FDA 510(k) Applications for Medical Device Product Code "EIA"
(Unit, Operative Dental)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K000968 | A-DEC, INC. | 3181 DUO DELIVERY SYSTEM | 05/03/2000 |
| K000966 | A-DEC, INC. | 4631 DUO DELIVERY SYSTEM | 05/03/2000 |
| K000967 | A-DEC, INC. | 4635 ASSISTANT'S INSTRUMENTATION | 05/03/2000 |
| K102234 | A-DEC, INC. | A-DEC 200 DENTAL SYSTEM | 11/24/2010 |
| K213932 | A-dec, Inc. | A-dec 300, A-dec 500 | 03/02/2022 |
| K082985 | A-DEC, INC. | A-DEC 334/335 DELIVERY SYSTEM | 12/17/2008 |
| K032756 | A-DEC, INC. | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 | 12/04/2003 |
| K960506 | A-DEC, INC. | A-DEC PERFORMER CONTROL UNIT | 03/25/1996 |
| K051657 | A-DEC, INC. | A-DEC SELF-CONTAINED WATER SYSTEM | 08/30/2005 |
| K962665 | A-DEC, INC. | A-DEC SELF-CONTAINED WATER SYSTEM | 08/22/1996 |
| K032757 | A-DEC, INC. | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE | 12/10/2003 |
| K032070 | A-DEC, INC. | ELCACAM | 08/27/2003 |
| K183121 | AIOBIO Co., Ltd. | Qraypen | 07/18/2019 |
| K984584 | AIR TECHNIQUES, INC. | AIR TECHNIQUES' DENTO-VAC | 03/22/1999 |
| K974204 | AIR TECHNIQUES, INC. | VISTACAM OMNI AND VIASTCAM OMNI (IC) | 01/08/1998 |
| K964271 | AIREL-WEST | IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID | 12/19/1997 |
| K012213 | AMERICAN DENTAL TECHNOLOGIES, INC. | GULLIVER AND CLASSE A | 08/13/2001 |
| K023815 | ANODIA SYSTEMS | C-1805M | 06/19/2003 |
| K023896 | ANODIA SYSTEMS | C-1890 | 06/19/2003 |
| K023213 | ANODIA SYSTEMS | RDH-2000 | 01/16/2003 |
| K981144 | AQUARIUS TECHNOLOGIES, INC. | CLEAN SOURCE I, MODEL CS1000 | 09/15/1998 |
| K040117 | ARROW INDUSTRIES LLC | UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT | 04/21/2004 |
| K050201 | ASEPTICO, INC. | AEU-14CF EXPENDITION | 03/18/2005 |
| K022217 | ASEPTICO, INC. | AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM | 10/24/2002 |
| K101332 | ASEPTICO, INC. | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 | 04/11/2011 |
| K974487 | ASI MEDICAL, INC. | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 | 02/18/1998 |
| K110481 | ASI MEDICAL, INC. | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE | 04/05/2012 |
| K971100 | ATRION MEDICAL PRODUCTS, INC. | ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR | 05/23/1997 |
| K011222 | BELL DENTAL PRODUCTS, LLC. | PORTABELL, MODEL 4200 | 06/25/2001 |
| K000799 | BELMONT EQUIPMENT CORP. | BELMONT UNIT, MODEL 2000 SERIES | 05/17/2000 |
| K983661 | BELMONT EQUIPMENT CORP. | BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES | 01/12/1999 |
| K042759 | BIEN-AIR SA SWITZERLAND | OPTIMA MX | 10/20/2004 |
| K980049 | BLADHS PLAST AB | BONETRAP | 08/11/1998 |
| K020833 | BOYD INDUSTRIES, INC. | BOYD DELIVERY UNIT | 08/08/2002 |
| K063646 | CAMSIGHT CO., INC. | OPTI | 03/07/2007 |
| K983739 | CAMSIGHT, INC. | OPTUM, INTRAORAL CAMERA SYSTEM | 01/19/1999 |
| K091186 | CARESTREAM HEALTH, INC. | KODAK 1500 INTRAORAL CAMERA | 08/18/2009 |
| K112321 | CARESTREAM HEALTH,INC. | CS 1200 | 11/10/2011 |
| K023513 | CASTELLINI S.P.A. | LOGOS JUNIOR DENTAL CHAIR AND UNIT | 03/26/2003 |
| K000837 | CASTELLINI S.P.A. | PUMA DENTAL CHAIR AND UNIT | 07/11/2000 |
| K133412 | CEFLA S.C. | S200, S300 | 01/08/2015 |
| K092917 | CEFLA S.C. | STERN'S S250 NORDAM | 06/24/2010 |
| K062897 | CEFLA S.C.R.L. | C-U2 | 12/14/2006 |
| K013690 | CONFIDENT TECHNOLOGY, INC. | IDENT-A100 INTRAORAL VIDEO CAMERA | 01/30/2002 |
| K081237 | CRAFTMASTER CONTOUR EQUIPMENT, INC. | CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT | 08/25/2008 |
| K041458 | DENIMED ELECTRONICA S.H. | MARE DENTAL OPERATIVE UNIT | 08/24/2004 |
| K020206 | DENT CORP. RESEARCH & DEVELOPMENT | INTRAORAL CAMERA ME-15 | 04/11/2002 |
| K033925 | DENTAL COMPONENTS, INC. | BIOFREE | 04/07/2004 |
| K971727 | DENTAL COMPONENTS, INC. | DCI WATER PURIFIER | 09/12/1997 |
| K980474 | DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. | TELICAM | 04/13/1998 |
| K990844 | DENTALEZ GROUP | STARDENTAL AXCS STERILE WATER SYSTEM | 05/28/1999 |
| K964942 | DENTALPURE CORP. | INFECTION CONTROL CARTRIDGE | 06/19/1997 |
| K973492 | DENTALVIEW, INC. | DENTALVIEW PERIOVIEW SYSTEM | 10/21/1997 |
| K982480 | DENTALVIEW, INC. | PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH. | 09/15/1998 |
| K032904 | DENTSPLY INTL. | ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 | 10/14/2003 |
| K000112 | DENTSPLY INTL. | ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 | 04/13/2000 |
| K981663 | DIGITAL DOC LLC | DIGITAL DOC | 08/10/1998 |
| K130534 | DIPLOMAT DENTAL S.R.O. | DIPLOMAT | 10/30/2013 |
| K040116 | DXM CO., LTD. | HAWK INTRAORAL CAMERA AND ACCESSORIES | 04/20/2004 |
| K991098 | ELECTRO-OPTICAL SCIENCES, INC. | DIFOTI SYSTEM | 06/30/1999 |
| K983285 | ENGLE DENTAL SYSTEMS | ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS | 11/04/1998 |
| K132315 | ERGONOMIC PRODUCTS, INC. | ERGONOMIC PRODUCTS WORKSTATION | 04/18/2014 |
| K050571 | EURODENT S.P.A. | ABSOLUTE AMERICA | 11/02/2005 |
| K991011 | FIBERDENT CORP. | ORASCOPE | 06/23/1999 |
| K173608 | Forest Dental Products, Inc. | Forest Dental Unit | 08/17/2018 |
| K103550 | FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD | YOBOSHI DENTAL UNIT | 01/04/2011 |
| K983847 | GERMIPHENE CORP. | MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT | 12/01/1998 |
| K964796 | GERMIPHENE CORP. | ODYSSEY I DENTAL WATER UNIT | 05/14/1997 |
| K092851 | GLOBAL DENTAL DIRECT, INC. | MODEL GDCH-2000 | 09/29/2009 |
| K102223 | HALLIM DENTECH CO., LTD. | CHALLENGE-EVER | 02/25/2011 |
| K150490 | Heka Dental A/S | UnicLine Mobile | 04/17/2015 |
| K070196 | HR DENTAL PRODUCTS INC | FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT | 01/26/2007 |
| K990479 | HYGENITEK, INC. | HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR | 05/13/1999 |
| K970626 | I.C.S. | EASY CAM | 04/04/1997 |
| K973035 | INNOVATIVE MEDICAL SYSTEMS, INC. | VIOLA II DENTAL CAMERA SYSTEM | 09/24/1997 |
| K981534 | INTEGRA MEDICAL | VIPERCAM | 07/23/1998 |
| K972019 | INTERNATIONAL IMAGING ELECTRONICS | PEFECT SHOT | 07/03/1997 |
| K984332 | INTERNATIONAL TECHNOLOGY CONCEPTS | SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA, | 04/29/1999 |
| K043496 | J. MORITA USA, INC. | SPACELINE EMCIA, MODEL CU580 | 02/16/2005 |
| K052574 | J.O. SUAREZ & CIA, LTDA | COMPACT PLUS - EXTREME - PERFECT PLUS | 07/17/2006 |
| K001445 | JULIE ALLIANCE | SMILIE PC | 07/26/2000 |
| K161488 | KALTENBACH & VOIGT GMBH | ESTETICA Dental Treatment Unit and Accessories | 12/08/2016 |
| K080677 | KALTENBACH & VOIGT GMBH & CO. | COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE | 06/06/2008 |
| K982658 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA ENDOSCOPES FOR DENTAL PROCEDURES | 10/15/1998 |
| K991161 | KAY SEE DENTAL MFG. CO. | HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 | 04/29/1999 |
| K220873 | Lares Research | Perceptive electric dental motor and control unit | 12/15/2022 |
| K984609 | LITE SPECIALTY METAL WORKS, INC. | ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III | 02/09/1999 |
| K021083 | LUMALITE, INC. | VERACAM | 08/30/2002 |
| K962527 | MEDCARE MEDICAL GROUP, INC. | GENERAL PURPOSE DENTAL TRAY | 08/01/1996 |
| K974542 | MEDICAL DYNAMICS, INC. | TRUE VISION, TRUE VISION II | 02/17/1998 |
| K211556 | MegaGen Implant Co., Ltd. | N2 | 04/05/2023 |
| K202963 | Mgnewton Ltd. | ELEC Master, ELEC Master Dual | 05/05/2023 |
| K012744 | MHT OPTIC RESEARCH AG | INTRAORAL LENS OPTION TO SPECTROSHADE | 01/23/2002 |
| K970002 | MICRO MOTORS, INC. | STERILE WATER PUMP | 03/05/1997 |
| K973765 | MICRYLIUM LABORATORIES | BIO-2000 | 11/04/1998 |
| K120239 | MIDMARK | ELEVANCE | 08/24/2012 |
| K003090 | MIDMARK CORP. | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM | 10/18/2000 |
| K041805 | MIRAS MIRROR IMAGING SOLUTIONS, LTD. | MICROSCOPE SYSTEM | 09/21/2004 |
| K963548 | MRLB INTL., INC. | DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED | 01/22/1997 |
| K992893 | MRLB INTL., INC. | DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE | 09/08/1999 |
| K992868 | MRLB INTL., INC. | DENTAPURE DP40 CARTRIDGE | 09/07/1999 |
| K080438 | NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. | DENTAL UNIT WITH CHAIR | 04/04/2008 |
| K213742 | Olsen Ind·stria e ComΘrcio S.A. | Infinity Pro, Logic, Quality, Sprint | 10/19/2022 |
| K180935 | Olsen Industria e Comercio S.A. | Infinity / Infinity Cross Flex Dental Systems | 02/05/2020 |
| K002620 | ORA METRIX, INC. | SURESMILE SYSTEM | 11/16/2000 |
| K183347 | Osstem Implant Co., Ltd. | K3 | 09/04/2019 |
| K152830 | OSSTEM IMPLANT CO.,LTD. | K3 | 04/20/2017 |
| K983735 | PALL MEDICAL | PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE | 01/07/1999 |
| K983731 | PALL MEDICAL | PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE | 12/21/1998 |
| K171872 | Pelton & Crane | P50 Series Dental Operative Unit and Accessories | 04/26/2018 |
| K143696 | PELTON & CRANE | Spirit | 09/18/2015 |
| K962071 | PELTON & CRANE CO. | SPIRIT S1/S2 | 08/06/1996 |
| K972033 | PLANMECA OY | PLANMECA INTRACAM | 06/20/1997 |
| K984013 | PLANMECA OY | PLANMECA INTRACAM STATION | 01/26/1999 |
| K961420 | PLANMECA OY | PROSTYLE COMPACT | 09/10/1996 |
| K081699 | PLANMECA USA, INC. | PLANMECA SOVEREIGN | 08/29/2008 |
| K954471 | POWERS DENTAL & MEDICAL TECHNOLOGY, INC. | POWERS ANTI-BACTERIAL VALVE | 04/15/1996 |
| K132245 | PRO DENTAL SERVICES LLC. | AJAX DENTAL UNIT | 09/05/2014 |
| K090079 | PROGENY, INC. | VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 | 05/01/2009 |
| K980106 | PROMA, INC. | THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES | 08/03/1998 |
| K971278 | PURE CO. | PURE COMPANY FLUID DELIVERY SYSTEM | 07/03/1997 |
| K161734 | RITTER CONCEPT GMBH | Vanguard Dental Unit | 12/09/2016 |
| K043325 | ROLENCE ENTEPRISE, INC. | ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES | 02/11/2005 |
| K100212 | SAFARI DENTAL, INC. | DENTACENTER/EXPEDITION, MODEL SAF-430 | 10/22/2010 |
| K040529 | SATELEC | COCOON HYGIENIST | 08/19/2004 |
| K963778 | SCHICK TECHNOLOGIES, INC. | CDR-CAM | 11/22/1996 |
| K984641 | SCHOELLY FIBEROPTIC, GMBH | FLEXISCOPE OPTOMODUL | 03/29/1999 |
| K984556 | SCHOLLY FIBEROPTIC GMBH | SCICAN CLASSIC | 02/09/1999 |
| K960556 | SCITECH SOLUTIONS, INC. | BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE | 05/08/1996 |
| K973996 | SCITECH SOLUTIONS, INC. | CLEARLINE PLUS, DENTAL WATERLINE FILTER | 02/04/1998 |
| K982009 | SCITECH SOLUTIONS, INC. | ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE | 06/25/1998 |
| K964619 | SDS DENTAL, INC. | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) | 01/22/1997 |
| K063302 | SHANGHAI DENTAL INSTRUMENT FACTORY | SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES | 11/15/2006 |
| K111907 | SHANGHAI DYNAMIC INDUSTRY CO., LTD. | DYNAMIC DU SERIES PORTABLE DENTAL UNIT | 12/02/2011 |
| K052470 | SHANGHAI FIMET MEDICAL INSTRUMENT CO., LTD. | F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT | 11/01/2005 |
| K213749 | Shinhung Company Ltd | G7, Dental Operative Unit and Accessories | 04/03/2023 |
| K151996 | SHINHUNG COMPANY LTD | TAURUS C1 | 01/22/2016 |
| K150909 | Sirona Dental Systems GMBH | INTEGO Family and Accesories | 07/17/2015 |
| K983242 | SIRONA DENTAL SYSTEMS GMBH | SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES | 12/11/1998 |
| K032543 | SIRONA DENTAL SYSTEMS GMBH | SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES | 11/14/2003 |
| K151045 | SIRONA DENTAL SYSTEMS GMBH | TENEO Dental Treatment Unit and Accessories | 07/24/2015 |
| K980577 | SODEXCO | PRINCESS SYRINGE | 05/08/1998 |
| K983625 | SOPRO | S555 INTRAORAL DENTAL CAMERA | 01/11/1999 |
| K990948 | SOPRO | S575 INTRAORAL DOCKING DENTAL CAMERA | 04/21/1999 |
| K012505 | SOPRO | SOPRO595 INTRA ORAL CAMERA | 10/05/2001 |
| K061175 | SOTA PRECISION OPTICS, INC. | CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES | 05/23/2006 |
| K032341 | SOTA PRECISION OPTICS, INC. | INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 | 08/25/2003 |
| K991946 | STERILEX CORP. | ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L | 09/03/1999 |
| K031681 | STERISIL | STERISIL ANTIMICROBIAL TUBING AND BOTTLE | 10/30/2003 |
| K000941 | STERLTECH, INC. | STERLTECH WATER PURIFIER | 04/06/2000 |
| K991035 | SYBRON DENTAL SPECIALTIES, INC. | QUANTEC-E IRRIGATION SYSTEM | 06/24/1999 |
| K992195 | SYBRON DENTAL SPECIALTIES, INC. | QUANTEC-E IRRIGATION SYSTEM 2 | 10/08/1999 |
| K982117 | T.A. COLEMAN ENT. | FLUID CONTROL | 09/04/1998 |
| K152100 | TAKARA BELMONT CORPORATION | Evogue Dental Unit | 01/22/2016 |
| K003265 | TEXAS INSTITUTE FOR CONSERVATIVE DENTISTRY | CLEANAIR/ CLEANWATER UNIT, MODEL 1600 | 12/22/2000 |
| K000577 | THE YOSHIDA DENTAL MFG. CO., LTD. | YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA | 05/05/2000 |
| K981171 | THERATECHNOLOGIES, INC. | ERADIC-ALL | 12/02/1998 |
| K141504 | THEROZONE USA, INC. | T-8000 THEROZONE UNIT | 02/24/2015 |
| K071485 | TPC ADVANCED TECHNOLOGY, INC. | TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 | 08/28/2007 |
| K974238 | TRINITY LABORATORIES, INC. | DENTAL TRAY, STERILE, DISPOSABLE | 02/04/1998 |
| K033419 | TROPHY RADIOLOGIE | STV PRO 2 | 02/02/2004 |
| K001541 | VIDEO DENTAL CONCEPTS, INC. | MINICAM | 07/21/2000 |
| K020957 | VIDEO DENTAL CONCEPTS, INC. | ORACAM | 06/13/2002 |
| K973410 | W. EDWARD JOHANSEN | ULTRACAM | 10/08/1998 |
| K981565 | WAGGONER PRODUCT DEVELOPMENT | BIOCLEAR CONCENTRATE | 10/15/1998 |
| K961409 | WATER SOLUTION TECHNOLOGIES | PORTA'PURE/DENTAL | 06/12/1996 |
| K001878 | WATERCLAVE, L.L.C. | WATER PURIFIER | 08/03/2000 |
| K981937 | WELCH ALLYN, INC. | WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM | 08/24/1998 |
| K082294 | WESTAR MEDICAL PRODUCTS, INC. | WESTAR SERIES DENTAL UNITS | 08/22/2008 |
| K040691 | WIN-US TECHNOLOGY CO., LTD. | INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D | 03/23/2004 |
| K130410 | XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO. | DENTAL UNIT WITH CHAIR | 07/26/2013 |
| K142206 | Zhuhai Siger Medical Equipment Co., Ltd | Dental Unit | 03/13/2015 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
