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.
Cleared Devices (25)
| 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 |
| K960507 | STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES | Dentalez Group | Mar 28, 1996 | SESE |
| K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS | Dentalez Group | Mar 28, 1996 | SESE |
| K953865 | SPACELINE FEEL 21 | J. Morita USA, Inc. | Mar 20, 1996 | SESE |
| K873147 | USI DENTAL POLISHER. A/G-20 | Cranston Ind., Inc. | Oct 14, 1987 | SESE |
| K800163 | VIMEDIC SYSTEM TM | Medical Systems Group of Viskay, Inc. | Feb 5, 1980 | SESE |
Top Applicants
- Dentalez Group — 3 clearances
- Anthogyr — 3 clearances
- Kaltenbach & Voigt GmbH — 2 clearances
- J. Morita USA, Inc. — 2 clearances
- Dentsply Intl. — 2 clearances
