FDA Product Code
FDA Product Code EIA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.6640
510(k) Clearances — 285 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | 2026-08-07 | Traditional | PDF ↗ |
| K251626 | Midmark Dental Delivery System | Midmark Corporation | 2025-11-03 | Traditional | PDF ↗ |
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | 2025-07-17 | Special | PDF ↗ |
| K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., | 2025-06-27 | Traditional | PDF ↗ |
| K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | 2025-05-27 | Traditional | PDF ↗ |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC | 2025-02-19 | Traditional | PDF ↗ |
| K242404 | BDC Dental Unit | Bdc Dental Corporation , Ltd. | 2025-02-07 | Traditional | PDF ↗ |
| K231297 | Firstar Dental Unit | Firstar Dental Company | 2025-01-27 | Traditional | PDF ↗ |
| K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | 2024-09-03 | Traditional | PDF ↗ |
| K240754 | N2 | Megagen Implant Co., Ltd. | 2024-03-21 | Special | PDF ↗ |
| K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | 2024-02-28 | Traditional | PDF ↗ |
| K202963 | ELEC Master, ELEC Master Dual | Mgnewton , Ltd. | 2023-05-05 | Traditional | PDF ↗ |
| K211556 | N2 | Megagen Implant Co., Ltd. | 2023-04-05 | Traditional | PDF ↗ |
| K213749 | G7, Dental Operative Unit and Accessories | Shinhung Company, Ltd. | 2023-04-03 | Traditional | PDF ↗ |
| K220873 | Perceptive electric dental motor and control unit | Lares Research | 2022-12-15 | Traditional | PDF ↗ |
| K213742 | Infinity Pro, Logic, Quality, Sprint | Olsen Indústria E Comércio S.A. | 2022-10-19 | Traditional | PDF ↗ |
| K213932 | A-dec 300, A-dec 500 | A-Dec, Inc. | 2022-03-02 | Traditional | PDF ↗ |
| K180935 | Infinity / Infinity Cross Flex Dental Systems | Olsen Industria E Comercio S.A. | 2020-02-05 | Traditional | PDF ↗ |
| K183347 | K3 | Osstem Implant Co., Ltd. | 2019-09-04 | Traditional | PDF ↗ |
| K183121 | Qraypen | AIOBIO Co., Ltd. | 2019-07-18 | Traditional | PDF ↗ |
| K173608 | Forest Dental Unit | Forest Dental Products, Inc. | 2018-08-17 | Traditional | PDF ↗ |
| K171872 | P50 Series Dental Operative Unit and Accessories | Pelton & Crane | 2018-04-26 | Traditional | PDF ↗ |
| K152830 | K3 | Osstem Implant Co., Ltd. | 2017-04-20 | Traditional | PDF ↗ |
| K161734 | Vanguard Dental Unit | Ritter Concept GmbH | 2016-12-09 | Traditional | PDF ↗ |
| K161488 | ESTETICA Dental Treatment Unit and Accessories | Kaltenbach & Voigt GmbH | 2016-12-08 | Traditional | PDF ↗ |
| K152100 | Evogue Dental Unit | Takara Belmont Corporation | 2016-01-22 | Traditional | PDF ↗ |
| K151996 | TAURUS C1 | Shinhung Company, Ltd. | 2016-01-22 | Traditional | PDF ↗ |
| K143696 | Spirit | Pelton & Crane | 2015-09-18 | Traditional | PDF ↗ |
| K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015-07-24 | Traditional | PDF ↗ |
| K150909 | INTEGO Family and Accesories | Sirona Dental Systems GmbH | 2015-07-17 | Traditional | PDF ↗ |
| K150490 | UnicLine Mobile | Heka Dental A/S | 2015-04-17 | Traditional | PDF ↗ |
| K142206 | Dental Unit | Zhuhai Siger Medical Equipment Co., Ltd. | 2015-03-13 | Traditional | PDF ↗ |
| K141504 | T-8000 THEROZONE UNIT | Therozone USA, Inc. | 2015-02-24 | Traditional | PDF ↗ |
| K133412 | S200, S300 | Cefla S.C. | 2015-01-08 | Traditional | PDF ↗ |
| K132245 | AJAX DENTAL UNIT | Pro Dental Services, LLC | 2014-09-05 | Traditional | PDF ↗ |
| K132315 | ERGONOMIC PRODUCTS WORKSTATION | Ergonomic Products, Inc. | 2014-04-18 | Traditional | PDF ↗ |
| K130534 | DIPLOMAT | Diplomat Dental S.R.O. | 2013-10-30 | Traditional | PDF ↗ |
| K130410 | DENTAL UNIT WITH CHAIR | Xianyang North West Medical Instrument (Group) Co. | 2013-07-26 | Special | PDF ↗ |
| K120239 | ELEVANCE | Midmark | 2012-08-24 | Special | PDF ↗ |
| K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE | Asi Medical, Inc. | 2012-04-05 | Traditional | PDF ↗ |
| K111907 | DYNAMIC DU SERIES PORTABLE DENTAL UNIT | Shanghai Dynamic Industry Co., Ltd. | 2011-12-02 | Traditional | PDF ↗ |
| K112321 | CS 1200 | Carestream Health, Inc. | 2011-11-10 | Traditional | PDF ↗ |
| K101332 | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 | Aseptico, Inc. | 2011-04-11 | Traditional | PDF ↗ |
| K102223 | CHALLENGE-EVER | Hallim Dentech Co., Ltd. | 2011-02-25 | Traditional | PDF ↗ |
| K103550 | YOBOSHI DENTAL UNIT | Fosham Yoboshi Medical Equipment Co., Ltd. | 2011-01-04 | Traditional | PDF ↗ |
| K102234 | A-DEC 200 DENTAL SYSTEM | A-Dec, Inc. | 2010-11-24 | Traditional | PDF ↗ |
| K100212 | DENTACENTER/EXPEDITION, MODEL SAF-430 | Safari Dental, Inc. | 2010-10-22 | Traditional | PDF ↗ |
| K092917 | STERN'S S250 NORDAM | Cefla S.C. | 2010-06-24 | Abbreviated | PDF ↗ |
| K092851 | MODEL GDCH-2000 | Global Dental Direct, Inc. | 2009-09-29 | Traditional | PDF ↗ |
| K091186 | KODAK 1500 INTRAORAL CAMERA | Carestream Health, Inc. | 2009-08-18 | Traditional | PDF ↗ |
| K090079 | VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 | Progeny, Inc. | 2009-05-01 | Traditional | PDF ↗ |
| K082985 | A-DEC 334/335 DELIVERY SYSTEM | A-Dec, Inc. | 2008-12-17 | Traditional | PDF ↗ |
| K081699 | PLANMECA SOVEREIGN | Planmeca USA, Inc. | 2008-08-29 | Traditional | PDF ↗ |
| K081237 | CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT | Craftmaster Contour Equipment, Inc. | 2008-08-25 | Traditional | PDF ↗ |
| K082294 | WESTAR SERIES DENTAL UNITS | Westar Medical Products, Inc. | 2008-08-22 | Traditional | PDF ↗ |
| K080677 | COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE | Kaltenbach & Voigt GmbH & Co. | 2008-06-06 | Traditional | PDF ↗ |
| K080438 | DENTAL UNIT WITH CHAIR | North West Medical Instrument (Group) Co., Ltd. | 2008-04-04 | Traditional | PDF ↗ |
| K071485 | TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 | Tpc Advanced Technology, Inc. | 2007-08-28 | Traditional | PDF ↗ |
| K063646 | OPTI | Camsight Co., Inc. | 2007-03-07 | Traditional | PDF ↗ |
| K070196 | FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT | Hr Dental Products, Inc. | 2007-01-26 | Traditional | PDF ↗ |
| K062897 | C-U2 | Cefla S.C.R.L. | 2006-12-14 | Abbreviated | PDF ↗ |
| K063302 | SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES | Shanghai Dental Instrument Factory | 2006-11-15 | Traditional | PDF ↗ |
| K052574 | COMPACT PLUS - EXTREME - PERFECT PLUS | J.O. Suarez & Cia, Ltda | 2006-07-17 | Traditional | PDF ↗ |
| K061175 | CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES | Sota Precision Optics, Inc. | 2006-05-23 | Special | PDF ↗ |
| K050571 | ABSOLUTE AMERICA | Eurodent S.P.A. | 2005-11-02 | Abbreviated | PDF ↗ |
| K052470 | F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT | Shanghai Fimet Medical Instrument Co., Ltd. | 2005-11-01 | Traditional | PDF ↗ |
| K051657 | A-DEC SELF-CONTAINED WATER SYSTEM | A-Dec, Inc. | 2005-08-30 | Traditional | PDF ↗ |
| K050201 | AEU-14CF EXPENDITION | Aseptico, Inc. | 2005-03-18 | Traditional | PDF ↗ |
| K043496 | SPACELINE EMCIA, MODEL CU580 | J. Morita USA, Inc. | 2005-02-16 | Traditional | PDF ↗ |
| K043325 | ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES | Rolence Enteprise, Inc. | 2005-02-11 | Traditional | PDF ↗ |
| K042759 | OPTIMA MX | Bien-Air SA Switzerland | 2004-10-20 | Traditional | PDF ↗ |
| K041805 | MICROSCOPE SYSTEM | Miras Mirror Imaging Solutions, Ltd. | 2004-09-21 | Traditional | PDF ↗ |
| K041458 | MARE DENTAL OPERATIVE UNIT | Denimed Electronica S.H. | 2004-08-24 | Traditional | PDF ↗ |
| K040529 | COCOON HYGIENIST | Satelec | 2004-08-19 | Traditional | PDF ↗ |
| K040117 | UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT | Arrow Industries, LLC | 2004-04-21 | Traditional | PDF ↗ |
| K040116 | HAWK INTRAORAL CAMERA AND ACCESSORIES | Dxm Co., Ltd. | 2004-04-20 | Traditional | PDF ↗ |
| K033925 | BIOFREE | Dental Components, Inc. | 2004-04-07 | Traditional | PDF ↗ |
| K040691 | INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D | Win-Us Technology Co., Ltd. | 2004-03-23 | Traditional | PDF ↗ |
| K033419 | STV PRO 2 | Trophy Radiologie | 2004-02-02 | Traditional | PDF ↗ |
| K032757 | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE | A-Dec, Inc. | 2003-12-10 | Traditional | PDF ↗ |
| K032756 | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 | A-Dec, Inc. | 2003-12-04 | Traditional | PDF ↗ |
| K032543 | SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES | Sirona Dental Systems GmbH | 2003-11-14 | Traditional | PDF ↗ |
| K031681 | STERISIL ANTIMICROBIAL TUBING AND BOTTLE | Sterisil | 2003-10-30 | Traditional | PDF ↗ |
| K032904 | ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 | Dentsply Intl. | 2003-10-14 | Special | PDF ↗ |
| K032070 | ELCACAM | A-Dec, Inc. | 2003-08-27 | Traditional | PDF ↗ |
| K032341 | INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 | Sota Precision Optics, Inc. | 2003-08-25 | Abbreviated | PDF ↗ |
| K023896 | C-1890 | Anodia Systems | 2003-06-19 | Traditional | PDF ↗ |
| K023815 | C-1805M | Anodia Systems | 2003-06-19 | Traditional | PDF ↗ |
| K023513 | LOGOS JUNIOR DENTAL CHAIR AND UNIT | Castellini S.P.A. | 2003-03-26 | Traditional | PDF ↗ |
| K023213 | RDH-2000 | Anodia Systems | 2003-01-16 | Traditional | PDF ↗ |
| K022217 | AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM | Aseptico, Inc. | 2002-10-24 | Traditional | PDF ↗ |
| K021083 | VERACAM | Lumalite, Inc. | 2002-08-30 | Traditional | PDF ↗ |
| K020833 | BOYD DELIVERY UNIT | Boyd Industries, Inc. | 2002-08-08 | Traditional | PDF ↗ |
| K020957 | ORACAM | Video Dental Concepts, Inc. | 2002-06-13 | Traditional | PDF ↗ |
| K020206 | INTRAORAL CAMERA ME-15 | Dent Corp. Research & Development | 2002-04-11 | Traditional | PDF ↗ |
| K013690 | IDENT-A100 INTRAORAL VIDEO CAMERA | Confident Technology, Inc. | 2002-01-30 | Traditional | PDF ↗ |
| K012744 | INTRAORAL LENS OPTION TO SPECTROSHADE | Mht Optic Research AG | 2002-01-23 | Traditional | PDF ↗ |
| K012505 | SOPRO595 INTRA ORAL CAMERA | Sopro | 2001-10-05 | Traditional | PDF ↗ |
| K012213 | GULLIVER AND CLASSE A | American Dental Technologies, Inc. | 2001-08-13 | Traditional | PDF ↗ |
| K011222 | PORTABELL, MODEL 4200 | Bell Dental Products, LLC | 2001-06-25 | Traditional | PDF ↗ |
Product code EIA · Class I · Dental. Data: openFDA.