EBG · Class II · 21 CFR 872.3770

FDA Product Code EBG: Crown And Bridge, Temporary, Resin

Leading manufacturers include GC America, Inc., Ivoclar Vivadent, Inc. and Sybron Dental Specialties, Inc..

189
Total
189
Cleared
118d
Avg days
1977
Since
189 devices
97–120 of 189
Cleared Mar 15, 2002
BELLEGLASS HP MODELING GEL
K020178
Kerr Dental Materials Center
Dental · 56d
Cleared Mar 04, 2002
TEMPORARY CROWN AND BRIDGE MATERIAL
K020157
J. Morita USA, Inc.
Dental · 46d
Cleared Feb 22, 2002
TEMPHASE
K020092
Kerr Dental Materials Center
Dental · 43d
Cleared Feb 04, 2002
TEMPFIL
K013895
Sybron Dental Specialties, Inc.
Dental · 73d
Cleared Jan 24, 2002
LUXATEMP/LUXATEMP SOLAR/INSTATEMP
K013674
Dmg USA, Inc.
Dental · 78d
Cleared Sep 06, 2001
LC TEMPORARY FILLING
K012360
Parkell, Inc.
Dental · 43d
Cleared Feb 14, 2001
LC PROVIFILL
K010012
S & C Polymer GmbH
Dental · 43d
Cleared Jan 16, 2001
PATTERN RESIN
K003817
GC America, Inc.
Dental · 36d
Cleared Dec 04, 2000
FERMIT PLUS
K003374
Ivoclar North America, Inc.
Dental · 35d
Cleared Dec 04, 2000
FERMIT N PLUS
K003377
Ivoclar North America, Inc.
Dental · 35d
Cleared Aug 10, 2000
PROTEMP H
K002364
Espe Dental AG
Dental · 7d
Cleared Jun 09, 2000
3M QUIK TEMP TEMPORIZATION MATERIAL
K001114
3M Company
Dental · 64d
Cleared Apr 14, 2000
EZ CONNECT
K000346
Kerr Dental Materials Center
Dental · 71d
Cleared Apr 05, 2000
LUXAFORM
K000951
Dmg USA, Inc.
Dental · 13d
Cleared Feb 16, 2000
TEMPOFIT, MODEL 02693
K994012
Detax GmbH & Co. KG
Dental · 82d
Cleared Jun 23, 1999
JELTEMP
K991564
J.F. Jelenko & Co., Inc.
Dental · 49d
Cleared May 21, 1999
SMARTEMP
K991270
Parkell, Inc.
Dental · 38d
Cleared Oct 28, 1998
HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K980799
Cosmedent, Inc.
Dental · 240d
Cleared Sep 30, 1998
TEMPFIL F - 2
K982459
Sybron Dental Specialties, Inc.
Dental · 77d
Cleared Dec 17, 1997
DENT-TEMP ACRYLIC
K972198
Health-Dent Intl., Inc.
Dental · 189d
Cleared Feb 27, 1997
3M QUIKPLUS SYSTEM
K970168
3M Company
Dental · 42d
Cleared Feb 10, 1997
TEMPFIL C&B
K964981
Sybron Dental Specialties, Inc.
Dental · 60d
Cleared Feb 04, 1997
TCB TEMPORARY CROWN AND BRIDGE MATERIAL
K964691
Scican
Dental · 74d
Cleared Nov 19, 1996
TEMPFIL F
K963786
Sybron Dental Specialties, Inc.
Dental · 60d