Miscellaneous devices · 21 CFR 872 Subpart G
Operative Dental Unit
FDA device type “Unit, Operative Dental”.
- Companies listing it
- 9378 makers
- Brands and models
- 483
- 510(k) clearances
- 28618 in five years
- FDA name
- Unit, Operative Dental
510(k) clearances per year, 1976–2026
Companies that list EIA
93 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | SureSmile Advanced Software v 7.6 · SureSmile Aligner Software v 7.6 · SureSmile Ortho Software v 7.6 | 148 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | Luvis Chair (LC700C) | 37 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | N2 · N2 (Cart B Type) · N2 (Continental Type) · N2 (Mount B Type) | 30 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | K3 · K3 V1.2 · K5 · K5 Cart, K5 Mount, K5 Swing | 68 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | Seal-Tight | 203 | 2026 |
| Cefla S.C. | Italy | Maker | C-U2 · PUMA ELI A R M CART; PUMA ELI A R ORTHO; DAMA AMBIDX · PUMA ELI A R; PUMA ELI A R CP; PUMA ELI A R CART; PUMA ELI A R M; PUMA ELI A R M CP · R7 · +8 | 15 | 2026 |
| Stryker | United States | Maker | TPS Console · TPS Micro Drill/Elite Attachment Brush · TPS Standard Attachment Brush · TPS Unidirectional Footswitch | 33 | 2024 |
| Firstar Dental Company | United States | Maker | Firstar Cabinet Mounted Dental Unit · Firstar Cart Mounted Dental Unit · Firstar Chair Mounted Dental Unit · Firstar Wall Mounted Dental Unit | 3 | 2026 |
| Satelec - Acteon Group | United States | Maker | Mini Dock U USB2 · Mini Dock USB2 · S-575 Intraoral Docking Dental Camera · S575 INTRAORAL DOCKING DENTAL CAMER · +6 | 18 | 2024 |
| Dentalez, Inc. | United States | Maker | CORE Delivery Unit · Galaxy Delivery Unit · StarBright Dual Lamp Control System · StarBright Single Lamp Control System | 9 | 2026 |
| Lares Research | United States | Maker | Perceptive electric motor and control · Smoothdrive electric motor system with Fluoresce HD | 8 | 2022 |
| Alliage S/A Industrias Medico Odontologica | Brazil | Maker | Artus Delivery Unit · Mini Delivery Unit · New Versa Water Unit · Syncrus Alcance 3T BV UE Water Unit · +41 | 3 | 2024 |
| Lakong Medical Devices Co., Ltd. | China | Maker | advanceCAM · Laguna 2, Mirage 2 dental chair with delivery unit operatory package | 2 | 2026 |
| Dental Imaging Technologies Corporation | United States | Maker | DEXcam4 HD | 2 | 2026 |
| MGNEWTON Ltd. | South Korea | Maker | ELEC Master, ELEC Master Dual | 2 | 2023 |
| A-dec, Inc. | United States | Maker | A-dec 200 Dental Chair · A-dec 200 Dental Delivery System · A-dec 200 Dental Light · A-dec 200 Support Center, Cuspidor, Assistant's Instrumentation · +28 | 68 | 2022 |
| Planmeca Oy | Finland | Maker | Planmeca Compact i | 25 | 2023 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Midmark Corporation | United States | Maker | MIDMARK · Midmark Dental Delivery System | 7 | 2025 |
| KaVo Dental GmbH | Germany | Maker | 105.5000 - COMFORTdrive System · 105169 - COMFORTtronic 4894 · 107.3570 - COMFORTdrive 200XDR | 2 | 2021 |
| Shinhung Company, Ltd. | South Korea | Maker | G7, Dental Operative Unit and Accessories · TAURUS C1 | 2 | 2023 |
| AIOBIO Co., Ltd. | South Korea | Maker | MouthCAM Pro · Qraypen, Qraypen C | 2 | 2024 |
| Olsen Indústria E Comércio S.A. | Brazil | Maker | Controller, foot, handpiece and cordUnit, operative dental · Unit, operative dental | 2 | 2022 |
| DCI International LLC | United States | Maker | DCI DENTAL UNIT & ACCESSORIES · DCI Edge · Dental Delivery System Series 5 and 5 Plus · Reliance | 1 | 2025 |
| Guangzhou Ajax Medical Equipment Co., Ltd. | China | Maker | Beyond 300 Continental, Beyond 400 Continental · Classic 100,Classic 101,Classic 200,Classic 201,Beyond 300,Beyond 301,Beyond 400,Beyond 401 · Dental Unit(model:AJ10;AJ11;AJ12;AJ15;AJ16;AJ17;AJ18;AJ19;AJ22;AJ25;AJ26;AJ28,AJ21,AJ27) · Mobile Cart · +3 | 1 | 2026 |
| Jiangsu Dynamic Medical Technology Co., Ltd | China | Maker | Portable Dental Unit | 1 | 2023 |
| ProEdge Dental Products | United States | Maker | BluTube | 1 | 2023 |
| Foshan Safety Medical Equipment Co., Ltd. | China | Maker | Dental Unit, Model: Mare · Dental Unit, Model: Mare.1, Mare.2, Mare.3, Mare.4, Mare.5 | 1 | 2024 |
| Guangdong Yadeng Medical Apparatus Co.,Ltd | China | Maker | Integral Dental Unit Model: YD-A4, AD-S1, AD-S3, AD-S6 | 1 | 2025 |
| Mipont Medical Equipment Co., Ltd. | China | Maker | Integral Dental Units | 1 | 2025 |
| Aseptico, Inc. | United States | Maker | AA-100-110 -COMPRESSOR AIRPAC III 110V · AA-100-220 - COMPRESSOR AIRPAC III 220V · AA-12CSB - BRKT ADU-12 CASE LID STANDOFF BRACKET KIT · AA-12HVE - ADAPTER HVE ADU-12 TASKFORCE · +47 | 17 | 2015 |
| Carestream Dental LLC | United States | Maker | CS 1200 · CS 1500 | 11 | 2020 |
| Takara Belmont Corporation | Japan | Maker | Belmont · Evogue Dental Unit · X-Calibur Unit | 7 | 2017 |
| Dxm Co., Ltd. | South Korea | Maker | Hawk · Intraoral Camera and Accessories | 6 | 2020 |
| Asi Medical, Inc. | United States | Maker | Advanced Dental System · Advanced Endodontic System · Triton Dental System · Triton Self Contained Dental System | 5 | 2013 |
| Rolence Ent., Inc. | Taiwan | Maker | elitedent · zoomcam | 5 | 2009 |
| Anodia Systems | United States | Maker | C-1310 · C-1805M · C-1890 · DentaKLEEN · +8 | 4 | 2003 |
| Beaverstate Dental, Inc. | United States | Maker | A-050 · A-100 · A-101 · A-200 · +59 | 2 | 1995 |
| Sota Precision Optics, Inc. | United States | Maker | Claris i310 · Claris i310D | 2 | 2006 |
| Shanghai Dental Instrument Factory Co., Ltd. | China | Maker | SDIF DENTAL CHAIRS WITH | 2 | 2006 |
| Bien-Air Dental, SA | Switzerland | Maker | AP OPTIMA MCX · BOARD DMCX · BOARD DMX · BOARD DMX BASIC · +50 | 1 | 2009 |
| Boyd Industries, Inc. | United States | Maker | CDU415 · CSU320 · CSU351 · CSU351SQ · +7 | 1 | 2002 |
| Ritter Concept GmbH | Germany | Maker | Contact Lite · Contact Lite Comfort · Contact World · Hanging · +8 | 1 | 2016 |
| Digital Doc, LLC | United States | Maker | GLO X90 Illumination Ring · IRIS 2 Intraoral Camera · IRIS LTE Intraoral Camera · IRIS X80 Intraoral Camera · +3 | 1 | 1998 |
| WinUs Technology Co., Ltd. | South Korea | Maker | Dexcam3 · Dexcam4 · Dexcam4 HD · GXC300 · +3 | 1 | 2004 |
| Proma, Inc. | United States | Maker | A Series · Alliant · Domain · Inception | 1 | 1998 |
| Solmetex (Sterisil) | United States | Maker | STERISIL ANTIMICROBIAL TUBING AND BOTTLE | 1 | 2003 |
| Ergonomic Products, Inc. | United States | Maker | Ergonomic Products Workstation | 1 | 2014 |
| KARL STORZ SE & Co. KG | Germany | Maker | Dental Endoscopes | 1 | 1998 |
| Micrylium Laboratories Inc. | Canada | Maker | Lines | 1 | 1998 |
| Safari Dental, Inc. | Canada | Maker | Operative Dental Unit | 1 | 2010 |
| Shanghai Fimet Medical Instrument Co., Ltd. | China | Maker | F1 Series Dental Chairs with Operative Unit | 1 | 2005 |
| Zhuhai Siger Medical Equipment Co Ltd | China | Maker | Dental Unit U300 U500 | 1 | 2015 |
| SPS/Crosstex International | United States | Maker | DentaPure DP365 Cartridge · DentaPure DP40 Cartridge | — | — |
| Beyes Dental Inc | Canada | Maker | Beyes Dental Chair With Operative Unit · Comfortek Mobile Dental System · Comfortek Portable Dental System | — | — |
| Unique Instruments Inc. | United States | Maker | MICDRILL LONG ATTAC IRR. CLIP 5100-015-0271 · MICRODRILL ATTACH. IRR. CLIP 5100-015-251 · TPS MICRO OSC SAW IRR. CLIP 5100-031-500 | — | — |
| J. Morita MFG Corp. | Japan | Maker | MODEL CU580 · SPACELINE EMCIA | — | — |
| AC Equipamentos Medicos e Odontologicos LTDA | Brazil | Maker | Deluxe Assistant Stool · Deluxe Doctor Stool · Standard Assistant Stool · Standard Doctor Stool · +9 | — | — |
| Summit Dental Systems LLC. | United States | Maker | 1402 2 HP Delivery System · 1403 2 HP Rear Mounted Delivery System · 1407 3 HP Delivery System · 1408 3HP Rear Mounted Delivery System · +5 | — | — |
| Straits Orthopaedics (Mfg) Sdn Bhd | Malaysia | Maker | 5100 215 306 BEARING SPACER · 5110-901-912 NOZZLE | — | — |
| Hallim Point Implant Co., Ltd. | South Korea | Maker | CHALLENGE-EVER / HL-2060, HL2060A | — | — |
| DTE Oregon, Inc | United States | Maker | Forest Dental Delivery System, LSM and Elite Unit | — | — |
| QSA Surgical | Pakistan | Maker | — | — | — |
| Sinol Dental Limited | China | Maker | Dental Unit with Chair | — | — |
| Foshan Gladent Medical Instrument Co.,Ltd. | China | Maker | Dental Unit | — | — |
| Acot Plastics (Xiamen) Co., Ltd. | China | Maker | Safe-Tips EZ · Seal- Tight | — | — |
| Carestream Healthcare International Company Limited | China | Maker | CS 1200 · CS 1500 | — | — |
| Kuang Yeu Co. Ltd | Taiwan | Maker | Kuang Yeu | — | — |
| Genesis Dental Technologies, LLC | United States | Maker | AQUASEPT | — | — |
| R.H. Cross Enterprises, Inc. | United States | Maker | Stryker® TPS Micro Drill / Elite Attachment Brush · Stryker® TPS STANDARD ATTACHMENT BRUSH | — | — |
| Steri-Shield Incorporated | United States | Maker | Bracket Label Arm Cover | — | — |
| Biotec, Inc. | United States | Maker | Biotec Dental Operatory Equipment | — | — |
| Modular and Custom Cabinets Ltd. | Canada | Maker | FOREST DENTAL DELIVERY SYSTEM | — | — |
| Thermo Fisher Scientific | United States | Maker | CEDIA Phenytoin II Assay | — | — |
| Benchmark Electronics, Inc | United States | Maker | — | — | — |
| Raumedic AG | Germany | Maker | — | — | — |
| TIDI Products LLC | United States | Maker | — | — | — |
| J. Morita USA, Inc. | United States | Foreign exporter | — | 42 | 2022 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | Bellagio Operatory Package · Laguna Hygiene Operatory Package · Laguna Operatory Package · Laguna Orthodontic Operatory Package · +6 | 3 | 2007 |
| KaVo North America | United States | Lister | Alliance · Spirit | 1 | 2017 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Unit, operative dental | — | — |
| Flight Dental Systems USA Inc. | United States | Repacker / relabeler | A-Series Delivery Unit (A2, A6, A12) A-Series Mobile Cart (MC-1302F, MC-1300F, MC-1300FC, MC-1302F-VAC, MC-1300F-VAC) · A12 Radius Operatory · A6 Radius Operatory · A6 Standard Operatory | — | — |
| Onvet Medical Canada Inc. | Canada | Manufacturer | Mobilio Portable Dental Unit. | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | Beyond 300 Continental, Beyond 400 Continental · Classic 100,Classic 101,Classic 200,Classic 201,Beyond 300,Beyond 301,Beyond 400,Beyond 401 · Dental unit (Model:AJ10; AJ11; AJ12; AJ15; AJ16; AJ17;AJ18,AJ19;AJ22;AJ25;AJ26;AJ28,AJ21,AJ27) · Mobile Cart · +3 | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | Toyo Medical Co. | — | — |
| Sanicure BV | Netherlands | Foreign exporter | Unit, operative dental | — | — |
| Zapalign LLC | United States | Repacker / relabeler | Unit, operative dental | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | KASO MEDICAL TECHNOLOGY Co., LTD | — | — |
| Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi | Türkiye | Foreign exporter | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 Oct 2026 | K260275 | Mobile Dental Solution (Model: DS50, DS70, DS90) | Guangdong JINME Medical Technology Co., Ltd. |
| 7 Aug 2026 | K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. |
| 3 Nov 2025 | K251626 | Midmark Dental Delivery System | Midmark Corporation |
| 17 Jul 2025 | K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business |
| 27 Jun 2025 | K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co.,Ltd |
| 27 May 2025 | K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. |
| 19 Feb 2025 | K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | DCI International LLC |
| 7 Feb 2025 | K242404 | BDC Dental Unit | Bdc Dental Corporation , Ltd. |
| 27 Jan 2025 | K231297 | Firstar Dental Unit | Firstar Dental Company |
| 3 Sep 2024 | K233805 | K5 | Osstem Implant Co., Ltd. Chair Business |
| 21 Mar 2024 | K240754 | N2 | Megagen Implant Co., Ltd. |
| 28 Feb 2024 | K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. |
| 5 May 2023 | K202963 | ELEC Master, ELEC Master Dual | MGNEWTON Ltd. |
| 5 Apr 2023 | K211556 | N2 | Megagen Implant Co., Ltd. |
| 3 Apr 2023 | K213749 | G7, Dental Operative Unit and Accessories | Shinhung Company, Ltd. |
| 15 Dec 2022 | K220873 | Perceptive electric dental motor and control unit | Lares Research |
| 19 Oct 2022 | K213742 | Infinity Pro, Logic, Quality, Sprint | Olsen Indústria E Comércio S.A. |
| 2 Mar 2022 | K213932 | A-dec 300, A-dec 500 | A-dec, Inc. |
| 5 Feb 2020 | K180935 | Infinity / Infinity Cross Flex Dental Systems | Olsen Indústria E Comércio S.A. |
| 4 Sep 2019 | K183347 | K3 | Osstem Implant Co., Ltd. |
| 18 Jul 2019 | K183121 | Qraypen | AIOBIO Co., Ltd. |
| 17 Aug 2018 | K173608 | Forest Dental Unit | Forest Dental Products, Inc. |
| 26 Apr 2018 | K171872 | P50 Series Dental Operative Unit and Accessories | Pelton & Crane |
| 20 Apr 2017 | K152830 | K3 | Osstem Implant Co., Ltd. |
| 9 Dec 2016 | K161734 | Vanguard Dental Unit | Ritter Concept GmbH |
| 8 Dec 2016 | K161488 | ESTETICA Dental Treatment Unit and Accessories | Kaltenbach & Voigt GmbH |
| 22 Jan 2016 | K152100 | Evogue Dental Unit | Takara Belmont Corporation |
| 22 Jan 2016 | K151996 | TAURUS C1 | Shinhung Company, Ltd. |
| 18 Sep 2015 | K143696 | Spirit | Pelton & Crane |
| 24 Jul 2015 | K151045 | TENEO Dental Treatment Unit and Accessories | Dentsply Sirona, Inc. |
| 17 Jul 2015 | K150909 | INTEGO Family and Accesories | Dentsply Sirona, Inc. |
| 17 Apr 2015 | K150490 | UnicLine Mobile | Heka Dental A/S |
| 13 Mar 2015 | K142206 | Dental Unit | Zhuhai Siger Medical Equipment Co Ltd |
| 24 Feb 2015 | K141504 | T-8000 THEROZONE UNIT | Therozone USA, Inc. |
| 8 Jan 2015 | K133412 | S200, S300 | Cefla S.C. |
| 5 Sep 2014 | K132245 | AJAX DENTAL UNIT | Pro Dental Services, LLC |
| 18 Apr 2014 | K132315 | ERGONOMIC PRODUCTS WORKSTATION | Ergonomic Products, Inc. |
| 30 Oct 2013 | K130534 | DIPLOMAT | Diplomat Dental S.R.O. |
| 26 Jul 2013 | K130410 | DENTAL UNIT WITH CHAIR | Xianyang North West Medical Instrument (Group) Co. |
| 24 Aug 2012 | K120239 | ELEVANCE | Midmark Corporation |
| 5 Apr 2012 | K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE | Asi Medical, Inc. |
| 2 Dec 2011 | K111907 | DYNAMIC DU SERIES PORTABLE DENTAL UNIT | Shanghai Dynamic Industry Co., Ltd. |
| 10 Nov 2011 | K112321 | CS 1200 | Carestream Health, Inc. |
| 11 Apr 2011 | K101332 | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 | Aseptico, Inc. |
| 25 Feb 2011 | K102223 | CHALLENGE-EVER | Hallim Dentech Co., Ltd. |
| 4 Jan 2011 | K103550 | YOBOSHI DENTAL UNIT | Fosham Yoboshi Medical Equipment Co., Ltd. |
| 24 Nov 2010 | K102234 | A-DEC 200 DENTAL SYSTEM | A-dec, Inc. |
| 22 Oct 2010 | K100212 | DENTACENTER/EXPEDITION, MODEL SAF-430 | Safari Dental, Inc. |
| 24 Jun 2010 | K092917 | STERN'S S250 NORDAM | Cefla S.C. |
| 29 Sep 2009 | K092851 | MODEL GDCH-2000 | Global Dental Direct, Inc. |
| 18 Aug 2009 | K091186 | KODAK 1500 INTRAORAL CAMERA | Carestream Health, Inc. |
| 1 May 2009 | K090079 | VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 | Progeny, Inc. |
| 17 Dec 2008 | K082985 | A-DEC 334/335 DELIVERY SYSTEM | A-dec, Inc. |
| 29 Aug 2008 | K081699 | PLANMECA SOVEREIGN | Planmeca USA, Inc. |
| 25 Aug 2008 | K081237 | CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT | Craftmaster Contour Equipment, Inc. |
| 22 Aug 2008 | K082294 | WESTAR SERIES DENTAL UNITS | Westar Medical Products, Inc. |
| 6 Jun 2008 | K080677 | COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE | Kaltenbach & Voigt GmbH & Co. |
| 4 Apr 2008 | K080438 | DENTAL UNIT WITH CHAIR | North West Medical Instrument (Group) Co., Ltd. |
| 28 Aug 2007 | K071485 | TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 | Tpc Advanced Technology, Inc. |
| 7 Mar 2007 | K063646 | OPTI | Camsight Co., Inc. |
| 26 Jan 2007 | K070196 | FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT | Hr Dental Products, Inc. |
| 14 Dec 2006 | K062897 | C-U2 | Cefla S.C.R.L. |
| 15 Nov 2006 | K063302 | SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES | Shanghai Dental Instrument Factory Co., Ltd. |
| 17 Jul 2006 | K052574 | COMPACT PLUS - EXTREME - PERFECT PLUS | J.O. Suarez & Cia, Ltda |
| 23 May 2006 | K061175 | CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES | Sota Precision Optics, Inc. |
| 2 Nov 2005 | K050571 | ABSOLUTE AMERICA | Eurodent, Inc. |
| 1 Nov 2005 | K052470 | F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT | Shanghai Fimet Medical Instrument Co., Ltd. |
| 30 Aug 2005 | K051657 | A-DEC SELF-CONTAINED WATER SYSTEM | A-dec, Inc. |
| 18 Mar 2005 | K050201 | AEU-14CF EXPENDITION | Aseptico, Inc. |
| 16 Feb 2005 | K043496 | SPACELINE EMCIA, MODEL CU580 | J. Morita USA, Inc. |
| 11 Feb 2005 | K043325 | ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES | Rolence Enteprise, Inc. |
| 20 Oct 2004 | K042759 | OPTIMA MX | Bien-Air SA Switzerland |
| 21 Sep 2004 | K041805 | MICROSCOPE SYSTEM | Miras Mirror Imaging Solutions, Ltd. |
| 24 Aug 2004 | K041458 | MARE DENTAL OPERATIVE UNIT | Denimed Electronica S.H. |
| 19 Aug 2004 | K040529 | COCOON HYGIENIST | Satelec |
| 21 Apr 2004 | K040117 | UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT | Arrow Industries, LLC |
| 20 Apr 2004 | K040116 | HAWK INTRAORAL CAMERA AND ACCESSORIES | Dxm Co., Ltd. |
| 7 Apr 2004 | K033925 | BIOFREE | Dental Components, Inc. |
| 23 Mar 2004 | K040691 | INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D | WinUs Technology Co., Ltd. |
| 2 Feb 2004 | K033419 | STV PRO 2 | Trophy Radiologie |
| 10 Dec 2003 | K032757 | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE | A-dec, Inc. |
| 4 Dec 2003 | K032756 | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 | A-dec, Inc. |
| 14 Nov 2003 | K032543 | SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES | Dentsply Sirona, Inc. |
| 30 Oct 2003 | K031681 | STERISIL ANTIMICROBIAL TUBING AND BOTTLE | Solmetex (Sterisil) |
| 14 Oct 2003 | K032904 | ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 | Dentsply Intl., Inc. |
| 27 Aug 2003 | K032070 | ELCACAM | A-dec, Inc. |
| 25 Aug 2003 | K032341 | INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 | Sota Precision Optics, Inc. |
| 19 Jun 2003 | K023896 | C-1890 | Anodia Systems |
| 19 Jun 2003 | K023815 | C-1805M | Anodia Systems |
| 26 Mar 2003 | K023513 | LOGOS JUNIOR DENTAL CHAIR AND UNIT | Castellini S.P.A. |
| 16 Jan 2003 | K023213 | RDH-2000 | Anodia Systems |
| 24 Oct 2002 | K022217 | AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM | Aseptico, Inc. |
| 30 Aug 2002 | K021083 | VERACAM | Lumalite, Inc. |
| 8 Aug 2002 | K020833 | BOYD DELIVERY UNIT | Boyd Industries, Inc. |
| 13 Jun 2002 | K020957 | ORACAM | Video Dental Concepts, Inc. |
| 11 Apr 2002 | K020206 | INTRAORAL CAMERA ME-15 | Dent Corp. Research & Development |
| 30 Jan 2002 | K013690 | IDENT-A100 INTRAORAL VIDEO CAMERA | Confident Technology, Inc. |
| 23 Jan 2002 | K012744 | INTRAORAL LENS OPTION TO SPECTROSHADE | Mht Optic Research AG |
| 5 Oct 2001 | K012505 | SOPRO595 INTRA ORAL CAMERA | Satelec - Acteon Group |
| 13 Aug 2001 | K012213 | GULLIVER AND CLASSE A | American Dental Technologies, Inc. |
| 25 Jun 2001 | K011222 | PORTABELL, MODEL 4200 | Bell Dental Products, LLC |
| 22 Dec 2000 | K003265 | CLEANAIR/ CLEANWATER UNIT, MODEL 1600 | Texas Institute For Conservative Dentistry |
| 16 Nov 2000 | K002620 | SURESMILE SYSTEM | Dentsply Sirona, Inc. |
| 18 Oct 2000 | K003090 | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM | Midmark Corporation |
| 3 Aug 2000 | K001878 | WATER PURIFIER | Waterclave, LLC |
| 26 Jul 2000 | K001445 | SMILIE PC | Julie Alliance |
| 21 Jul 2000 | K001541 | MINICAM | Video Dental Concepts, Inc. |
| 11 Jul 2000 | K000837 | PUMA DENTAL CHAIR AND UNIT | Castellini S.P.A. |
| 17 May 2000 | K000799 | BELMONT UNIT, MODEL 2000 SERIES | Belmont Equipment Corp. |
| 5 May 2000 | K000577 | YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA | The Yoshida Dental Mfg. Co., Ltd. |
| 3 May 2000 | K000968 | 3181 DUO DELIVERY SYSTEM | A-dec, Inc. |
| 3 May 2000 | K000967 | 4635 ASSISTANT'S INSTRUMENTATION | A-dec, Inc. |
| 3 May 2000 | K000966 | 4631 DUO DELIVERY SYSTEM | A-dec, Inc. |
| 13 Apr 2000 | K000112 | ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 | Dentsply Intl., Inc. |
| 6 Apr 2000 | K000941 | STERLTECH WATER PURIFIER | Sterltech, Inc. |
| 8 Oct 1999 | K992195 | QUANTEC-E IRRIGATION SYSTEM 2 | Sybron Dental Specialties |
| 8 Sep 1999 | K992893 | DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE | Mrlb Intl., Inc. |
| 7 Sep 1999 | K992868 | DENTAPURE DP40 CARTRIDGE | Mrlb Intl., Inc. |
| 3 Sep 1999 | K991946 | ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L | Sterilex Corp. |
| 30 Jun 1999 | K991098 | DIFOTI SYSTEM | Electro-Optical Sciences, Inc. |
| 24 Jun 1999 | K991035 | QUANTEC-E IRRIGATION SYSTEM | Sybron Dental Specialties |
| 23 Jun 1999 | K991011 | ORASCOPE | Fiberdent Corp. |
| 28 May 1999 | K990844 | STARDENTAL AXCS STERILE WATER SYSTEM | Dentalez Group |
| 13 May 1999 | K990479 | HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR | Hygenitek, Inc. |
| 29 Apr 1999 | K991161 | HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 | Kay See Dental Mfg. Co. |
| 29 Apr 1999 | K984332 | SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA, | International Technology Concepts |
| 21 Apr 1999 | K990948 | S575 INTRAORAL DOCKING DENTAL CAMERA | Satelec - Acteon Group |
| 29 Mar 1999 | K984641 | FLEXISCOPE OPTOMODUL | Schoelly Fiberoptic GmbH |
| 22 Mar 1999 | K984584 | AIR TECHNIQUES' DENTO-VAC | Duerr Dental SE |
| 9 Feb 1999 | K984609 | ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III | Lite Specialty Metal Works, Inc. |
| 9 Feb 1999 | K984556 | SCICAN CLASSIC | Scholly Fiberoptic GmbH |
| 26 Jan 1999 | K984013 | PLANMECA INTRACAM STATION | Planmeca Oy |
| 19 Jan 1999 | K983739 | OPTUM, INTRAORAL CAMERA SYSTEM | Camsight Co., Inc. |
| 12 Jan 1999 | K983661 | BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES | Belmont Equipment Corp. |
| 11 Jan 1999 | K983625 | S555 INTRAORAL DENTAL CAMERA | Satelec - Acteon Group |
| 7 Jan 1999 | K983735 | PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE | Pall Medical |
| 21 Dec 1998 | K983731 | PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE | Pall Medical |
| 11 Dec 1998 | K983242 | SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES | Dentsply Sirona, Inc. |
| 2 Dec 1998 | K981171 | ERADIC-ALL | Theratechnologies, Inc. |
| 1 Dec 1998 | K983847 | MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT | Germiphene Corp. |
| 4 Nov 1998 | K983285 | ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS | Engle Dental Systems |
| 4 Nov 1998 | K973765 | BIO-2000 | Micrylium Laboratories Inc. |
| 15 Oct 1998 | K982658 | KSEA ENDOSCOPES FOR DENTAL PROCEDURES | KARL STORZ SE & Co. KG |
| 15 Oct 1998 | K981565 | BIOCLEAR CONCENTRATE | Waggoner Product Development |
| 8 Oct 1998 | K973410 | ULTRACAM | W. Edward Johansen |
| 15 Sep 1998 | K982480 | PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH. | Dentalview, Inc. |
| 15 Sep 1998 | K981144 | CLEAN SOURCE I, MODEL CS1000 | Aquarius Technologies, Inc. |
| 4 Sep 1998 | K982117 | FLUID CONTROL | T.A. Coleman Ent. |
| 24 Aug 1998 | K981937 | WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM | Welch Allyn, Inc. |
| 11 Aug 1998 | K980049 | BONETRAP | Bladhs Plast AB |
| 10 Aug 1998 | K981663 | DIGITAL DOC | Digital Doc, LLC |
| 3 Aug 1998 | K980106 | THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES | Proma, Inc. |
| 23 Jul 1998 | K981534 | VIPERCAM | Integra Medical |
| 25 Jun 1998 | K982009 | ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE | Scitech Solutions, Inc. |
| 8 May 1998 | K980577 | PRINCESS SYRINGE | Sodexco |
| 13 Apr 1998 | K980474 | TELICAM | Dental/Medical Diagnostic Systems, Inc. |
| 18 Feb 1998 | K974487 | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 | Asi Medical, Inc. |
| 17 Feb 1998 | K974542 | TRUE VISION, TRUE VISION II | Medical Dynamics, Inc. |
| 4 Feb 1998 | K974238 | DENTAL TRAY, STERILE, DISPOSABLE | Trinity Laboratories, Inc. |
| 4 Feb 1998 | K973996 | CLEARLINE PLUS, DENTAL WATERLINE FILTER | Scitech Solutions, Inc. |
| 8 Jan 1998 | K974204 | VISTACAM OMNI AND VIASTCAM OMNI (IC) | Duerr Dental SE |
| 19 Dec 1997 | K964271 | IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID | Airel-West |
| 21 Oct 1997 | K973492 | DENTALVIEW PERIOVIEW SYSTEM | Dentalview, Inc. |
| 24 Sep 1997 | K973035 | VIOLA II DENTAL CAMERA SYSTEM | Innovative Medical Systems, Inc. |
| 12 Sep 1997 | K971727 | DCI WATER PURIFIER | Dental Components, Inc. |
| 3 Jul 1997 | K972019 | PEFECT SHOT | International Imaging Electronics |
| 3 Jul 1997 | K971278 | PURE COMPANY FLUID DELIVERY SYSTEM | Pure Co. |
| 20 Jun 1997 | K972033 | PLANMECA INTRACAM | Planmeca Oy |
| 19 Jun 1997 | K964942 | INFECTION CONTROL CARTRIDGE | Dentalpure Corp. |
| 23 May 1997 | K971100 | ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR | Atrion Medical Products, Inc. |
| 14 May 1997 | K964796 | ODYSSEY I DENTAL WATER UNIT | Germiphene Corp. |
| 4 Apr 1997 | K970626 | EASY CAM | I.c.s. |
| 5 Mar 1997 | K970002 | STERILE WATER PUMP | Micro Motors, Inc. |
| 22 Jan 1997 | K964619 | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) | Sds Dental, Inc. |
| 22 Jan 1997 | K963548 | DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED | Mrlb Intl., Inc. |
| 22 Nov 1996 | K963778 | CDR-CAM | Schick Technologies, Inc. |
| 10 Sep 1996 | K961420 | PROSTYLE COMPACT | Planmeca Oy |
| 22 Aug 1996 | K962665 | A-DEC SELF-CONTAINED WATER SYSTEM | A-dec, Inc. |
| 6 Aug 1996 | K962071 | SPIRIT S1/S2 | Pelton & Crane |
| 1 Aug 1996 | K962527 | GENERAL PURPOSE DENTAL TRAY | Medcare Medical Group, Inc. |
| 12 Jun 1996 | K961409 | PORTA'PURE/DENTAL | Water Solution Technologies |
| 8 May 1996 | K960556 | BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE | Scitech Solutions, Inc. |
| 15 Apr 1996 | K954471 | POWERS ANTI-BACTERIAL VALVE | Powers Dental & Medical Technology, Inc. |
| 25 Mar 1996 | K960506 | A-DEC PERFORMER CONTROL UNIT | A-dec, Inc. |
| 15 Nov 1995 | K953912 | JACOBYSCOPE | PerioView, LLC |
| 19 Sep 1995 | K951074 | STOMAVISION (STV) | Trophy Radiologie |
| 23 May 1995 | K951238 | SAFE-TIPS EZ | Safe Wave Products, Inc. |
| 10 May 1995 | K951019 | INTRAORAL VIDEO SCOPE AND WINDOW TUBE | Cuda Products Co. |
| 18 Apr 1995 | K950175 | THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) | Aqua-Air Medical Devices, Inc. |
| 17 Mar 1995 | K942698 | VACSTAR | Duerr Dental SE |
| 16 Mar 1995 | K943204 | VISTACAM | Duerr Dental SE |
| 1 Mar 1995 | K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER | Pelton & Crane |
| 29 Dec 1994 | K944271 | DENTAL OPERATIVE UNIT ACCESORIES | Dci Intl. |
| 22 Nov 1994 | K944256 | OKTAS INTRA-ORAL DENTAL CAMERA | Oktas |
| 9 Sep 1994 | K942520 | E-VAC-U-ACCESSORIES | Bull Frog Mfg. Co. |
| 2 Sep 1994 | K941476 | MODEL 2600 PROCART | Compressor Technologies, Ltd. |
| 10 Aug 1994 | K941716 | MICRODONTIC LENS | New Image Industries, Inc. |
| 2 Aug 1994 | K940864 | DENTIST WITH ASSISTANT PACK | Sterile Concepts, Inc. |
| 26 Jul 1994 | K941349 | DENTAL TRAY | Cush Medical Products |
| 13 Jul 1994 | K934500 | METASYS AMALGAM SEPARATOR MST1 | Metasys Dental Products, Inc. |
Showing the 200 most recent of 286.
Official records: FDA product classification for EIA · 21 CFR 872.6640.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026