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 10, 1998 | K981663 | DIGITAL DOC Digital Doc, LLC | EIA |
| Aug 3, 1998 | K980106 | THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES Proma, Inc. | EIA |
| Jul 23, 1998 | K981534 | VIPERCAM Integra Medical | EIA |
| Jun 25, 1998 | K982009 | ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE Scitech Solutions, Inc. | EIA |
| May 8, 1998 | K980577 | PRINCESS SYRINGE Sodexco | EIA |
| Apr 13, 1998 | K980474 | TELICAM Dental/Medical Diagnostic Systems, Inc. | EIA |
| Feb 18, 1998 | K974487 | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 Asi Medical, Inc. | EIA |
| Feb 17, 1998 | K974542 | TRUE VISION, TRUE VISION II Medical Dynamics, Inc. | EIA |
| Feb 4, 1998 | K974238 | DENTAL TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. | EIA |
| Feb 4, 1998 | K973996 | CLEARLINE PLUS, DENTAL WATERLINE FILTER Scitech Solutions, Inc. | EIA |
| Jan 8, 1998 | K974204 | VISTACAM OMNI AND VIASTCAM OMNI (IC) Air Techniques, Inc. | EIA |
| Dec 19, 1997 | K964271 | IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID Airel-West | EIA |
| Oct 21, 1997 | K973492 | DENTALVIEW PERIOVIEW SYSTEM Dentalview, Inc. | EIA |
| Sep 24, 1997 | K973035 | VIOLA II DENTAL CAMERA SYSTEM Innovative Medical Systems, Inc. | EIA |
| Sep 12, 1997 | K971727 | DCI WATER PURIFIER Dental Components, Inc. | EIA |
| Jul 3, 1997 | K972019 | PEFECT SHOT International Imaging Electronics | EIA |
| Jul 3, 1997 | K971278 | PURE COMPANY FLUID DELIVERY SYSTEM Pure Co. | EIA |
| Jun 20, 1997 | K972033 | PLANMECA INTRACAM Planmeca Oy, FI | EIA |
| Jun 19, 1997 | K964942 | INFECTION CONTROL CARTRIDGE Dentalpure Corp. | EIA |
| May 23, 1997 | K971100 | ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR Atrion Medical Products, Inc. | EIA |
| May 14, 1997 | K964796 | ODYSSEY I DENTAL WATER UNIT Germiphene Corp., CA | EIA |
| Apr 4, 1997 | K970626 | EASY CAM I.C.S. | EIA |
| Mar 5, 1997 | K970002 | STERILE WATER PUMP Micro Motors, Inc. | EIA |
| Jan 22, 1997 | K964619 | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) Sds Dental, Inc. | EIA |
| Jan 22, 1997 | K963548 | DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED Mrlb Intl., Inc. | EIA |
| Nov 22, 1996 | K963778 | CDR-CAM Schick Technologies, Inc. | EIA |
| Sep 10, 1996 | K961420 | PROSTYLE COMPACT Planmeca Oy, FI | EIA |
| Aug 22, 1996 | K962665 | A-DEC SELF-CONTAINED WATER SYSTEM A-Dec, Inc. | EIA |
| Aug 6, 1996 | K962071 | SPIRIT S1/S2 Pelton & Crane Co. | EIA |
| Aug 1, 1996 | K962527 | GENERAL PURPOSE DENTAL TRAY Medcare Medical Group, Inc. | EIA |
| Jun 12, 1996 | K961409 | PORTA'PURE/DENTAL Water Solution Technologies | EIA |
| May 8, 1996 | K960556 | BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE Scitech Solutions, Inc. | EIA |
| Apr 15, 1996 | K954471 | POWERS ANTI-BACTERIAL VALVE Powers Dental & Medical Technology, Inc. | EIA |
| Mar 25, 1996 | K960506 | A-DEC PERFORMER CONTROL UNIT A-Dec, Inc. | EIA |
| Nov 15, 1995 | K953912 | JACOBYSCOPE Perioview, Inc. | EIA |
| Sep 19, 1995 | K951074 | STOMAVISION (STV) Trophy Radiologie, FR | EIA |
| May 23, 1995 | K951238 | SAFE-TIPS EZ Safe Wave Products, Inc. | EIA |
| May 10, 1995 | K951019 | INTRAORAL VIDEO SCOPE AND WINDOW TUBE Cuda Products Co. | EIA |
| Apr 18, 1995 | K950175 | THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) Aqua-Air Medical Devices, Inc. | EIA |
| Mar 17, 1995 | K942698 | VACSTAR Air Techniques, Inc. | EIA |
| Mar 16, 1995 | K943204 | VISTACAM Air Techniques, Inc. | EIA |
| Mar 1, 1995 | K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER Pelton & Crane Co. | EIA |
| Dec 29, 1994 | K944271 | DENTAL OPERATIVE UNIT ACCESORIES Dci Intl. | EIA |
| Nov 22, 1994 | K944256 | OKTAS INTRA-ORAL DENTAL CAMERA Oktas | EIA |
| Sep 9, 1994 | K942520 | E-VAC-U-ACCESSORIES Bull Frog Mfg. Co. | EIA |
| Sep 2, 1994 | K941476 | MODEL 2600 PROCART Compressor Technologies, Ltd. | EIA |
| Aug 10, 1994 | K941716 | MICRODONTIC LENS New Image Industries, Inc. | EIA |
| Aug 2, 1994 | K940864 | DENTIST WITH ASSISTANT PACK Sterile Concepts, Inc. | EIA |
| Jul 26, 1994 | K941349 | DENTAL TRAY Cush Medical Products | EIA |
| Jul 13, 1994 | K934500 | METASYS AMALGAM SEPARATOR MST1 Metasys Dental Products, Inc., CA | EIA |
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