EFA · Class I · 21 CFR 872.4200

FDA Product Code EFA: Handpiece, Belt And/or Gear Driven, Dental

Leading manufacturers include Dentalez Group, Dentsply Intl. and J. Morita USA, Inc..

25
Total
25
Cleared
92d
Avg days
1980
Since

FDA 510(k) Cleared Handpiece, Belt And/or Gear Driven, Dental Devices (Product Code EFA)

25 devices
1–24 of 25
Cleared Aug 25, 2020
Dental Handpiece
K192809
Micro-Nx Co., Ltd.
Dental · 329d
Cleared Mar 17, 2017
SMARTmatic
K163239
Kaltenbach & Voigt GmbH
Dental · 119d
Cleared Apr 09, 2015
MASTERmatic LUX
K143465
Kaltenbach & Voigt GmbH
Dental · 126d
Cleared Sep 03, 2009
STRONG IMPLANT HANDPIECES
K092412
Saeshin Precision Co., Ltd.
Dental · 28d
Cleared Mar 08, 2007
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
K070084
Est. Anthogyr
Dental · 58d
Cleared Aug 25, 2006
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)
K061701
J. Morita USA, Inc.
Dental · 70d
Cleared Aug 16, 2006
EXCEL HIGH SPEED DENTAL HANDPIECE
K061581
Orthosource, Inc.
Dental · 70d
Cleared Oct 09, 1997
TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE
K973062
Medidenta Intl., Inc.
Dental · 52d
Cleared Jun 04, 1997
STERILE SUREFLEX FILES AND INSTRUMENTS
K971603
Dentsply Intl.
Dental · 34d
Cleared Jun 03, 1997
STERILE FLEXOFILE FILES AND INSTRUMENTS
K971606
Dentsply Intl.
Dental · 33d
Cleared Mar 19, 1997
T1 CONTROL HIGH SPEED DENTAL HANDPIECE
K965238
Siemens AG
Dental · 78d
Cleared Mar 28, 1996
STAR TITAN SERIES MOTORS & ATTACHMENTS
K960260
Dentalez Group
Dental · 70d
Cleared Mar 28, 1996
STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES
K960507
Dentalez Group
Dental · 52d
Cleared Mar 28, 1996
STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE
K960719
Dentalez Group
Dental · 36d
Cleared Mar 20, 1996
SPACELINE FEEL 21
K953865
J. Morita USA, Inc.
Dental · 216d

About Product Code EFA - Regulatory Context