Handpiece, Air-Powered, Dental
Regulation 872.4200
4510(k)s in 12 months (263 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in EFB
| Company | 510(k)s | Recalls |
|---|---|---|
| A-Dec, Inc. | 19 | 0 |
| Nakanishi, Inc. | 10 | 1 |
| Dentsply Intl. | 8 | 0 |
| Micro Motors, Inc. | 7 | 0 |
| Dentalez, Inc. | 6 | 0 |
| E.M.S Electro Medical Systems S.A | 6 | 0 |
| J. Morita USA, Inc. | 5 | 0 |
| Midwest | 5 | 0 |
| Mti Precision Products | 4 | 1 |
| Nsk Nakanishi, Inc. | 5 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 1999 | K991701 | MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) Nsk Nakanishi, Inc., JP | EFB |
| Feb 23, 1999 | K984244 | ORL-E-92 SURGICAL DRILL SYSTEM Bien Air USA, Inc. | EFB |
| Feb 9, 1999 | K981679 | TCM 3000 AND TCM ENDO NOUVAG AG, DE | EFB |
| Dec 10, 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P Bien Air USA, Inc. | EFB |
| Nov 18, 1998 | K983168 | AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 Ora Innovations, Inc. | EFB |
| Oct 22, 1998 | K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE Dentalez Group | EFB |
| Oct 8, 1998 | K980585 | MILLENNIUM Biolase Technology, Inc. | EFB |
| Sep 2, 1998 | K982050 | MODEL MS-2 HANDPIECE Parkell, Inc. | EFB |
| Aug 11, 1998 | K981869 | PRO-FLEX DISPOSABLE PROPHY ANGLE Professional Dental Mfg., Inc. | EFB |
| Jun 22, 1998 | K981990 | MRS-400, MAXI 400, MRSL-400, MAXI 400L D.B.I. America Corp. | EFB |
| Jun 5, 1998 | K980162 | MACH-SIGMA HANDPIECE, ULTRAPUSH Nsk Nakanishi, Inc., JP | EFB |
| Mar 13, 1998 | K974670 | ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE Athena Technology, Inc. | EFB |
| Mar 11, 1998 | K974671 | ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR Athena Technology, Inc. | EFB |
| Dec 19, 1997 | K973876 | PROPHYFLEX 2, MODEL 2012 Kavo America | EFB |
| Sep 22, 1997 | K972436 | T1 LINE DENTAL HANDPIECES Siemens AG | EFB |
| Sep 10, 1997 | K972376 | IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE Glenwood, LLC | EFB |
| Sep 10, 1997 | K972375 | IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE Glenwood, LLC | EFB |
| Jun 20, 1997 | K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION Nsk Nakanishi, Inc., JP | EFB |
| May 6, 1997 | K970104 | SANI-SHIELD Dw Industries, Inc. | EFB |
| Mar 31, 1997 | K963843 | ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT Micro Motors, Inc. | EFB |
| Jan 17, 1997 | K961275 | SIRIUS 10, 10L, 40, 40L Micro-Mega Societe Anonyme, FR | EFB |
| Jan 8, 1997 | K961235 | SIRIUS 180, 180L, 230, 230L Micro-Mega Societe Anonyme, FR | EFB |
| Oct 24, 1996 | K963664 | DENTAL HANDPIECE AND ACCESSORY Filmtech, Inc. | EFB |
| Oct 18, 1996 | K962877 | MIDWEST 300 SE Midwest Dental Products Corp. | EFB |
| Oct 11, 1996 | K963050 | TRADITION P, PUSH BUTTON HANDPIECE Midwest Dental Products Corp. | EFB |
| Sep 24, 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 Nsk Nakanishi, Inc., JP | EFB |
| Sep 11, 1996 | K962543 | ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU Nsk Nakanishi, Inc., JP | EFB |
| Aug 6, 1996 | K952927 | IMPACT AIR 45 4-HOLE Palisades Pharmaceutics, Inc. | EFB |
| Apr 26, 1996 | K961076 | MM 324 Micro-Mega Societe Anonyme, FR | EFB |
| Apr 23, 1996 | K961163 | LARES RESEARCH AS-1 LOWSPEED HANDPIECE Lares Research, Inc. | EFB |
| Mar 28, 1996 | K960541 | LYNX DPA DISPOSABLE PROPHY ANGLE Mti Precision Products | EFB |
| Mar 5, 1996 | K955655 | MIDWEST ONE Midwest Dental Products Corp. | EFB |
| Feb 21, 1996 | K960352 | ALLRAP/SLIP-N-GRIP Dental Disposables Intl., Inc. | EFB |
| Feb 8, 1996 | K955654 | SHORTSTOP DISPOSABLE PROPHY ANGLE Spintech, Inc. | EFB |
| Jan 29, 1996 | K945256 | MTC 7707 HIGH SPEED AIR TURBINE Mtc Industries and Research, Ltd., IL | EFB |
| Jan 16, 1996 | K954722 | MICRO-DISPENSER 7000 & MICRODISPENSER 8000 NOUVAG AG | EFB |
| Jan 4, 1996 | K954991 | PHASE CHANGE DENTAL LUBRICANT Phase Change | EFB |
| Nov 8, 1995 | K954012 | DISPOSABLE PROPHY HANDPIECE Denticator Intl., Inc. | EFB |
| Oct 5, 1995 | K945734 | W&H ROTO QUICK COUPLINGS A-Dec, Inc. | EFB |
| Oct 5, 1995 | K944719 | W&H 100 SERIES LOW SPEED A-Dec, Inc. | EFB |
| Oct 5, 1995 | K944718 | W&H 900 INCOLIGHT LT HANDPIECE A-Dec, Inc. | EFB |
| Aug 28, 1995 | K944713 | W&H MICRO AIR MOTOR LT25 A-Dec, Inc. | EFB |
| Aug 25, 1995 | K944714 | W&H CORSAIR SCALER A-Dec, Inc. | EFB |
| Aug 25, 1995 | K944712 | W&H MICRO MOTOR E25 (WITHOUT LIGHT) A-Dec, Inc. | EFB |
| Aug 25, 1995 | K944711 | W&H AIR MOTOR A25 A-Dec, Inc. | EFB |
| Aug 15, 1995 | K932333 | PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR Gull Laboratories, Inc. | EFB |
| Jun 8, 1995 | K944709 | W&H 896 TOP LIGH HIGHSPEED A-Dec, Inc. | EFB |
| Jun 2, 1995 | K944717 | W&H 798 TOP AIR TURBINE TRIPLE SPRAY A-Dec, Inc. | EFB |
| Jun 2, 1995 | K944716 | W&H 796 TOP AIR TURBINE MINI-HEAD A-Dec, Inc. | EFB |
| Jun 2, 1995 | K944715 | W&H 795 TOP AIR TURBINE SINGLE SPRAY A-Dec, Inc. | EFB |
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