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 |
|---|---|---|---|
| Oct 12, 2007 | K071561 | HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D Beijing North Pole Dental Handpiece Co., Ltd., CN | EFB |
| Sep 13, 2007 | K071891 | STATIS DENTAL HANDPIECES Scican , Ltd., CA | EFB |
| Sep 10, 2007 | K071965 | I-SURGE Satelec | EFB |
| Jul 5, 2007 | K070663 | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT A-Dec, Inc. | EFB |
| Jun 15, 2007 | K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 Dentalez, Inc. | EFB |
| May 31, 2007 | K070074 | LUBRINA, MODEL HIM-1 J. Morita USA, Inc. | EFB |
| Feb 5, 2007 | K070297 | CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT Dental Air Solutions of Nc, Inc. | EFB |
| Feb 2, 2007 | K070001 | MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE Mti Precision Products | EFB |
| Jan 25, 2007 | K070155 | INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC Osseo Scientific, LLC | EFB |
| Dec 14, 2006 | K062947 | HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES Peng Lim Enterprise Co., Ltd., TW | EFB |
| Nov 28, 2006 | K062812 | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N Thunder Tiger Corp., TW | EFB |
| Nov 2, 2006 | K062740 | JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU Jindell Medical Instruments Co., Ltd., TW | EFB |
| Oct 26, 2006 | K063110 | CST61 HIGH SPEED TURBINE HANDPIECE Shanghai Dental Instrument Factory | EFB |
| Oct 19, 2006 | K062418 | K-SPRAY, MODEL 085-2715 Scican, CA | EFB |
| Aug 4, 2006 | K062219 | PRODRIVE SYSTEMS REPLACEMENT TURBINE Prodrive Systems, Inc., CA | EFB |
| Mar 29, 2006 | K053368 | INTERPROXIMAL REDUCTION SYSTEM Dentsply International | EFB |
| Jan 20, 2006 | K052822 | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 Thunder Tiger Corp., TW | EFB |
| Dec 20, 2005 | K052700 | PANA-SPRAY Nsk America Corp. | EFB |
| Oct 3, 2005 | K051872 | MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 Mk-Dent GmbH, DE | EFB |
| Mar 21, 2005 | K043497 | AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV J. Morita USA, Inc. | EFB |
| Feb 16, 2005 | K043498 | TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE J. Morita USA, Inc. | EFB |
| Dec 17, 2004 | K042787 | IS 40 MICROMOTOR Satelec | EFB |
| Oct 22, 2004 | K041755 | CROMAX HIGH SPEED TURBINE HANDPIECE J.R. Medical Technologies, Inc. | EFB |
| Jun 16, 2004 | K041141 | DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 Dentsply Intl. | EFB |
| Feb 23, 2004 | K033812 | SIROAIR L AIR SCALER Sirona Dental Systems GmbH | EFB |
| Feb 6, 2004 | K033213 | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS Codent Technical Industry Co., Ltd., TW | EFB |
| Oct 17, 2003 | K032395 | PROPHY-MATE Nakanishi, Inc., JP | EFB |
| Oct 2, 2003 | K032234 | MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K Mk-Dent GmbH, DE | EFB |
| Aug 1, 2003 | K031851 | DENTISEPTIC HPC Bethel, Inc. | EFB |
| Jul 15, 2003 | K031145 | ESTYLUS ELECTRIC MOTOR SYSTEM Dentsply Intl. | EFB |
| Jul 9, 2003 | K031868 | PROPHYPEARLS Kavo America | EFB |
| Oct 22, 2002 | K022535 | MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 Microtech | EFB |
| Jul 25, 2002 | K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE Electro Medical Systems SA | EFB |
| Jun 26, 2002 | K012308 | KAVO QUATTROCARE Kavo America | EFB |
| Nov 8, 2001 | K012720 | TULSA CONTRA ANGLES Dentsply Intl. | EFB |
| Oct 5, 2001 | K010127 | W & H ASSISTINA A-Dec, Inc. | EFB |
| Jan 9, 2001 | K003518 | RAPIDD HIGHSPEED DENTAL HANDPIECE Dentsply Intl. | EFB |
| Dec 14, 2000 | K000834 | CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO Castellini S.P.A., IT | EFB |
| Oct 5, 2000 | K000848 | TDK HANDPIECES Orasystems | EFB |
| Sep 27, 2000 | K000847 | ORALUBE Orasystems | EFB |
| May 11, 2000 | K000710 | MD 10, SEM, SM 12, CBM NOUVAG AG, DE | EFB |
| May 3, 2000 | K000547 | ATR TECNIKA Advanced Technology Research (A.T.R.) S.R.P., IT | EFB |
| Apr 4, 2000 | K000049 | SUNI MAX Satelec | EFB |
| Jan 11, 2000 | K993526 | SYNEA - LS LOW-SPEED HANDPIECE A-Dec, Inc. | EFB |
| Jan 11, 2000 | K971732 | DENTAL HANDPIECE Pauline M. Nicholls | EFB |
| Dec 15, 1999 | K991401 | ATR 3000, ATR 2000, IMPLANT-PRO Advanced Technology Research (A.T.R.) S.R.P. | EFB |
| Dec 2, 1999 | K991492 | LC COMPOSITE Harry J. Bosworth Co. | EFB |
| Oct 13, 1999 | K992380 | ENDO-EZE MOTOR AND HANDPIECE Ultradent Products, Inc. | EFB |
| Oct 7, 1999 | K991857 | AIRFLOW HANDY Electro Medical Systems, Inc. | EFB |
| Sep 10, 1999 | K992011 | SYNEA-HS HIGH SPEED-HANDPIECE A-Dec, Inc. | EFB |
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