EJBClass I

Handle, Instrument, Dental

Dental · 21 CFR 872.4565

MDR events39All time

Recalls1All time

Registered firms271Currently listed

510(k) clearances8All time

Recent MDR events

39 adverse event reports on file

DENTAL INSTRUMENTMay 14, 2021
MalfunctionBiomet 3i0001038806-2021-00805
BRASSELER DENTAL HANDPIECEFeb 5, 2019
InjuryBrasseler Usa Dental, Llc.MW5083723
CS SOLID HDL SERR W/RULEFeb 11, 2016
MalfunctionIntegra York, Pa Inc.2523190-2016-00012
OSSEOCISION TM MICROMOTOR WITH CORDJun 25, 2015
Nsk America Corp/nsk Dental Llc0001038806-2015-00704
ACETABULAR REAMER SHAFTAug 27, 2014
MalfunctionGreatbatch Sa9614497-2014-00206
ACETABULAR REAMER SHAFTAug 27, 2014
MalfunctionGreatbatch Medical Sa9614497-2014-00207
HU-FRIEDY #23/UNC 15 EXPRO, #7 HANDLEJul 19, 2013
OtherHu-friedy Mfg. Co., Llc1416605-2013-00002
AEZ LONG HANDLE MINI PIN & LIGATURE CUTTERFeb 6, 2013
MalfunctionOrmco Corporation2016150-2013-00002
HU-FRIEDY BRACKET REMOVERJun 11, 2012
Other1416605-2012-00002
MINIATURE PIN & LIGATURE CUTTERAug 17, 2011
MalfunctionGac International2086211-2011-00005

Event type breakdown

Malfunction31

Other4

Injury3

Unspecified1

Most-reported manufacturers

Gac International16 Dentsply Gac5 Unspecified2 Gac Intl2 Biomet 3i1 Brasseler Usa Dental, Llc.1 Dental Instruments1 Dentalez Group1

Recalls

1 recall events for this product code

Biomet 3i, Inc.
TerminatedSep 16, 2008
Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.
The drill malfunctions while in use. The drill has been observed to become lodged in the handle.
Z-2199-2008 · View FDA record ↗

Registered firms

271 firms currently registered for this product code

510(k) clearances

8 clearances for this product code