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 28, 2014 | K141221 | LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR Lares Research, Inc. | EFB |
| Oct 24, 2014 | K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES Codent Technical Industry Co., Ltd., TW | EFB |
| May 30, 2014 | K131319 | T1/T2/T3 TURBINE FAMILY Sirona Dental Systems GmbH, DE | EFB |
| Apr 11, 2014 | K132478 | AIR-FLOW HANDY 3.0 E.M.S Electro Medical Systems S.A | EFB |
| Mar 28, 2014 | K133170 | QUICK JET M Micron Corp., JP | EFB |
| Feb 24, 2014 | K132480 | AIR-FLOW HANDY 3.0 PERIO E.M.S Electro Medical Systems S.A | EFB |
| Sep 27, 2013 | K130560 | MASTERTORQUE LUX 8900 L Kaltenbach & Voigt GmbH, DE | EFB |
| Sep 25, 2013 | K130455 | 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES Dentalez Group, Stardental Division | EFB |
| Aug 12, 2013 | K131014 | PANA SPRAY PLUS Nsk America Corp. | EFB |
| Jun 29, 2012 | K120218 | TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) Palm Beach Dental Supply D/B/A Tek USA | EFB |
| Jun 20, 2012 | K112024 | TI-MAX X450 Nakanishi, Inc. | EFB |
| Apr 5, 2012 | K113674 | SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT Handpiece Headquarters, Inc. - Hpr, Inc. | EFB |
| Mar 5, 2012 | K113655 | TI-MAX X TURBINE Nakanishi, Inc. | EFB |
| Feb 23, 2012 | K113222 | ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE Nakamura Dental Handpiece Mfg. Co., Ltd., JP | EFB |
| Feb 8, 2012 | K111249 | ORTHOSLENDERIZER Orthomatics, Inc. | EFB |
| Feb 7, 2012 | K112673 | PROPHY-MATE NEO Nakanishi, Inc. | EFB |
| Jan 23, 2012 | K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES Dentalez, Inc. | EFB |
| Dec 16, 2011 | K112869 | EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 Beyes Dental Canada, Inc. | EFB |
| Dec 16, 2011 | K112623 | AIRLIGHT DENTAL HANDPIECE Beyes Dental Canada, Inc. | EFB |
| Dec 8, 2011 | K110379 | AIR-N-GO Satelec | EFB |
| Apr 27, 2011 | K102517 | TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS Thunder Tiger Corp., TW | EFB |
| Dec 3, 2010 | K100731 | BOSWORTH AIR POLISHER Harry J. Bosworth Co. | EFB |
| Sep 9, 2010 | K101551 | PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M Delma Medical Instrument (Guangzhou) Co., Ltd. | EFB |
| Aug 20, 2010 | K101717 | DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING Aerobine, Inc. | EFB |
| Aug 12, 2010 | K100389 | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT Handpiece Headquarters | EFB |
| Jun 3, 2010 | K100833 | SYLE SMARTIP Osspray, Ltd. | EFB |
| Apr 22, 2010 | K093971 | DENTAL HANDPIECE North West Medical Instrument (Group) Co., Ltd., CN | EFB |
| Apr 5, 2010 | K093341 | CENTURY MODEL 105C Sybron Dental Specialties, Inc. | EFB |
| Jan 14, 2010 | K092933 | SAF (SELF ADJUSTING FILE) Redent-Nova , Ltd. | EFB |
| Dec 28, 2009 | K093072 | STARCARE HANDPIECE MAINTENANCE UNIT Dentalez, Inc. | EFB |
| Dec 16, 2009 | K093084 | ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP Rolence Ent., Inc., TW | EFB |
| Oct 20, 2009 | K092289 | EMS AIR-FLOW HANDY PERIO E.M.S Electro Medical Systems S.A | EFB |
| Oct 16, 2009 | K091065 | AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 J. Morita USA, Inc. | EFB |
| Jun 30, 2009 | K090548 | CONTRA-ANGLE HANDPIECE KOMET OS30 W&H Dentalwerk Buermoos GmbH, AT | EFB |
| Feb 27, 2009 | K090369 | PRODRIVE LINE OF DENTAL HANDPIECES Prodrive Systems, Inc. | EFB |
| Feb 23, 2009 | K083101 | PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES Sable Industries, Inc. | EFB |
| Feb 18, 2009 | K082791 | EMS AIR-FLOW MASTER E.M.S Electro Medical Systems S.A | EFB |
| Jan 21, 2009 | K081811 | CARE3 PLUS Nakanishi, Inc. | EFB |
| Jan 15, 2009 | K082716 | A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 A-Dec, Inc. | EFB |
| Jan 7, 2009 | K082827 | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT A-Dec, Inc. | EFB |
| Sep 11, 2008 | K080682 | HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE Handpiece Headquarters, Inc. - Hpr, Inc. | EFB |
| Sep 3, 2008 | K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS Sybron Dental Specialties, Inc. | EFB |
| Mar 20, 2008 | K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE Nakamura Magnifier Co., Ltd. | EFB |
| Feb 7, 2008 | K080240 | CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE Promident, LLC | EFB |
| Feb 4, 2008 | K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT Scican , Ltd., CA | EFB |
| Jan 28, 2008 | K072989 | AXIS SYSTEM Dentsply Intl., Inc. | EFB |
| Jan 25, 2008 | K072754 | AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE Axenic Dental, Inc. | EFB |
| Dec 14, 2007 | K073284 | AIR-FLOW MASTER STANDARD (Ems Sa) Electro Medical Systems | EFB |
| Dec 7, 2007 | K073353 | DO-ALL DENTAL HANDPIECE LUBRICANT Prodrive Systems, Inc. | EFB |
| Nov 14, 2007 | K072554 | ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES Sable Industries, Inc. | EFB |
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