Instruments for functional explorations and therapeutic interventionsDental stomatology instruments
Various dental stomatology instruments
EMDN code Z121190
Manufacturers registered in Europe (EUDAMED) 62
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 221
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 |
|---|---|---|---|
| Satelec | United States | ACTEON SP NEWTRON LED 4K3.7V US EMB | K072181 (2007) |
| HU-FRIEDY MFG. CO., LLC | United States | HU-FRIEDY AMERICAN DENTAL PWR Piezo Tips SYMMETRY Hu-Friedy MFG Co., LLC. HuFriedyGroup | K100401 (2010) |
| COLTENE/WHALEDENT INC Present in Europe in other categories | United States | Coltolux SPEC 3 BioSonic | K130137 (2013) |
| Dentsply Professional | – | Cavitron® SofScale™ SoftTip™ | registered |
| OSADA ELECTRIC CO.,LTD. | United States | Golz tip set ST16 PI02-R ST92 ST139 SC point 2 | K844250 (1985) |
| DiaDent Group International | South Korea | D-LUX+ D-Lux SPREADERS PLUGGERS | K200809 (2020) |
| Bonart Co., Ltd. | United States | LED CURING LIGHT L3 LIGHT GUIDE LIGHT CURING UNIT L2/L5 LIGHT GUIDE L5 Charging Dock LED CORDLESS CURING LIGHT | K082971 (2008) |
| OBTURA SPARTAN ENDODONTICS | – | Obtura Spartan | registered |
| Young Innovations, Inc. | United States | Obtura Spartan Deldent Johnson-Promident | registered |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | – | Luminary-3D Dental Luminary by 3D Dental LL-LED-II 3D Endo Dream By 3D Dental 3D Dental | registered |
| BENCO DENTAL SUPPLY CO. | – | SOLEIL BENCO IRIS PRO-SYS MINIBLASTER | registered |
| ASI MEDICAL, INC. | United States | Advanced Dental System Advanced Endodontic System | K123139 (2013) |
| Sirona Dental Systems GmbH Present in Europe in other categories | United States | SIROPERIO SIROSONIC Instrument SIROPREP SIRORETRO SIROSONIC | K072107 (2008) |
| Kerr Corporation Present in Europe in other categories | United States | Light Guide Demi Plus Demi Ultra Demi Ultrasonic Tips | K163064 (2017) |
| Peter Brasseler Holdings, LLC | United States | Brasseler USA | registered |
| Deldent , Ltd. | Israel | Ultrasonic Scaler Insert Delsonic Scaler Insert Delsonic 2000 Scaler JETPOLISHER 2000 JP/JST/JS HANDPIECE MB coupling Midwest | K014238 (2002) |
| Nanning Baolai medical instrument Co.,Ltd | China | Baolai | K140233 (2015) |
| NORDENT MANUFACTURING INC | – | NORDENT MANUFACTURING INC BRASSELER USA BLUE AND GREEN NORDENT MANUFACTURING INC. BURKHART DENTAL | registered |
| DEN-MAT HOLDINGS, LLC | United States | Sapphire® Plus Flashlite® DenMat® MAGNA 4.0 Pro-Select Platinum® Pro-Select3 | K081287 (2008) |
| PREMIER DENTAL PRODUCTS COMPANY | United States | Lumira™ LED Curing Light Premier Spreader Premier SPREADERS Premier | K010195 (2001) |
| Dent4You AG Present in Europe in other categories | Switzerland | Coltolux Comfort US200 BioSonic | K240801 (2024) |
| TULSA DENTAL PRODUCTS LLC | United States | ProRoot MTA ProUltra ProUltra SINE ProUltra PiezoFlow ProUltra Piezo | registered |
| Sonendo, Inc. | United States | Molar Procedure Instrument with Accessories Sealing Cap (Size 6) Sealing Cap (Size 7) Sealing Cap (Size 8) Sealing Cap (Size 5) Premolar CrossFire Procedure Instrument with Matrix | K203302 (2021) |
| DENTMATE TECHNOLOGY CO., LTD. Present in Europe in other categories | Taiwan | LEDEX | K221194 (2022) |
| MAXILL, INC. | United States | LUMAX REPLACEMENT BATTERY LUMAX REPLACEMENT ACRYLIC PROTECTIVE LIGHT SHIELD LUMAX REPLACEMENT HEAD LUMAX LED CURING LIGHT LUMAX CURING LIGHT METER LUMAX ACRYLIC PROTECTIE LIGHT SHIELD | registered |
| AMERICAN EAGLE INSTRUMENTS, INC. | United States | American Eagle Instruments American Eagle Instruments, Inc. | registered |
| Engineered Endodontics, LLC | United States | TUN Ultrasonic Tip | K182145 (2019) |
| PEARSON DENTAL SUPPLIES, INC. | – | Vivid TurboCure Vivid KleenSert Vivid MagnaSert IF-10 30K Vivid MagnaSert IF-50 25k Vivid PiezoKleen Handpiece Vivid MagnaSert IF-100 30K | registered |
| IVOCLAR VIVADENT AKTIENGESELLSCHAFT | – | Bluephase G4 BLUEPHASE STYLE Bluephase PowerCure Bluephase EasyCure BLUEPHASE STYLE 20I | registered |
| CEFLA SOCIETA' COOPERATIVA | – | Stern Weber Anthos Castellini | registered |
| RELIANCE ORTHODONTIC PRODUCTS INC | United States | ETCHMASTER ASK ALL SURFACE KIT | registered |
| BENNETT JACOBY, DDS, MS, INC. | – | BenTips Piezosurgery System BenTips Insert WPUP3A BenTips Mod Tri A3 BenTips Insert WPUI3A BenTips Shaft 90Av1 BenTips Star A3 | registered |
| GROMAN INC. | United States | Etchmaster | K030292 (2003) |
| Micron Corp. | Japan | SS17K YU-100 ULTRA TA-100 AW-100 TA-200 | K171150 (2018) |
| MANI, INC. | – | MANI SPREADERS | registered |
| TPC ADVANCE TECHNOLOGY, INC. | – | TPC | registered |
| EDGE ENDO LLC | – | EdgeSurgicalTip™ #1 EdgeTip™ #8 EdgeSurgicalTip™ #2 EdgeTip™ #6 EdgeSurgicalTip™ #4 EdgeTip™ #1 | registered |
| FKG Dentaire Sàrl | Switzerland | SPREADERS | registered |
| PATTERSON DENTAL SUPPLY, INC. | United States | Patterson® PATTERSON | registered |
| DENTAMERICA, INC. | United States | LITEX SCALEX | K955759 (1996) |
| GARRISON DENTAL SOLUTIONS, L.L.C. | United States | Loop™ Loop™ Calibration and Charging Base | K241238 (2024) |
| Sopro Present in Europe in other categories | France | ACTEON | K223470 (2023) |
| Dentalez Group | United States | StarDental Instrument Solutions StarDental Integrated Solutions | K881253 (1988) |
| JOHNSON-PROMIDENT | – | Clear Blue Johnson-Promident | registered |
| Premium Plus International Limited | China | Premium Plus International Limited Premium Plus | K153514 (2016) |
| USA THINK INC. | – | First Medica | registered |
| Beyes Dental Canada Inc Present in Europe in other categories | United States | Slimax-C Plus | registered |
| DANVILLE MATERIALS, LLC | United States | MICROETCHER PREPSTART PREPAIR | K033215 (2004) |
| DENTAL ENGINEERING LABORATORIES, LLC | United States | Dental Engineering Lab-TFRK | registered |
| ENGLER ENGINEERING CORPORATION | United States | Engler 25K Series Sonus SONUS V Sonus Stack (Insert) Sonus Nose Cone Sonus M4 | K122748 (2013) |
| Flight Dental Systems | – | FLIGHT DENTAL SYSTEMS | registered |
| META SYSTEMS CO., LTD. | South Korea | Demi Pro | K253461 (2025) |
| CAO Group, Inc. Present in Europe in other categories | United States | Ascent OL5 Barrier Sleeve Ascent PX Curing Light Ascent PX Barrier Sleeve Ascent PX Protective Shield Ascent OL5 Curing Light Ascent PX Replacement Wand | K150585 (2015) |
| Gebr. Brasseler GmbH & Co. KG | Germany | KOMET Spreader | registered |
| SCOTT'S DENTAL SUPPLY L.L.C. | – | NAVIFIL PLASTIC CARRIER OBTURATORS 5+1/pk # 45 NAVIFIL PLASTIC CARRIER OBTURATORS 5+1/pk # 30 NAVIFIL PLASTIC CARRIER OBTURATORS 5+1/pk # 50 NAVIFIL PLASTIC CARRIER OBTURATORS 5+1/pk # 25 NAVIFIL PLASTIC CARRIER OBTURATORS 5+1/pk # 40 NAVIFIL PLASTIC CARRIER OBTURATORS 5+1/pk # 35 | registered |
| Dentall co.,Ltd. Present in Europe in other categories | United States | B&Lite S | K170529 (2017) |
| Kulzer, Inc. | United States | Starlight pro | K892456 (1989) |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | Quala | registered |
| Rmo, Inc. | – | FlashMax | registered |
| Dentsply De Trey GmbH | – | SmartLite Focus | registered |
| 3M UNITEK CORPORATION | – | 3M™ Ortholux™ Ortholux™ Luminous | registered |
| Foshan Cicada Dental Instrument Co., Ltd. Present in Europe in other categories | China | CICADA | K192233 (2020) |
| Odne AG | Switzerland | OdneClean OdneClean Tip 220x17 OdneClean Tip OdneClean Tip 220x21 | K233844 (2024) |
| PDT, INC. | United States | PDT, Inc. | registered |
| SOUTH EAST INSTRUMENTS LLC | – | Autoscaler® | registered |
| Vector R&D, Inc. | – | Vector R&D, Inc | registered |
| Aseptico, Inc. Present in Europe in other categories | United States | Aseptico | K130693 (2013) |
| Dentlight Inc. | United States | FUSION Curing Light FUSION Grand Curing Light FUSION Plus Curing Light | K180065 (2019) |
| Dmetec.Co., Ltd. | United States | SkyLight COMPACT S Cleanse S+ | K170104 (2017) |
| Dxm Co., Ltd. Present in Europe in other categories | United States | Cybird SPEC3 | K191221 (2020) |
| Helmut Zepf Medizintechnik GmbH | Germany | HELMUT ZEPF | registered |
| Vista Dental | – | Valiant Curing Light PinkWave Kit | registered |
| Zoll-Dental | – | ZOLL-DENTAL | registered |
| A-Dec, Inc. | United States | A-dec | K100647 (2010) |
| DENTRONIX INC | – | Dentronix | registered |
| Foshan COXO Medical Instrument Co.,Ltd. Present in Europe in other categories | China | COXO | K243921 (2025) |
| Medidenta | United States | Medidenta | registered |
| NANNING VV DENTAL CO., LTD. | China | Seasky Skysea | K163414 (2017) |
| ORMCO CORPORATION | United States | MiniEndo MiniEndo II | registered |
| OSUNG MND Co., Ltd. | South Korea | OSUNG MND | registered |
| S.D.I. USA, INC. | Australia | RADII | registered |
| Smartooth Co., Ltd. | South Korea | Smartooth | K231722 (2024) |
| AIOBIO CO.,LTD | South Korea | AIOBIO | K221275 (2024) |
| Air Techniques, Inc. Present in Europe in other categories | United States | CamX Spectra Caries Detection Aid | K090169 (2009) |
| B& L Biotech, inc. Present in Europe in other categories | South Korea | B&Lite S | registered |
| Carestream Health, Inc. Present in Europe in other categories | United States | CS 1600 | K111423 (2012) |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. Present in Europe in other categories | – | Fluorescence Mode | registered |
| Carl Zeiss Suzhou Co., Ltd. Present in Europe in other categories | China | Fluorescence Mode | K171007 (2018) |
| Cole Instruments Inc | United States | Graft Board Round LED Backlight | registered |
| Crystalmark Dental Systems, Inc. | United States | CRYSTALAIR | registered |
| Globalmed Holdings, LLC | United States | Variable Polarizing Hood | registered |
| JMU DENTAL, INC | – | JMU | registered |
| MEDIVANCE INSTRUMENTS LIMITED | United Kingdom | Velopex AquaCut Fluid Abrasion Unit | registered |
| MICRO MEGA | France | ENDO 1500 MID MEDI | registered |
| ORTEK THERAPEUTICS, INC | United States | Ortek Therapeutics, Inc. | K170822 (2017) |
| ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | – | LEDX-PRO | registered |
| Prismatik Dentalcraft, Inc | United States | Glidewell™ | registered |
| Rønvig Dental Manufacturing A/S | – | DENTO PREP | registered |
| SAFCO DENTAL SUPPLY CO. | United States | Safco Influx LED Curing Light | registered |
The 100 most active manufacturers are shown, out of 221.
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