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
121–144 of 189
Cleared Jun 25, 1996
BOSWORTH TEMPORARY RESIN
K961199
Harry J. Bosworth Co.
Dental · 90d
Cleared May 24, 1996
BOSWORTH CH I
K961198
Harry J. Bosworth Co.
Dental · 58d
Cleared Apr 25, 1996
POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)
K954976
Healex Products, Inc.
Dental · 181d
Cleared Apr 18, 1996
PROV-KB
K960938
Silicon-Und Composite Spezialitaten GmbH
Dental · 41d
Cleared Feb 21, 1996
ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL
K960122
Wallace A. Erickson & Co.
Dental · 36d
Cleared Jan 02, 1996
BELLEGLASHP
K955331
Sybron Dental Specialties, Inc.
Dental · 43d
Cleared Feb 02, 1995
PROTEMP(R) GARANT
K950203
Espe GmbH & Co. Kg.
Dental · 15d
Cleared Dec 02, 1994
3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
K944981
3M Company
Dental · 56d
Cleared Oct 18, 1994
GC PATTERN RESIN
K942670
GC America, Inc.
Dental · 134d
Cleared Apr 13, 1994
STRUCTUR 2
K941124
Voco GmbH
Dental · 35d
Cleared Mar 04, 1994
GC TEMPRON
K935960
GC America, Inc.
Dental · 81d
Cleared Jan 26, 1994
3M TEMPORARY CROWN & BRIDGE MATERIAL
K935041
3M Company
Dental · 97d
Cleared Dec 10, 1993
DENTALON PLUS MODIFICATION
K934283
Heraeus Kulzer, Inc.
Dental · 101d
Cleared Dec 10, 1993
FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL
K934978
Ivoclar North America, Inc.
Dental · 52d
Cleared Aug 06, 1993
PALAVIT 55 AND DENTACOLOR CONNECTOR
K932034
Heraeus Kulzer, Inc.
Dental · 101d
Cleared Dec 24, 1992
ACUFEX ENDOFIX BUTTON
K922559
Acufex Microsurgical, Inc.
Dental · 209d
Cleared Feb 03, 1992
SEPTOPACK TEMPORARY FILLING
K915466
Specialites Septodont
Dental · 60d
Cleared Aug 13, 1990
DENTALON PLUS
K903317
Kulzer, Inc.
Dental · 19d
Cleared May 29, 1990
PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)
K901077
Scientific Pharmaceuticals, Inc.
Dental · 83d
Cleared Mar 28, 1990
PROTEMP II
K900436
Espe GmbH (Us)
Dental · 57d
Cleared Apr 17, 1989
UNIFAST LC
K890829
G-C Intl. Corp.
Dental · 55d
Cleared Mar 01, 1988
CAVIT-W
K875133
Espe GmbH (Us)
Dental · 77d
Cleared Feb 26, 1988
MAR BOND
K875145
Reliance Orthodontic Products, Inc.
Dental · 73d
Cleared Aug 16, 1985
INTEGRITY
K853052
Dentsply Intl.
Dental · 28d