FDA Product Code
FDA Product Code EFA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4200
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020-08-25 | Traditional | PDF ↗ |
| K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | 2017-03-17 | Traditional | PDF ↗ |
| K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | 2015-04-09 | Traditional | PDF ↗ |
| K101172 | RDT3 HANDPIECE HEAD MODEL RDT3 | Redent Nova, Ltd. | 2010-07-27 | Traditional | PDF ↗ |
| K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | Anthogyr | 2010-03-03 | Special | PDF ↗ |
| K092446 | INTRA LUX HEAD 3 LDSY | Kaltenbach & Voigt GmbH & Co. | 2009-11-03 | Traditional | PDF ↗ |
| K090055 | LOW & HIGH SPEED KIT | Dpm USA Corp. | 2009-10-27 | Traditional | PDF ↗ |
| K092412 | STRONG IMPLANT HANDPIECES | Saeshin Precision Co., Ltd. | 2009-09-03 | Traditional | PDF ↗ |
| K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | Anthogyr | 2009-05-22 | Special | PDF ↗ |
| K070084 | MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL | Est. Anthogyr | 2007-03-08 | Special | PDF ↗ |
| K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | J. Morita USA, Inc. | 2006-08-25 | Traditional | PDF ↗ |
| K061581 | EXCEL HIGH SPEED DENTAL HANDPIECE | Orthosource, Inc. | 2006-08-16 | Abbreviated | PDF ↗ |
| K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | Anthogyr | 2004-06-30 | Traditional | PDF ↗ |
| K013185 | TCM ENDO III | NOUVAG AG | 2001-11-28 | Traditional | PDF ↗ |
| K002709 | RACE ENDODONTIC FILE | Amc General, Inc. | 2000-11-17 | Traditional | PDF ↗ |
| K973062 | TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE | Medidenta Intl., Inc. | 1997-10-09 | Traditional | PDF ↗ |
| K971603 | STERILE SUREFLEX FILES AND INSTRUMENTS | Dentsply Intl. | 1997-06-04 | Traditional | PDF ↗ |
| K971606 | STERILE FLEXOFILE FILES AND INSTRUMENTS | Dentsply Intl. | 1997-06-03 | Traditional | PDF ↗ |
| K965238 | T1 CONTROL HIGH SPEED DENTAL HANDPIECE | Siemens AG | 1997-03-19 | Traditional | PDF ↗ |
| K960719 | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE | Dentalez Group | 1996-03-28 | Traditional | PDF ↗ |
| K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS | Dentalez Group | 1996-03-28 | Traditional | PDF ↗ |
| K960507 | STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES | Dentalez Group | 1996-03-28 | Traditional | PDF ↗ |
| K953865 | SPACELINE FEEL 21 | J. Morita USA, Inc. | 1996-03-20 | Traditional | PDF ↗ |
| K873147 | USI DENTAL POLISHER. A/G-20 | Cranston Ind., Inc. | 1987-10-14 | Traditional | PDF ↗ |
| K800163 | VIMEDIC SYSTEM TM | Medical Systems Group of Viskay, Inc. | 1980-02-05 | Traditional | PDF ↗ |
Product code EFA · Class I · Dental. Data: openFDA.