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..

140
Total
140
Cleared
127d
Avg days
1976
Since
140 devices
49–72 of 140
Cleared Oct 21, 2010
TOKUYAMA SHIELD FORCE
K100172
Tokuyama Dental Corporation
Dental · 273d
Cleared Sep 23, 2010
ASCENT F-COAT MODEL: 006-00097
K100540
CAO Group, Inc.
Dental · 210d
Cleared May 12, 2010
PULPDENT COPAL VARNISH WITH FLUORIDE
K100503
Pulpdent Corporation
Dental · 79d
Cleared Mar 10, 2010
VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
K092141
3M Espe Dental Products
Dental · 238d
Cleared Mar 10, 2010
PULPDENT FLUORIDE VARNISH
K093620
Pulpdent Corporation
Dental · 107d
Cleared Mar 05, 2010
GLUMA DESENSITIZER POWER GEL
K093575
Heraeus Kulzer, LLC
Dental · 107d
Cleared Apr 15, 2009
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K090519
3M Company
Dental · 48d
Cleared Mar 19, 2009
REMESENSE
K082594
Remedent NV
Dental · 192d
Cleared Mar 16, 2009
FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH
K090597
Pascal Co., Inc.
Dental · 11d
Cleared Jan 12, 2009
VOCO PROFLUORID L
K083036
Voco GmbH
Dental · 90d
Cleared Oct 29, 2008
DURASHIELD PLUS
K082198
Dentsply Intl., Inc.
Dental · 86d
Cleared Oct 02, 2008
ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT
K082071
Adpharma, Inc.
Dental · 72d
Cleared Jul 24, 2008
VOCO PROFLUORID VARNISH
K080814
Voco GmbH
Dental · 122d
Cleared Mar 27, 2008
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
K080228
Novamin Technology, Inc.
Dental · 57d
Cleared Feb 29, 2008
THE PROXIVENT KIT
K073061
Coll Partners , Ltd.
Dental · 122d
Cleared Feb 08, 2008
FLOR-OPAL VARNISH WHITE
K080249
Ultradent Products, Inc.
Dental · 8d
Cleared Dec 19, 2007
DENTIN DESENSITIZER AGENT
K073117
Dentsply Intl., Inc.
Dental · 44d
Cleared Oct 03, 2007
SULTAN TOOTH ROOT DESENSITIZER
K072342
Dentsply International, Inc.
Dental · 43d
Cleared Sep 21, 2007
CERVITEC PLUS
K072338
Ivoclar Vivadent, Inc.
Dental · 32d
Cleared Jun 12, 2007
ULTRAEZ DESENSITIZING GEL
K061438
Ultradent Products, Inc.
Dental · 384d
Cleared May 25, 2007
ASCENT DENTAL CLEANSER
K070070
CAO Group, Inc.
Dental · 137d
Cleared May 18, 2007
PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
K071267
Novamin Technology, Inc.
Dental · 11d
Cleared May 04, 2007
ACQUASEAL BENZ
K070289
Acquamed Technologies, Inc.
Dental · 94d
Cleared Jan 10, 2007
RELIEF ACP ORAL CARE GEL
K062176
Discus Dental, Inc.
Dental · 163d