Handpiece, Belt And/Or Gear Driven, Dental
Regulation 872.4200
0510(k)s in 12 months (25 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in EFA
| Company | 510(k)s | Recalls |
|---|---|---|
| Anthogyr | 3 | 0 |
| Dentalez Group | 3 | 0 |
| Kaltenbach & Voigt GmbH | 3 | 0 |
| Dentsply Intl. | 2 | 0 |
| J. Morita USA, Inc. | 2 | 0 |
| Amc General, Inc. | 1 | 0 |
| Cranston Ind., Inc. | 1 | 0 |
| Dental EZ Group Star Dental Division | 0 | 1 |
| Dental EZ Stardental Division | 0 | 1 |
| Dpm USA Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2020 | K192809 | Dental Handpiece Micro-Nx Co., Ltd., KR | EFA |
| Mar 17, 2017 | K163239 | SMARTmatic Kaltenbach & Voigt GmbH, DE | EFA |
| Apr 9, 2015 | K143465 | MASTERmatic LUX Kaltenbach & Voigt GmbH, DE | EFA |
| Jul 27, 2010 | K101172 | RDT3 HANDPIECE HEAD MODEL RDT3 Redent Nova, Ltd. | EFA |
| Mar 3, 2010 | K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE Anthogyr, FR | EFA |
| Nov 3, 2009 | K092446 | INTRA LUX HEAD 3 LDSY Kaltenbach & Voigt GmbH & Co. | EFA |
| Oct 27, 2009 | K090055 | LOW & HIGH SPEED KIT Dpm USA Corp. | EFA |
| Sep 3, 2009 | K092412 | STRONG IMPLANT HANDPIECES Saeshin Precision Co., Ltd., KR | EFA |
| May 22, 2009 | K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES Anthogyr, FR | EFA |
| Mar 8, 2007 | K070084 | MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL Est. Anthogyr, FR | EFA |
| Aug 25, 2006 | K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) J. Morita USA, Inc. | EFA |
| Aug 16, 2006 | K061581 | EXCEL HIGH SPEED DENTAL HANDPIECE Orthosource, Inc. | EFA |
| Jun 30, 2004 | K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES Anthogyr, FR | EFA |
| Nov 28, 2001 | K013185 | TCM ENDO III NOUVAG AG | EFA |
| Nov 17, 2000 | K002709 | RACE ENDODONTIC FILE Amc General, Inc. | EFA |
| Oct 9, 1997 | K973062 | TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE Medidenta Intl., Inc. | EFA |
| Jun 4, 1997 | K971603 | STERILE SUREFLEX FILES AND INSTRUMENTS Dentsply Intl. | EFA |
| Jun 3, 1997 | K971606 | STERILE FLEXOFILE FILES AND INSTRUMENTS Dentsply Intl. | EFA |
| Mar 19, 1997 | K965238 | T1 CONTROL HIGH SPEED DENTAL HANDPIECE Siemens AG | EFA |
| Mar 28, 1996 | K960719 | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE Dentalez Group | EFA |
| Mar 28, 1996 | K960507 | STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES Dentalez Group | EFA |
| Mar 28, 1996 | K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS Dentalez Group | EFA |
| Mar 20, 1996 | K953865 | SPACELINE FEEL 21 J. Morita USA, Inc. | EFA |
| Oct 14, 1987 | K873147 | USI DENTAL POLISHER. A/G-20 Cranston Ind., Inc. | EFA |
| Feb 5, 1980 | K800163 | VIMEDIC SYSTEM TM Medical Systems Group of Viskay, Inc. | EFA |
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