Unit, Operative Dental
Regulation 872.6640
2510(k)s in 12 months (286 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in EIA
| Company | 510(k)s | Recalls |
|---|---|---|
| A-Dec, Inc. | 25 | 0 |
| Pelton & Crane | 5 | 1 |
| Planmeca Oy | 6 | 0 |
| Aseptico, Inc. | 5 | 0 |
| Ace Surgical Supply Co., Inc. | 4 | 0 |
| Air Techniques, Inc. | 4 | 0 |
| Asi Medical, Inc. | 3 | 1 |
| Scitech Solutions, Inc. | 4 | 0 |
| Sds Dental, Inc. | 4 | 0 |
| Sirona Dental Systems GmbH | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2009 | K091186 | KODAK 1500 INTRAORAL CAMERA Carestream Health, Inc. | EIA |
| May 1, 2009 | K090079 | VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 Progeny, Inc. | EIA |
| Dec 17, 2008 | K082985 | A-DEC 334/335 DELIVERY SYSTEM A-Dec, Inc. | EIA |
| Aug 29, 2008 | K081699 | PLANMECA SOVEREIGN Planmeca USA, Inc. | EIA |
| Aug 25, 2008 | K081237 | CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT Craftmaster Contour Equipment, Inc. | EIA |
| Aug 22, 2008 | K082294 | WESTAR SERIES DENTAL UNITS Westar Medical Products, Inc. | EIA |
| Jun 6, 2008 | K080677 | COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE Kaltenbach & Voigt GmbH & Co. | EIA |
| Apr 4, 2008 | K080438 | DENTAL UNIT WITH CHAIR North West Medical Instrument (Group) Co., Ltd., CN | EIA |
| Aug 28, 2007 | K071485 | TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 Tpc Advanced Technology, Inc. | EIA |
| Mar 7, 2007 | K063646 | OPTI Camsight Co., Inc. | EIA |
| Jan 26, 2007 | K070196 | FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT Hr Dental Products, Inc., CA | EIA |
| Dec 14, 2006 | K062897 | C-U2 Cefla S.C.R.L. | EIA |
| Nov 15, 2006 | K063302 | SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES Shanghai Dental Instrument Factory | EIA |
| Jul 17, 2006 | K052574 | COMPACT PLUS - EXTREME - PERFECT PLUS J.O. Suarez & Cia, Ltda, BR | EIA |
| May 23, 2006 | K061175 | CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES Sota Precision Optics, Inc. | EIA |
| Nov 2, 2005 | K050571 | ABSOLUTE AMERICA Eurodent S.P.A. | EIA |
| Nov 1, 2005 | K052470 | F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT Shanghai Fimet Medical Instrument Co., Ltd. | EIA |
| Aug 30, 2005 | K051657 | A-DEC SELF-CONTAINED WATER SYSTEM A-Dec, Inc. | EIA |
| Mar 18, 2005 | K050201 | AEU-14CF EXPENDITION Aseptico, Inc. | EIA |
| Feb 16, 2005 | K043496 | SPACELINE EMCIA, MODEL CU580 J. Morita USA, Inc. | EIA |
| Feb 11, 2005 | K043325 | ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES Rolence Enteprise, Inc., TW | EIA |
| Oct 20, 2004 | K042759 | OPTIMA MX Bien-Air SA Switzerland, CH | EIA |
| Sep 21, 2004 | K041805 | MICROSCOPE SYSTEM Miras Mirror Imaging Solutions, Ltd., IL | EIA |
| Aug 24, 2004 | K041458 | MARE DENTAL OPERATIVE UNIT Denimed Electronica S.H. | EIA |
| Aug 19, 2004 | K040529 | COCOON HYGIENIST Satelec | EIA |
| Apr 21, 2004 | K040117 | UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT Arrow Industries, LLC | EIA |
| Apr 20, 2004 | K040116 | HAWK INTRAORAL CAMERA AND ACCESSORIES Dxm Co., Ltd. | EIA |
| Apr 7, 2004 | K033925 | BIOFREE Dental Components, Inc. | EIA |
| Mar 23, 2004 | K040691 | INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D Win-Us Technology Co., Ltd. | EIA |
| Feb 2, 2004 | K033419 | STV PRO 2 Trophy Radiologie, FR | EIA |
| Dec 10, 2003 | K032757 | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE A-Dec, Inc. | EIA |
| Dec 4, 2003 | K032756 | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 A-Dec, Inc. | EIA |
| Nov 14, 2003 | K032543 | SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES Sirona Dental Systems GmbH | EIA |
| Oct 30, 2003 | K031681 | STERISIL ANTIMICROBIAL TUBING AND BOTTLE Sterisil | EIA |
| Oct 14, 2003 | K032904 | ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 Dentsply Intl. | EIA |
| Aug 27, 2003 | K032070 | ELCACAM A-Dec, Inc. | EIA |
| Aug 25, 2003 | K032341 | INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 Sota Precision Optics, Inc. | EIA |
| Jun 19, 2003 | K023896 | C-1890 Anodia Systems | EIA |
| Jun 19, 2003 | K023815 | C-1805M Anodia Systems | EIA |
| Mar 26, 2003 | K023513 | LOGOS JUNIOR DENTAL CHAIR AND UNIT Castellini S.P.A., IT | EIA |
| Jan 16, 2003 | K023213 | RDH-2000 Anodia Systems | EIA |
| Oct 24, 2002 | K022217 | AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM Aseptico, Inc. | EIA |
| Aug 30, 2002 | K021083 | VERACAM Lumalite, Inc. | EIA |
| Aug 8, 2002 | K020833 | BOYD DELIVERY UNIT Boyd Industries, Inc. | EIA |
| Jun 13, 2002 | K020957 | ORACAM Video Dental Concepts, Inc. | EIA |
| Apr 11, 2002 | K020206 | INTRAORAL CAMERA ME-15 Dent Corp. Research & Development | EIA |
| Jan 30, 2002 | K013690 | IDENT-A100 INTRAORAL VIDEO CAMERA Confident Technology, Inc. | EIA |
| Jan 23, 2002 | K012744 | INTRAORAL LENS OPTION TO SPECTROSHADE Mht Optic Research AG, CH | EIA |
| Oct 5, 2001 | K012505 | SOPRO595 INTRA ORAL CAMERA Sopro, FR | EIA |
| Aug 13, 2001 | K012213 | GULLIVER AND CLASSE A American Dental Technologies, Inc. | EIA |
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