Instruments for functional explorations and therapeutic interventionsDental stomatology instrumentsInstruments for dental treatment units
Dental treatment units
EMDN code Z12110101
Manufacturers registered in Europe (EUDAMED) 93
- 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.
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) 224
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.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Premium Plus International Limited | China | Premium Plus | K100854 (2010) |
| Ls Enterprises, Inc. | – | Forest | registered |
| Nakanishi, Inc. Present in Europe in other categories | Japan | NLZ NLX SGL50M SG50MS Multi Pad2 Surgic Pro | K233288 (2024) |
| Integration Diagnostics Sweden AB | Sweden | MulTipeg™ Penguin RFA Penguin MDI MulTipeg™ Driver Osseo 100+ Penguin II | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein Henry Schein Maxima Maxima Essentials PATIET PACKS FOR DENTAL | registered |
| YOUNG DENTAL MANUFACTURING I, LLC | – | Young Henry Schein Denticator Young Core Biotrol Oral-B | registered |
| A-Dec, Inc. | United States | A-dec | K213932 (2022) |
| 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) |
| ASI MEDICAL, INC. | United States | Advanced Dental System Advanced Endodontic System Triton Extended Worktop - Umbilical Carts Extended Worktop - Self-Contained Carts | K110481 (2012) |
| Aseptico, Inc. Present in Europe in other categories | United States | Aseptico MIS OCO Biomedical Sterngold Glidewell Laboratory IVIS ImplantVision | K150129 (2015) |
| Saeshin Precision Co., Ltd. | South Korea | X-CUBE TRAUS SUS10 TRAUS TRAUS SIP20 SDI10 AHP-85-SS | K251407 (2026) |
| W & H Dentalwerk Bürmoos GmbH Present in Europe in other categories | Austria | EM-19 LC S-N2 CAN-Bus S-11 L S-NW CAN-Bus WS-91 L Implantmed Plus II (SI-2102) | K161957 (2016) |
| Peter Brasseler Holdings, LLC | United States | Brasseler USA Forza Forza+ | registered |
| Dentalez Group | United States | StarDental Instrument Solutions StarDental | K162397 (2017) |
| STRADIS MEDICAL, LLC | – | STRADIS Stradis Healthcare | registered |
| 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) |
| Dentsply Professional | – | NUPRO® MIDWEST® RDH® Upgrade® Nupro Freedom™ Nupro MIDWEST® | registered |
| Engle Dental Systems, LLC | United States | Dr. Flip Top Cart Platinum Mobile Cart AS-1 Post Delivery System AS1 Dr./Asst Rear Delivery Cabinet Side Mt Rear Delivery Asst Only E1200 AS1 Delivery System | K983285 (1998) |
| CEFLA SOCIETA' COOPERATIVA | – | Castellini Stern Weber Anthos myray CEFLA | registered |
| TULSA DENTAL PRODUCTS LLC | United States | X-Smart Xsmart X-Smart IQ SureFlex NiTi Rotary File ProMark Calamus | registered |
| HANDPIECE PARTS & REPAIRS, INC. | – | MEDIDENTA CHOICE PRO EDGE ENDO QUALITY PLUS HHC - PL DENTALAIRE | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | TPS Stryker TPS, Saber ContraClean | registered |
| INTRA-LOCK INTERNATIONAL, INC. | – | Delfin2 Delfin Delfin1 | registered |
| META SYSTEMS CO., LTD. | South Korea | Elements Connect EQ-M Apex Connect Apex ID i-ROOT | K210475 (2022) |
| Team Technologies, Inc. | United States | AllPro | K994024 (2000) |
| Medidenta | United States | Medidenta | registered |
| FORUM ENGINEERING TECHNOLOGIES (96) LTD. | Israel | X-Smart® Go Protective silicone sleeve X-Smart® Go Contra-angle (6:1) X-Smart Go Cordless endo motor with integrated apex locator X-Smart® Go Power bank Canal-Pro Detect | K232551 (2024) |
| Midmark Corp. Present in Europe in other categories | United States | Midmark | K251626 (2025) |
| Sable Industries, Inc. | United States | SABLE - Doctor's Package SABLE - Hygienist Package SABLE E-Type 4:1 SABLE E-Type 1:1 SABLE NSK Type 4:1 SABLE NSK Type 1:1 | registered |
| CROSSTEX INTERNATIONAL, INC. Present in Europe in other categories | United States | Twist Prophy Angles Disposable Cup Twist™ Disposable Prophy Angles Brush Twist™ Disposable Prophy Angles Sparkle™ Prophy Angle Twist plus Oscillating Prophy Angle Sparkle™ EZ Contra Angle | registered |
| Micro-Nx Co., Ltd. Present in Europe in other categories | South Korea | ELEC-LED Impla-NX (Model: ISE-270C) Impla-NX (Model: ISE-270M) ELEC ENGINE (Model: ISE-170L) ELEC ENGINE (Model: ISE-170C) ELEC ENGINE (Model: ISE-170) | K231562 (2025) |
| US ENDODONTICS, LLC | United States | EdgeApex HP™ Edge Apex™ EdgeFlow™ | registered |
| Ergonomic Products, Inc. | United States | Harmony Open Bay Workstation | K132315 (2014) |
| NOUVAG AG Present in Europe in other categories | Switzerland | Contra Angle 1:1 Contra Angle 32:1 Clip for internal irrigation needle for Contra Angle 20:1 Clip for Contra Angle 20:1 LED Contra Angle 16:1 NOU-CLEAN SPRAY | K022505 (2003) |
| COLTENE/WHALEDENT INC Present in Europe in other categories | United States | CanalPro | registered |
| ETABLISSEMENTS ANTHOGYR | – | AXIOM® HAND-PIECES / CONTRE-ANGLES IMPULSION | registered |
| Schlumbohm GmbH & Co. KG | Germany | EndoPilot Control Box, Komet EndoPilot Komet CanalPro Jeni Set EndoPilot contra-angle EndoPilot retainer for apexcable EndoPilot Motor | registered |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| Flight Dental Systems | – | Flight Dental Systems | registered |
| Foshan Wenjian Medical Instrument Co., Ltd. | China | wenjian | registered |
| PATTERSON DENTAL SUPPLY, INC. | United States | Patterson® PATTERSON | registered |
| Safari Dentaire Inc | – | Dentacenter Operative Dental Unit | registered |
| ASSOCIATED INDUSTRIES CHINA, INC. | – | AG Neovo | registered |
| Alliage S/A Indústrias Médico Odontológica Present in Europe in other categories | Brazil | Delivery Unit Water Unit | registered |
| Dental Health Products Inc | – | Health-Tec/DHP Disposable Prophy Angles | registered |
| Preventech | – | ESA ST Disposable Prophy Angle Firm Cup Box 100 ESA MW Disposable Prophy Angle Taper Brush Box 100 ESA ST Non Latex Disposable Prophy Angle Soft Cup Box 100 ESA MW Non Latex Disposable Prophy Angle Firm Cup Box 100 ESA MW Disposable Prophy Angle Soft Cup Box 100 ESA ST Disposable Prophy Angle Taper Brush Box 100 | registered |
| Ritter Concept GmbH Present in Europe in other categories | Germany | Vanguard Ultimate Comfort Smart Ultimate Comfort Smart P Contact Lite Comfort Ultimate Comfort Contact World | K161734 (2016) |
| Steri-Shield Products, Inc. | United States | Steri-Shield | K884219 (1989) |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | QUALA | registered |
| HU-FRIEDY MFG. CO., LLC | United States | HU-FRIEDY | registered |
| METREX RESEARCH, LLC Present in Europe in other categories | – | Seal-Tight Spree Safe-Tips EZ | registered |
| SIRONA DENTAL, INC. | – | SCHICK | registered |
| VDW GmbH | – | PROMARK TOUCH PROBE PROMARK FILE CLIP PROMARK CHARGER PROMARK LIP CLIP PROMARK APEX LOCATOR PROMARK RECHARGEABLE NIMH BATTERY | registered |
| AMD Medicom Inc | Canada | MEDICOM DENTICARE MEDICOM DENTICARE SWIVEL DPA, SOFT CUP MEDICOM DENTICARE SWIVEL DPA, FIRM CUP MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSH | registered |
| ASCEND EAGLE INCORPORATED | – | Beesure | registered |
| 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 |
| CeramTec Schweiz GmbH | Switzerland | CERALOG® PL Screwdriver ISO-shaft, long, L 29.2 mm CERALOG® PL Screwdriver ISO-shaft, short, L 20.2 mm CERALOG® PL Implant driver ISO-shaft, L 22.8 mm CERALOG® PL Implant removal driver, L 23.0 mm CERALOG® PL Screwdriver ISO-shaft, L 24.2 mm CERALOG® PL Implant driver ISO-shaft, L 27.8 mm | registered |
| DEXIS LLC | United States | DEXcam3™ intraoral cameras DEXcam4™ Intra-oral camera | registered |
| Dental Basics Inc. | – | Dental Basics | registered |
| ESSENTIAL DENTAL SYSTEMS, INC. | United States | Endo-Express Endo CSV | K111541 (2012) |
| FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD. | China | Dental unit | K231845 (2024) |
| HIOSSEN, INC. | United States | S200EML (Contra) Dental Surgery Hand Piece SM3 SM7 US ( Complete Set ) | K180527 (2018) |
| Hexa Dental | – | Turbo Edge Ergo glide | registered |
| Keystone Industries | United States | FORTIS Nero | registered |
| MAXILL, INC. | United States | IPANA DISPOSABLE PROPHY ANGLES IPANA RECIPROCATING DISPOSABLE PROPHY ANGLES | registered |
| Osstem Implant Co., Ltd._Gasan Branch | – | SM3 | registered |
| Prismatik Dentalcraft, Inc | United States | Glidewell™ | registered |
| Shenzhen Rogin Medical Co., Ltd Present in Europe in other categories | China | ROGIN | K242514 (2025) |
| The Atlanta Dental Supply Company | – | Advance Dental Products | registered |
| Anodia Systems | United States | PRO-KLEEN VELOCITY WATER® Zoral DentaKLEEN® WaterlineX® | K023815 (2003) |
| Bonart Co., Ltd. | United States | IM1 HANDPIECE 20:1 CONTRA ANGLE STRAIGHT HANDPIECE DISPOSABLE SOFT CUPS (BLUE) DISPOSABLE SOFT CUPS (WHITE) | K162856 (2017) |
| Carestream Health, Inc. Present in Europe in other categories | United States | CS 1500 CS 1200 | K112321 (2011) |
| Lares Research, Inc. Present in Europe in other categories | United States | Lares Research Smoothdrive Pastel | K220873 (2022) |
| MEDIVATORS INC. Present in Europe in other categories | United States | DentaPure 365-Day Independent Water Bottle Cartridge DentaPure 365-Day Municipal Cartridge | registered |
| BICON, LLC | United States | – | registered |
| CARGUS INTERNATIONAL, INC | – | MARK3 | registered |
| DENJOY DENTAL CO.,LTD Present in Europe in other categories | China | Integrated Endo System | registered |
| Dentalez Alabama, Inc. | – | Dentalez | registered |
| Dentatus AB | Sweden | Profin Profin with IPR Lamineer Tips IPR Lamineer Tips | registered |
| Digital Doc LLC | United States | Iris PXL | K981663 (1998) |
| Good Doctors Co., Ltd. Present in Europe in other categories | South Korea | File Hook(1pcs) Dr's Finder Lip Hook(3pccs) Dr's Finder NEO | K171867 (2018) |
| ICP, INC. | United States | Dental City | registered |
| Mti Precision Products | United States | LYNX LONG BLUE NOSECONE LYNX 4:1 REDUCTION CONTRA ANGLE LYNX 4:1 REDUCTION NOSECONE LYNX SHORT BLUE NOSECONE | registered |
| Parkell, Inc. Present in Europe in other categories | United States | Foramatron® Parkell® | K002195 (2000) |
| Saeyang Microtech Co., Ltd. | United States | Endo E Class Ki-20 Endo A Class PRO M CLASS | K213897 (2022) |
| Satelec | United States | ACTEON | K040529 (2004) |
| Ss White Burs, Inc. | United States | SSW ENDO | registered |
| BENCO DENTAL SUPPLY CO. | – | Sterling | registered |
| BURKHART DENTAL SUPPLY CO., THE | – | Burkhart Dental Supply Burkhart Contra DPA W/Soft Cup, Teal (144) | registered |
| Foshan Cicada Dental Instrument Co., Ltd. Present in Europe in other categories | China | CICADA | K202075 (2022) |
| ORAMETRIX, INC. Present in Europe in other categories | United States | SureSmile Aligner Software SureSmile Ortho Software SureSmile Advanced Software | K002620 (2000) |
| Perimetrics, Inc. | United States | InnerView® System Handpiece InnerView® System Smart Tips InnerView® System Base Station | K251597 (2025) |
| SCOTT'S DENTAL SUPPLY L.L.C. | – | SCOTT'S ECONOMY P/A SCREW TYPE SCOTT'S ECONOMY P/A SNAP TYPE SCOTT'S 20K CONTRA ANGLE | registered |
| ADVANCED TECHNOLOGY RESEARCH A.T.R. SRL | – | EnDrive | registered |
| AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. | – | BANZAI DPA Soft Gray 4-Web Cup BANZAI DPA Firm White 4-Web Cup | registered |
| DENTAMERICA, INC. | United States | ENDOMAX | K092833 (2010) |
| Gendex Corp. | United States | Gendex GXC-300™ intraoral camera | registered |
| INSTITUT STRAUMANN AG Present in Europe in other categories | Switzerland | Straumann SGL70M Straumann Surgical Motor Pro Set - 120V | registered |
| Karl Storz GmbH & Co. KG Present in Europe in other categories | Germany | n.a. | registered |
| NUSMILE, LTD. | – | Z-Evo | registered |
The 100 most active manufacturers are shown, out of 224.
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- Parent category : Instruments for dental treatment units156 manufacturers