LBH · Class II · 21 CFR 872.3260

FDA Product Code LBH: Varnish, Cavity

Leading manufacturers include Ultradent Products, Inc., Scientific Pharmaceuticals, Inc. and Pulpdent Corp..

138
Total
138
Cleared
127d
Avg days
1976
Since
138 devices
73–96 of 138
Cleared Nov 17, 1999
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
K992822
Dentsply Intl.
Dental · 86d
Cleared Oct 22, 1999
D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
K992629
Centrix, Inc.
Dental · 86d
Cleared Feb 12, 1999
SCI-PHARM DFV VARNISH
K982915
Scientific Pharmaceuticals, Inc.
Dental · 177d
Cleared Dec 17, 1998
SCI-PHARM DESENSITIZING VARNISH
K983305
Scientific Pharmaceuticals, Inc.
Dental · 87d
Cleared Dec 07, 1998
GREEN-OR DENTIN DESENSITIZER
K981972
Centrix, Inc.
Dental · 186d
Cleared Mar 19, 1998
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
K974202
Pulpdent Corp.
Dental · 129d
Cleared Feb 18, 1998
PULPDENT CAVITY VARNISH
K974398
Pulpdent Corp.
Dental · 89d
Cleared Dec 16, 1997
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
K973919
Medental Intl.
Dental · 62d
Cleared Dec 12, 1996
ULTRADENT UNIVERSAL DENTIN SEALANT
K963979
Ultradent Products, Inc.
Dental · 70d
Cleared Aug 14, 1996
DURAFLOR
K961893
Pharmascience, Inc.
Dental · 90d
Cleared Jan 24, 1996
ALPHA-DENT COPAL CAVITY VARNISH
K955521
Wallace A. Erickson & Co.
Dental · 51d
Cleared Sep 08, 1995
ULTRACID DISINFECTING SOLOUTION
K953167
Ultradent Products, Inc.
Dental · 63d
Cleared Sep 08, 1995
ULTRACID F DISINFECTING SOLUTION
K953168
Ultradent Products, Inc.
Dental · 63d
Cleared Mar 07, 1995
FLUOR PROTECTOR
K946032
Ivoclar North America, Inc.
Dental · 88d
Cleared Jan 07, 1994
BOSWORTH COPALIONER
K933505
Harry J. Bosworth Co.
Dental · 176d
Cleared Jul 22, 1993
CONSEPSIS SCRUB
K925375
Ultradent Products, Inc.
Dental · 272d
Cleared Jul 08, 1993
CONSEPSIS(TM)
K924982
Ultradent Products, Inc.
Dental · 280d
Cleared Jun 27, 1990
DENTIN PROTECTOR
K901915
Ivoclar North America, Inc.
Dental · 62d
Cleared May 29, 1990
COPAL VARNISH
K901049
Pulpdent Corp.
Dental · 85d
Cleared May 25, 1990
UNIVERSUM
K900946
Scientific Pharmaceuticals, Inc.
Dental · 85d
Cleared Jul 01, 1988
ESPE VARNISH
K880741
Espe GmbH (Us)
Dental · 128d
Cleared Jun 01, 1988
CONTAC, A DENTIN SEALANT
K881026
Harry J. Bosworth Co.
Dental · 83d
Cleared Apr 11, 1986
FLUOROSEAL, DENTIN SEALER AND CAVITY LINER
K860633
Scientific Pharmaceuticals, Inc.
Dental · 50d
Cleared Sep 23, 1985
UNIVAR UNIVERSAL DENTIN VARNISH
K852755
Scientific Pharmaceuticals, Inc.
Dental · 87d