Company – Advance Dental Products registered
SAFCO DENTAL SUPPLY CO. United States Safco Gates Glidden Drills Safco FG Diamonds Safco FG Composhape Finishing Diamonds Safco ZirconCut FG Diamonds Safco Carbide Bur Safco D1amond registered
SCOTT'S DENTAL SUPPLY L.L.C. – SCOTT'S SELECT GATES DRILLS 6/pk 32mm # 4 SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 3 SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 4 SCOTT'S SELECT PEESO REAMERS 6/pk 32mm # 1-6 ASST SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 1-6 ASST SCOTT'S SELECT GATES DRILLS 6/pk 32mm # 2 registered
US ENDODONTICS, LLC United States EdgeGates™ EdgeBurs® EdgeApex HP™ Edge Apex™ EdgeFlow™ registered
JJGC Indústria e Comércio de Materiais Dentários S/A. Present in Europe in other categories – Neodent Nuvo registered
PRIMA DENTAL MANUFACTURING LIMITED – Carbide rotary dental burs Diamond roatry dental burs registered
Ossvis Co., Ltd. South Korea Step Drill Twist Drill Round Drill Point Drill Guide Full Step Drill Trimming Drill registered
Ls Enterprises, Inc. – Forest registered
Premium Plus International Limited China Premium Plus International Limited Premium Plus K170261 (2017)
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) – Magic Drill Magic Tap Drill Magic Guide Pin Magic Depth Drill Surgical Guide Final Drill Magic Guide Pin SET registered
ICP, INC. United States Dental City registered
Izenimplant Co., Ltd. South Korea ZENEX Guide Twist Drill Step Drill Taper Drill ZENEX Guide Initial Drill Twist Drill Bone Profiler registered
TOP QUALITY MANUFACTURING, INC. – Top Quality Manufacturing registered
Dental Health Products Inc – Health-Tec/DHP Gates Glidden Drills DHP Diamonds DHP Single Use Diamonds DHP Carbide Burs Health-Tec/DHP Disposable Prophy Angles registered
MIG TOOLS INDUSTRIA E COMERCIO LTDA – Migtools registered
3R - INDUSTRIA E COMERCIO EIRELI – DENFINITY registered
Aidite (Qinhuangdao) Technology Co., Ltd. Present in Europe in other categories – Aidite Dental Bur Aidite registered
OSTEOMED LLC United States OsteoMed K162544 (2017)
KEYSTONE DENTAL, INC. United States Restore Prima Genesis Stage-1 Genesis ACTIVE Prima Plus registered
PREMIER DENTAL PRODUCTS COMPANY United States Premier GATES Premier PEESO drills PRIVA DIAMOND Poli-Pro Disks Lumira™ LED Curing Light Premier Spreader K180682 (2019)
Truabutment Korea Co.,Ltd South Korea Final Drill Initial Drill Pilot Drill TruGUIDE Twist Drill Surgical Drill Point Drill registered
Satelec United States ACTEON BUSE PERIO MAINT AIR N GO EASY SP NEWTRON LED 4K3.7V US EMB K110379 (2011)
JMU DENTAL, INC – JMU registered
HU-FRIEDY MFG. CO., LLC United States HU-FRIEDY AMERICAN DENTAL PWR Piezo Tips SYMMETRY Hu-Friedy MFG Co., LLC. HuFriedyGroup K100401 (2010)
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. – CleanCut™ Extended Use Diamond FG US 770.10M CleanCut™ Extended Use Diamond FG 856-021F| CleanCut™ Extended Use Diamond FG US 260.8C CleanCut™ Extended Use Diamond FG 801-016C| CleanCut™ Extended Use Diamond FG 856-016M| CleanCut™ Extended Use Diamond FG US 780.9F registered
INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories United States Integra® Miltex® registered
Shinhung MST Co., Ltd. South Korea Surgical Kit ever GUIDE KIT S-Guide Kit evertis Sinus Kit Short Drill Kit registered
AMERICAN TOOTH INDUSTRIES – CARBIDE BURRS POZZI DIAMONDS FOR LAB USE MOUNTED STONES ABRASIVE WHEELS MALIBU SEPARATORS MALIBU PINCUTTERS registered
ACE SURGICAL SUPPLY CO., INC. United States ACE TRI-CAM Dental Implant System miniMark Dental Implant System TRICAM Dental Implant System Infinity Tru-Fix registered
ASI MEDICAL, INC. United States Advanced Dental System Advanced Endodontic System Triton Extended Worktop - Umbilical Carts Extended Worktop - Self-Contained Carts K123139 (2013)
BIOLINE DENTAL IMPLANT SYSTEMS LTD Israel FG Dental Burs registered
Dentsply Professional – Disposa-Shield® DELTON® NUPRO® MIDWEST® RDH® Upgrade® Nupro Freedom™ registered
Surgikor, LLC United States Final Drill Straight Drill with Stopper without Irrigation Straight Twist Drill Counter Sink Drill Lance Drill Pilot Drill registered
BENCO DENTAL SUPPLY CO. – BENCO OPTIMUM CoreTEC SOLEIL STERLING IRIS registered
TULSA DENTAL PRODUCTS LLC United States Hedstroem Rotary File WaveOne Rotary File Endo Access Bur Lexicon Access Bur SureFlex NiTi Rotary File Endo Access Kit K954790 (1996)
Integration Diagnostics Sweden AB Sweden MulTipeg™ Penguin RFA Penguin MDI MulTipeg™ Driver Osseo 100+ Penguin II registered
United Dental Changzhou China Bondent registered
A-Dec, Inc. United States A-dec K213932 (2022)
Midmark Corp. Present in Europe in other categories United States Midmark Midmark True Definition Scanner K251626 (2025)
OSADA ELECTRIC CO.,LTD. United States SH28S/LVS/MCC6 assy. OSADA PEDO-30W L5M micromotor MC12 motorcord OSADA XL-S30 SH29S/LVS/MCS8 assy. K904742 (1990)
YOUNG DENTAL MANUFACTURING I, LLC – Athena Champion Denticator Young Henry Schein Young Core Biotrol registered
Dentalez Group United States StarDental Instrument Solutions StarDental StarDental Instrument Solutionss StarDental Integrated Solutions K192412 (2020)
Ritter Implants GmbH & Co. KG Present in Europe in other categories United States Ritter Implants Dental System registered
POINTIMPLANT Co., Ltd. Present in Europe in other categories South Korea Final Drill Initial Drill Cortical Drill Bone Profile Drill Fixture Tap Drill Sidecut Drill registered
LOOCID LLC – Loocid BCP registered
CARGUS INTERNATIONAL, INC – MARK3 registered
Chengdu Besmile Medical Technology Co., Ltd. Present in Europe in other categories China Drill Driver Intraoral Scanner registered
DENTECH CORPORATION United States DENTECH registered
Karl Schumacher Dental, LLC – Karl Schumacher registered
Keystone Industries United States BOSWORTH FORTIS Nero Prehma registered
DiaDent Group International South Korea DIA-X FILE GATE DRILLS PEESO REAMERS DIA-KONDENSOR D-LUX+ D-Lux K200809 (2020)
Osstell AB Sweden Osstell Beacon Instrument MEGA ISQ II Instrument Osstell SmartPeg Type 107 Osstell SmartPeg Type 60 Osstell SmartPeg Type 35 Osstell SmartPeg Type 36 K261987 (2026)
BIO CONCEPT Co., Ltd. China Trephine Drill Bone Profiler SR Drill Mini Screw Removal Drill BV Guide Drill,Φ3.5mm/Φ5.7mm,L8.5mm Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L10mm,Guided registered
Vector R&D, Inc. – Vector R&D, Inc registered
BIOTECHNOLOGY INSTITUTE SL – FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0 FRONT-CUTTING DRILL, Ø4.0 MM FRONT-CUTTING DRILL, Ø4.5 MM FRONT-CUTTING DRILL, Ø3.5 MM FRONT-CUTTING DRILL, Ø2.5 MM PUNCH DRILL Ø4 registered
Dentatus AB Sweden Helix Conical Reamers Helix Classic Reamers Classic Standard Reamers Surtex Conical / Tapered Reamers Luscent registered
DEN-MAT HOLDINGS, LLC United States DenMat® SNAP-ON SMILE® Lumineers® ZIRCONIA PRIME Contours™ Finishing & Polishing Discs Refill Pack 3/8" Superfine A.S.A.P.® Indirect+ Extraoral/HP Pre-Polisher Refill K081287 (2008)
Saeshin Precision Co., Ltd. South Korea X-CUBE TRAUS SUS10 TRAUS TRAUS SIP20 SDI10 AHP-85-SS K251407 (2026)
NORIS MEDICAL LTD Israel EZguide Stop Drill Dental Drill Diamond Burr Drill Stopper Fixation screw Countersink Drill registered
Aseptico, Inc. Present in Europe in other categories United States Aseptico MIS OCO Biomedical Sterngold Glidewell Laboratory IVIS ImplantVision K150129 (2015)
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA – Cable MX LED 3M CABLE I-SURGE LED Cable MX LED CABLE MX-i LED 3RD GEN BOARD DMX3 M Bornier BOARD DMX3 M BtoB registered
Bioplate, Inc. United States Bioplate® registered
VERSAH LLC United States Densah Bur Short Densah Bur Densah® Bur G3 G-Stop Keys-Medium-11.5mm G-Stop Keys-Large-15mm VT1525-G registered
OCO BIOMEDICAL INC United States Drill Stop Guided Surgery Final Drill Pilot Drill Osteotomy Former Drill Stop for Pilot Drill CRESTAL FORMER registered
Sable Industries, Inc. United States SABLE M-Style SABLE U-Type SABLE - Doctor's Package SABLE - Hygienist Package SABLE - NSK/STAR Type SABLE - STAR Type K083101 (2009)
Shining 3D Tech Co., Ltd. China SHINING 3D® cameo™ OPERA SYSTEM® INTELLISCAN 3D® Intraoral Scanner SHINING 3D® Intraoral Scanner SHINING3D® registered
Diamond Strauss Instruments Inc – Strauss Diamond registered
ZimVie US Corp LLC United States Driva™ Tapered Screw-Vent® Driva® Spline® Pilot registered
TDV DENTAL LTDA Brazil PRAXIS SANDPAPER DISCS SUPERFIX MANDREL PRAXIS PRAXIS POLISHERS PRAXIS DIAMOND registered
Bonart Co., Ltd. United States IM1 HANDPIECE 20:1 CONTRA ANGLE STRAIGHT HANDPIECE DISPOSABLE SOFT CUPS (BLUE) DISPOSABLE SOFT CUPS (WHITE) LED CURING LIGHT K162856 (2017)
COSMEDENT, INC. – FlexiWheel FlexiDisc Mini 1/2 Coarse FlexiDisc 1/2 Superfine FlexiDisc Mini Starter Kit 5/8 FlexiDisc Regular 3/4 Coarse FlexiDisc Regular 3/4 Extrafine Garnet registered
Kerr Corporation Present in Europe in other categories United States OptiDisc CeraGlaze Unique DiaGloss FibreKor FibreKleer 4x K163064 (2017)
DENTAURUM GmbH & Co.KG United States N.A. tomas® registered
GARRISON DENTAL SOLUTIONS, L.L.C. United States Rally™ eZr™ FitStrip™ LOOP™ LED Curing Light Loop™ Loop™ Calibration and Charging Base K241238 (2024)
HANDPIECE PARTS & REPAIRS, INC. – MEDIDENTA CHOICE PRO EDGE ENDO QUALITY PLUS HHC - PL DENTALAIRE registered
OBTURA SPARTAN ENDODONTICS – Obtura Spartan registered

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