EFA · Handpiece, Belt And/Or Gear Driven, Dental
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | EFA |
|---|---|
| Device Name | Handpiece, Belt And/Or Gear Driven, Dental |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
Classification Rationale
Class I.
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | Aug 25, 2020 | SESE |
| K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | Mar 17, 2017 | SESE |
| K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | Apr 9, 2015 | SESE |
| K101172 | RDT3 HANDPIECE HEAD MODEL RDT3 | Redent Nova, Ltd. | Jul 27, 2010 | SESE |
| K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | Anthogyr | Mar 3, 2010 | SESE |
| K092446 | INTRA LUX HEAD 3 LDSY | Kaltenbach & Voigt GmbH & Co. | Nov 3, 2009 | SESE |
| K090055 | LOW & HIGH SPEED KIT | Dpm USA Corp. | Oct 27, 2009 | SESE |
| K092412 | STRONG IMPLANT HANDPIECES | Saeshin Precision Co., Ltd. | Sep 3, 2009 | SESE |
| K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | Anthogyr | May 22, 2009 | SESE |
| K070084 | MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL | Est. Anthogyr | Mar 8, 2007 | SESE |
| K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | J. Morita USA, Inc. | Aug 25, 2006 | SESE |
| K061581 | EXCEL HIGH SPEED DENTAL HANDPIECE | Orthosource, Inc. | Aug 16, 2006 | SESE |
| K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | Anthogyr | Jun 30, 2004 | SESE |
| K013185 | TCM ENDO III | NOUVAG AG | Nov 28, 2001 | SESE |
| K002709 | RACE ENDODONTIC FILE | Amc General, Inc. | Nov 17, 2000 | SESE |
| K973062 | TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE | Medidenta Intl., Inc. | Oct 9, 1997 | SESE |
| K971603 | STERILE SUREFLEX FILES AND INSTRUMENTS | Dentsply Intl. | Jun 4, 1997 | SESE |
| K971606 | STERILE FLEXOFILE FILES AND INSTRUMENTS | Dentsply Intl. | Jun 3, 1997 | SESE |
| K965238 | T1 CONTROL HIGH SPEED DENTAL HANDPIECE | Siemens AG | Mar 19, 1997 | SESE |
| K960719 | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE | Dentalez Group | Mar 28, 1996 | SESE |
Top Applicants
- Anthogyr — 3 clearances
- Dentalez Group — 3 clearances
- Dentsply Intl. — 2 clearances
- J. Morita USA, Inc. — 2 clearances
- Kaltenbach & Voigt GmbH — 2 clearances
