Product code EFA
- Device name
- Handpiece, Belt And/Or Gear Driven, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4200
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020-08-25 |
| K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | 2017-03-17 |
| K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | 2015-04-09 |
| K101172 | RDT3 HANDPIECE HEAD MODEL RDT3 | Redent Nova, Ltd. | 2010-07-27 |
| K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | Anthogyr | 2010-03-03 |
| K092446 | INTRA LUX HEAD 3 LDSY | Kaltenbach & Voigt GmbH & Co. | 2009-11-03 |
| K090055 | LOW & HIGH SPEED KIT | Dpm USA Corp. | 2009-10-27 |
| K092412 | STRONG IMPLANT HANDPIECES | Saeshin Precision Co., Ltd. | 2009-09-03 |
| K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | Anthogyr | 2009-05-22 |
| K070084 | MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL | Est. Anthogyr | 2007-03-08 |
| K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | J. Morita USA, Inc. | 2006-08-25 |
| K061581 | EXCEL HIGH SPEED DENTAL HANDPIECE | Orthosource, Inc. | 2006-08-16 |
| K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | Anthogyr | 2004-06-30 |
| K013185 | TCM ENDO III | NOUVAG AG | 2001-11-28 |
| K002709 | RACE ENDODONTIC FILE | Amc General, Inc. | 2000-11-17 |
| K973062 | TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE | Medidenta Intl., Inc. | 1997-10-09 |
| K971603 | STERILE SUREFLEX FILES AND INSTRUMENTS | Dentsply Intl. | 1997-06-04 |
| K971606 | STERILE FLEXOFILE FILES AND INSTRUMENTS | Dentsply Intl. | 1997-06-03 |
| K965238 | T1 CONTROL HIGH SPEED DENTAL HANDPIECE | Siemens AG | 1997-03-19 |
| K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS | Dentalez Group | 1996-03-28 |
| K960507 | STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES | Dentalez Group | 1996-03-28 |
| K960719 | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE | Dentalez Group | 1996-03-28 |
| K953865 | SPACELINE FEEL 21 | J. Morita USA, Inc. | 1996-03-20 |
| K873147 | USI DENTAL POLISHER. A/G-20 | Cranston Ind., Inc. | 1987-10-14 |
| K800163 | VIMEDIC SYSTEM TM | Medical Systems Group of Viskay, Inc. | 1980-02-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D7166640081 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640211 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640201 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640191 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640181 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640171 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640161 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640151 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640141 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640131 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640121 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640111 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640101 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640091 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640071 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640061 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640051 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640041 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640031 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640021 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640011 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| D7166640221 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | 2022-10-27 |
| 10732224003365 | Twist Prophy Angles Disposable Flat Brush | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224003358 | Twist™ Disposable Prophy Angles Brush | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224003341 | Twist Prophy Angles Disposable Cup | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224003334 | Twist™ Disposable Prophy Angles | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10304040040253 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-11 |
| 10304040040246 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-11 |
| D742DELF2010 | Delfin | INTRA-LOCK INTERNATIONAL, INC. | 2017-02-08 |
| D742DELF2080 | Delfin | INTRA-LOCK INTERNATIONAL, INC. | 2017-02-08 |