Atlas FDA

EFA

25 FDA 510(k) clearances · Product code

70 daysmedian time to decision
216 days90th percentile
25clearances measured

FDA profile

Official device name
Handpiece, Belt And/Or Gear Driven, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2001: 2 · 2003: 1 · 2004: 2 · 2008: 17 · 2018: 97 · 2019: 59
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Dental Handpiece (K192809)Micro-Nx Co., Ltd.2020-08-25
SMARTmatic (K163239)Kaltenbach & Voigt GmbH2017-03-17
MASTERmatic LUX (K143465)Kaltenbach & Voigt GmbH2015-04-09
RDT3 HANDPIECE HEAD MODEL RDT3 (K101172)Redent Nova, Ltd.2010-07-27
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE (K093894)Anthogyr2010-03-03
INTRA LUX HEAD 3 LDSY (K092446)Kaltenbach & Voigt GmbH & Co.2009-11-03
LOW & HIGH SPEED KIT (K090055)Dpm USA Corp.2009-10-27
STRONG IMPLANT HANDPIECES (K092412)Saeshin Precision Co., Ltd.2009-09-03
MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES (K090676)Anthogyr2009-05-22
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (K070084)Est. Anthogyr2007-03-08
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) (K061701)J. Morita USA, Inc.2006-08-25
EXCEL HIGH SPEED DENTAL HANDPIECE (K061581)Orthosource, Inc.2006-08-16
IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES (K040674)Anthogyr2004-06-30
TCM ENDO III (K013185)NOUVAG AG2001-11-28
RACE ENDODONTIC FILE (K002709)Amc General, Inc.2000-11-17
TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE (K973062)Medidenta Intl., Inc.1997-10-09
STERILE SUREFLEX FILES AND INSTRUMENTS (K971603)Dentsply Intl.1997-06-04
STERILE FLEXOFILE FILES AND INSTRUMENTS (K971606)Dentsply Intl.1997-06-03
T1 CONTROL HIGH SPEED DENTAL HANDPIECE (K965238)Siemens AG1997-03-19
STAR TITAN SERIES MOTORS & ATTACHMENTS (K960260)Dentalez Group1996-03-28
STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES (K960507)Dentalez Group1996-03-28
STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE (K960719)Dentalez Group1996-03-28
SPACELINE FEEL 21 (K953865)J. Morita USA, Inc.1996-03-20
USI DENTAL POLISHER. A/G-20 (K873147)Cranston Ind., Inc.1987-10-14
VIMEDIC SYSTEM TM (K800163)Medical Systems Group of Viskay, Inc.1980-02-05

Track EFA automatically

Every clearance here is in the API, with alerts when new ones post.