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 |
|---|---|---|---|
| Jun 25, 2001 | K011222 | PORTABELL, MODEL 4200 Bell Dental Products, LLC | EIA |
| Dec 22, 2000 | K003265 | CLEANAIR/ CLEANWATER UNIT, MODEL 1600 Texas Institute For Conservative Dentistry | EIA |
| Nov 16, 2000 | K002620 | SURESMILE SYSTEM Orametrix, Inc. | EIA |
| Oct 18, 2000 | K003090 | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM Midmark Corp. | EIA |
| Aug 3, 2000 | K001878 | WATER PURIFIER Waterclave, LLC | EIA |
| Jul 26, 2000 | K001445 | SMILIE PC Julie Alliance | EIA |
| Jul 21, 2000 | K001541 | MINICAM Video Dental Concepts, Inc. | EIA |
| Jul 11, 2000 | K000837 | PUMA DENTAL CHAIR AND UNIT Castellini S.P.A., IT | EIA |
| May 17, 2000 | K000799 | BELMONT UNIT, MODEL 2000 SERIES Belmont Equipment Corp. | EIA |
| May 5, 2000 | K000577 | YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA The Yoshida Dental Mfg. Co., Ltd., JP | EIA |
| May 3, 2000 | K000968 | 3181 DUO DELIVERY SYSTEM A-Dec, Inc. | EIA |
| May 3, 2000 | K000967 | 4635 ASSISTANT'S INSTRUMENTATION A-Dec, Inc. | EIA |
| May 3, 2000 | K000966 | 4631 DUO DELIVERY SYSTEM A-Dec, Inc. | EIA |
| Apr 13, 2000 | K000112 | ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 Dentsply Intl. | EIA |
| Apr 6, 2000 | K000941 | STERLTECH WATER PURIFIER Sterltech, Inc. | EIA |
| Oct 8, 1999 | K992195 | QUANTEC-E IRRIGATION SYSTEM 2 Sybron Dental Specialties, Inc. | EIA |
| Sep 8, 1999 | K992893 | DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE Mrlb Intl., Inc. | EIA |
| Sep 7, 1999 | K992868 | DENTAPURE DP40 CARTRIDGE Mrlb Intl., Inc. | EIA |
| Sep 3, 1999 | K991946 | ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L Sterilex Corp. | EIA |
| Jun 30, 1999 | K991098 | DIFOTI SYSTEM Electro-Optical Sciences, Inc. | EIA |
| Jun 24, 1999 | K991035 | QUANTEC-E IRRIGATION SYSTEM Sybron Dental Specialties, Inc. | EIA |
| Jun 23, 1999 | K991011 | ORASCOPE Fiberdent Corp. | EIA |
| May 28, 1999 | K990844 | STARDENTAL AXCS STERILE WATER SYSTEM Dentalez Group | EIA |
| May 13, 1999 | K990479 | HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR Hygenitek, Inc., CA | EIA |
| Apr 29, 1999 | K991161 | HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 Kay See Dental Mfg. Co. | EIA |
| Apr 29, 1999 | K984332 | SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA, International Technology Concepts | EIA |
| Apr 21, 1999 | K990948 | S575 INTRAORAL DOCKING DENTAL CAMERA Sopro, FR | EIA |
| Mar 29, 1999 | K984641 | FLEXISCOPE OPTOMODUL Schoelly Fiberoptic GmbH | EIA |
| Mar 22, 1999 | K984584 | AIR TECHNIQUES' DENTO-VAC Air Techniques, Inc. | EIA |
| Feb 9, 1999 | K984609 | ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III Lite Specialty Metal Works, Inc. | EIA |
| Feb 9, 1999 | K984556 | SCICAN CLASSIC Scholly Fiberoptic GmbH, DE | EIA |
| Jan 26, 1999 | K984013 | PLANMECA INTRACAM STATION Planmeca Oy, FI | EIA |
| Jan 19, 1999 | K983739 | OPTUM, INTRAORAL CAMERA SYSTEM Camsight, Inc. | EIA |
| Jan 12, 1999 | K983661 | BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES Belmont Equipment Corp. | EIA |
| Jan 11, 1999 | K983625 | S555 INTRAORAL DENTAL CAMERA Sopro, FR | EIA |
| Jan 7, 1999 | K983735 | PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE Pall Medical | EIA |
| Dec 21, 1998 | K983731 | PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE Pall Medical | EIA |
| Dec 11, 1998 | K983242 | SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES Sirona Dental Systems GmbH | EIA |
| Dec 2, 1998 | K981171 | ERADIC-ALL Theratechnologies, Inc., CA | EIA |
| Dec 1, 1998 | K983847 | MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT Germiphene Corp., CA | EIA |
| Nov 4, 1998 | K983285 | ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS Engle Dental Systems | EIA |
| Nov 4, 1998 | K973765 | BIO-2000 Micrylium Laboratories | EIA |
| Oct 15, 1998 | K982658 | KSEA ENDOSCOPES FOR DENTAL PROCEDURES KARL STORZ Endoscopy-America, Inc. | EIA |
| Oct 15, 1998 | K981565 | BIOCLEAR CONCENTRATE Waggoner Product Development | EIA |
| Oct 8, 1998 | K973410 | ULTRACAM W. Edward Johansen | EIA |
| Sep 15, 1998 | K982480 | PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH. Dentalview, Inc. | EIA |
| Sep 15, 1998 | K981144 | CLEAN SOURCE I, MODEL CS1000 Aquarius Technologies, Inc. | EIA |
| Sep 4, 1998 | K982117 | FLUID CONTROL T.A. Coleman Ent. | EIA |
| Aug 24, 1998 | K981937 | WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM Welch Allyn, Inc. | EIA |
| Aug 11, 1998 | K980049 | BONETRAP Bladhs Plast AB | EIA |
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