FDA Product Code
FDA Product Code EFB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4200
510(k) Clearances — 263 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071561 | HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D | Beijing North Pole Dental Handpiece Co., Ltd. | 2007-10-12 | Traditional | PDF ↗ |
| K071891 | STATIS DENTAL HANDPIECES | Scican , Ltd. | 2007-09-13 | Abbreviated | PDF ↗ |
| K071965 | I-SURGE | Satelec | 2007-09-10 | Traditional | PDF ↗ |
| 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. | 2007-07-05 | Abbreviated | PDF ↗ |
| K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 | Dentalez, Inc. | 2007-06-15 | Traditional | PDF ↗ |
| K070074 | LUBRINA, MODEL HIM-1 | J. Morita USA, Inc. | 2007-05-31 | Traditional | PDF ↗ |
| K070297 | CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT | Dental Air Solutions of Nc, Inc. | 2007-02-05 | Traditional | PDF ↗ |
| K070001 | MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE | Mti Precision Products | 2007-02-02 | Special | PDF ↗ |
| K070155 | INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC | Osseo Scientific, LLC | 2007-01-25 | Traditional | PDF ↗ |
| K062947 | HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES | Peng Lim Enterprise Co., Ltd. | 2006-12-14 | Traditional | PDF ↗ |
| K062812 | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N | Thunder Tiger Corp. | 2006-11-28 | Traditional | PDF ↗ |
| K062740 | JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU | Jindell Medical Instruments Co., Ltd. | 2006-11-02 | Traditional | PDF ↗ |
| K063110 | CST61 HIGH SPEED TURBINE HANDPIECE | Shanghai Dental Instrument Factory | 2006-10-26 | Traditional | PDF ↗ |
| K062418 | K-SPRAY, MODEL 085-2715 | Scican | 2006-10-19 | Traditional | PDF ↗ |
| K062219 | PRODRIVE SYSTEMS REPLACEMENT TURBINE | Prodrive Systems, Inc. | 2006-08-04 | Traditional | PDF ↗ |
| K053368 | INTERPROXIMAL REDUCTION SYSTEM | Dentsply International | 2006-03-29 | Traditional | PDF ↗ |
| K052822 | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 | Thunder Tiger Corp. | 2006-01-20 | Traditional | PDF ↗ |
| K052700 | PANA-SPRAY | Nsk America Corp. | 2005-12-20 | Traditional | PDF ↗ |
| K051872 | MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 | Mk-Dent GmbH | 2005-10-03 | Traditional | PDF ↗ |
| 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. | 2005-03-21 | Traditional | PDF ↗ |
| K043498 | TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE | J. Morita USA, Inc. | 2005-02-16 | Traditional | PDF ↗ |
| K042787 | IS 40 MICROMOTOR | Satelec | 2004-12-17 | Traditional | PDF ↗ |
| K041755 | CROMAX HIGH SPEED TURBINE HANDPIECE | J.R. Medical Technologies, Inc. | 2004-10-22 | Traditional | PDF ↗ |
| K041141 | DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 | Dentsply Intl. | 2004-06-16 | Traditional | PDF ↗ |
| K033812 | SIROAIR L AIR SCALER | Sirona Dental Systems GmbH | 2004-02-23 | Traditional | PDF ↗ |
| K033213 | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS | Codent Technical Industry Co., Ltd. | 2004-02-06 | Traditional | PDF ↗ |
| K032395 | PROPHY-MATE | Nakanishi, Inc. | 2003-10-17 | Traditional | PDF ↗ |
| K032234 | MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K | Mk-Dent GmbH | 2003-10-02 | Traditional | PDF ↗ |
| K031851 | DENTISEPTIC HPC | Bethel, Inc. | 2003-08-01 | Traditional | PDF ↗ |
| K031145 | ESTYLUS ELECTRIC MOTOR SYSTEM | Dentsply Intl. | 2003-07-15 | Traditional | PDF ↗ |
| K031868 | PROPHYPEARLS | Kavo America | 2003-07-09 | Special | PDF ↗ |
| K022535 | MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 | Microtech | 2002-10-22 | Traditional | PDF ↗ |
| K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE | Electro Medical Systems SA | 2002-07-25 | Special | PDF ↗ |
| K012308 | KAVO QUATTROCARE | Kavo America | 2002-06-26 | Traditional | PDF ↗ |
| K012720 | TULSA CONTRA ANGLES | Dentsply Intl. | 2001-11-08 | Traditional | PDF ↗ |
| K010127 | W & H ASSISTINA | A-Dec, Inc. | 2001-10-05 | Traditional | PDF ↗ |
| K003518 | RAPIDD HIGHSPEED DENTAL HANDPIECE | Dentsply Intl. | 2001-01-09 | Traditional | PDF ↗ |
| K000834 | CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO | Castellini S.P.A. | 2000-12-14 | Traditional | PDF ↗ |
| K000848 | TDK HANDPIECES | Orasystems | 2000-10-05 | Traditional | PDF ↗ |
| K000847 | ORALUBE | Orasystems | 2000-09-27 | Traditional | PDF ↗ |
| K000710 | MD 10, SEM, SM 12, CBM | NOUVAG AG | 2000-05-11 | Traditional | PDF ↗ |
| K000547 | ATR TECNIKA | Advanced Technology Research (A.T.R.) S.R.P. | 2000-05-03 | Traditional | PDF ↗ |
| K000049 | SUNI MAX | Satelec | 2000-04-04 | Traditional | PDF ↗ |
| K993526 | SYNEA - LS LOW-SPEED HANDPIECE | A-Dec, Inc. | 2000-01-11 | Traditional | PDF ↗ |
| K971732 | DENTAL HANDPIECE | Pauline M. Nicholls | 2000-01-11 | Traditional | PDF ↗ |
| K991401 | ATR 3000, ATR 2000, IMPLANT-PRO | Advanced Technology Research (A.T.R.) S.R.P. | 1999-12-15 | Traditional | PDF ↗ |
| K991492 | LC COMPOSITE | Harry J. Bosworth Co. | 1999-12-02 | Traditional | PDF ↗ |
| K992380 | ENDO-EZE MOTOR AND HANDPIECE | Ultradent Products, Inc. | 1999-10-13 | Traditional | PDF ↗ |
| K991857 | AIRFLOW HANDY | Electro Medical Systems, Inc. | 1999-10-07 | Traditional | PDF ↗ |
| K992011 | SYNEA-HS HIGH SPEED-HANDPIECE | A-Dec, Inc. | 1999-09-10 | Traditional | PDF ↗ |
| K991701 | MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) | Nsk Nakanishi, Inc. | 1999-08-10 | Traditional | PDF ↗ |
| K984244 | ORL-E-92 SURGICAL DRILL SYSTEM | Bien Air USA, Inc. | 1999-02-23 | Traditional | PDF ↗ |
| K981679 | TCM 3000 AND TCM ENDO | NOUVAG AG | 1999-02-09 | Traditional | PDF ↗ |
| 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. | 1998-12-10 | Traditional | PDF ↗ |
| K983168 | AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 | Ora Innovations, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE | Dentalez Group | 1998-10-22 | Traditional | PDF ↗ |
| K980585 | MILLENNIUM | Biolase Technology, Inc. | 1998-10-08 | Traditional | PDF ↗ |
| K982050 | MODEL MS-2 HANDPIECE | Parkell, Inc. | 1998-09-02 | Traditional | PDF ↗ |
| K981869 | PRO-FLEX DISPOSABLE PROPHY ANGLE | Professional Dental Mfg., Inc. | 1998-08-11 | Traditional | PDF ↗ |
| K981990 | MRS-400, MAXI 400, MRSL-400, MAXI 400L | D.B.I. America Corp. | 1998-06-22 | Traditional | PDF ↗ |
| K980162 | MACH-SIGMA HANDPIECE, ULTRAPUSH | Nsk Nakanishi, Inc. | 1998-06-05 | Traditional | PDF ↗ |
| 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. | 1998-03-13 | Traditional | PDF ↗ |
| K974671 | ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR | Athena Technology, Inc. | 1998-03-11 | Traditional | PDF ↗ |
| K973876 | PROPHYFLEX 2, MODEL 2012 | Kavo America | 1997-12-19 | Traditional | PDF ↗ |
| K972436 | T1 LINE DENTAL HANDPIECES | Siemens AG | 1997-09-22 | Traditional | PDF ↗ |
| K972376 | IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE | Glenwood, LLC | 1997-09-10 | Traditional | PDF ↗ |
| K972375 | IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE | Glenwood, LLC | 1997-09-10 | Traditional | PDF ↗ |
| K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION | Nsk Nakanishi, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K970104 | SANI-SHIELD | Dw Industries, Inc. | 1997-05-06 | Traditional | PDF ↗ |
| K963843 | ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT | Micro Motors, Inc. | 1997-03-31 | Traditional | PDF ↗ |
| K961275 | SIRIUS 10, 10L, 40, 40L | Micro-Mega Societe Anonyme | 1997-01-17 | Traditional | PDF ↗ |
| K961235 | SIRIUS 180, 180L, 230, 230L | Micro-Mega Societe Anonyme | 1997-01-08 | Traditional | PDF ↗ |
| K963664 | DENTAL HANDPIECE AND ACCESSORY | Filmtech, Inc. | 1996-10-24 | Traditional | PDF ↗ |
| K962877 | MIDWEST 300 SE | Midwest Dental Products Corp. | 1996-10-18 | Traditional | PDF ↗ |
| K963050 | TRADITION P, PUSH BUTTON HANDPIECE | Midwest Dental Products Corp. | 1996-10-11 | Traditional | PDF ↗ |
| K962542 | AIR MOTOR HANDPIECE TN-102 | Nsk Nakanishi, Inc. | 1996-09-24 | Traditional | PDF ↗ |
| K962543 | ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU | Nsk Nakanishi, Inc. | 1996-09-11 | Traditional | PDF ↗ |
| K952927 | IMPACT AIR 45 4-HOLE | Palisades Pharmaceutics, Inc. | 1996-08-06 | Traditional | PDF ↗ |
| K961076 | MM 324 | Micro-Mega Societe Anonyme | 1996-04-26 | Traditional | PDF ↗ |
| K961163 | LARES RESEARCH AS-1 LOWSPEED HANDPIECE | Lares Research, Inc. | 1996-04-23 | Traditional | PDF ↗ |
| K960541 | LYNX DPA DISPOSABLE PROPHY ANGLE | Mti Precision Products | 1996-03-28 | Traditional | PDF ↗ |
| K955655 | MIDWEST ONE | Midwest Dental Products Corp. | 1996-03-05 | Traditional | PDF ↗ |
| K960352 | ALLRAP/SLIP-N-GRIP | Dental Disposables Intl., Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K955654 | SHORTSTOP DISPOSABLE PROPHY ANGLE | Spintech, Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K945256 | MTC 7707 HIGH SPEED AIR TURBINE | Mtc Industries and Research, Ltd. | 1996-01-29 | Traditional | PDF ↗ |
| K954722 | MICRO-DISPENSER 7000 & MICRODISPENSER 8000 | NOUVAG AG | 1996-01-16 | Traditional | PDF ↗ |
| K954991 | PHASE CHANGE DENTAL LUBRICANT | Phase Change | 1996-01-04 | Traditional | PDF ↗ |
| K954012 | DISPOSABLE PROPHY HANDPIECE | Denticator Intl., Inc. | 1995-11-08 | Traditional | PDF ↗ |
| K945734 | W&H ROTO QUICK COUPLINGS | A-Dec, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K944719 | W&H 100 SERIES LOW SPEED | A-Dec, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K944718 | W&H 900 INCOLIGHT LT HANDPIECE | A-Dec, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K944713 | W&H MICRO AIR MOTOR LT25 | A-Dec, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K944714 | W&H CORSAIR SCALER | A-Dec, Inc. | 1995-08-25 | Traditional | PDF ↗ |
| K944712 | W&H MICRO MOTOR E25 (WITHOUT LIGHT) | A-Dec, Inc. | 1995-08-25 | Traditional | PDF ↗ |
| K944711 | W&H AIR MOTOR A25 | A-Dec, Inc. | 1995-08-25 | Traditional | PDF ↗ |
| K932333 | PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR | Gull Laboratories, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K944709 | W&H 896 TOP LIGH HIGHSPEED | A-Dec, Inc. | 1995-06-08 | Traditional | PDF ↗ |
| K944715 | W&H 795 TOP AIR TURBINE SINGLE SPRAY | A-Dec, Inc. | 1995-06-02 | Traditional | PDF ↗ |
| K944717 | W&H 798 TOP AIR TURBINE TRIPLE SPRAY | A-Dec, Inc. | 1995-06-02 | Traditional | PDF ↗ |
| K944716 | W&H 796 TOP AIR TURBINE MINI-HEAD | A-Dec, Inc. | 1995-06-02 | Traditional | PDF ↗ |
Product code EFB · Class I · Dental. Data: openFDA.