FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K002709 |
AMC GENERAL, INC. |
RACE ENDODONTIC FILE |
11/17/2000 |
K093894 |
ANTHOGYR |
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE |
03/03/2010 |
K040674 |
ANTHOGYR |
IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES |
06/30/2004 |
K090676 |
ANTHOGYR |
MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES |
05/22/2009 |
K960719 |
DENTALEZ GROUP |
STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE |
03/28/1996 |
K960507 |
DENTALEZ GROUP |
STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES |
03/28/1996 |
K960260 |
DENTALEZ GROUP |
STAR TITAN SERIES MOTORS & ATTACHMENTS |
03/28/1996 |
K971606 |
DENTSPLY INTL. |
STERILE FLEXOFILE FILES AND INSTRUMENTS |
06/03/1997 |
K971603 |
DENTSPLY INTL. |
STERILE SUREFLEX FILES AND INSTRUMENTS |
06/04/1997 |
K090055 |
DPM USA CORP. |
LOW & HIGH SPEED KIT |
10/27/2009 |
K070084 |
EST. ANTHOGYR |
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL |
03/08/2007 |
K061701 |
J. MORITA USA, INC. |
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) |
08/25/2006 |
K953865 |
J. MORITA USA, INC. |
SPACELINE FEEL 21 |
03/20/1996 |
K143465 |
Kaltenbach & Voigt Gmbh |
MASTERmatic LUX |
04/09/2015 |
K163239 |
Kaltenbach & Voigt GmbH |
SMARTmatic |
03/17/2017 |
K092446 |
KALTENBACH & VOIGT GMBH & CO. |
INTRA LUX HEAD 3 LDSY |
11/03/2009 |
K973062 |
MEDIDENTA INTL., INC. |
TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE |
10/09/1997 |
K192809 |
Micro-NX Co., Ltd. |
Dental Handpiece |
08/25/2020 |
K220577 |
Micro-NX Co., Ltd. |
Dental Handpiece, Model CA160, CA160L, and CA500L |
07/29/2022 |
K013185 |
NOUVAG AG |
TCM ENDO III |
11/28/2001 |
K061581 |
ORTHOSOURCE, INC. |
EXCEL HIGH SPEED DENTAL HANDPIECE |
08/16/2006 |
K101172 |
REDENT NOVA LTD |
RDT3 HANDPIECE HEAD MODEL RDT3 |
07/27/2010 |
K092412 |
SAESHIN PRECISION CO., LTD. |
STRONG IMPLANT HANDPIECES |
09/03/2009 |
K965238 |
SIEMENS AG |
T1 CONTROL HIGH SPEED DENTAL HANDPIECE |
03/19/1997 |