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
25–48 of 138
Cleared Sep 18, 2015
Clinpro Varnish
K151302
3M Company
Dental · 126d
Cleared Jan 29, 2015
LISTERINE Sensitivity Defense Mouthrinse
K143155
Johnson & Johnson Healthcare Products, Division of Mcneil-Pp
Dental · 87d
Cleared Dec 12, 2014
VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
K140350
Preventive Technologies, Inc.
Dental · 304d
Cleared Oct 08, 2014
FLUOR PROTECTOR S
K131487
Ivoclar Vivadent, AG
Dental · 503d
Cleared Sep 30, 2014
PROFLUORO FLUORIDE VARNISH
K141422
Pac-Dent International, Inc.
Dental · 123d
Cleared Sep 22, 2014
STARBRIGHT 5% SODIUM FLUORIDE VARNISH
K140349
Nanova Biomaterials, Inc.
Dental · 215d
Cleared Jun 05, 2014
COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
K140481
Colgate-Palmolive Company
Dental · 99d
Cleared Feb 14, 2014
SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS
K132426
Sylphar N.V.
Dental · 193d
Cleared Nov 01, 2013
ENAMELAST
K132109
Ultradent Products Inc. / Oratech, LLC
Dental · 116d
Cleared Sep 18, 2013
ALPHA-PRO WHITE VARNISH
K124025
Dental Technologies, Inc.
Dental · 264d
Cleared Aug 27, 2013
SMARTCOAT 2.5% NAF VARNISH
K131376
Elevate Oral Care
Dental · 105d
Cleared Jun 03, 2013
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653
Bisco, Inc.
Dental · 188d
Cleared Apr 26, 2013
PRG BARRIER COAT
K122908
Shofu Dental Corporation
Dental · 217d
Cleared Jan 14, 2013
REMESENSE FOR SENSITIVE TEETH
K122708
Sylphar N.V.
Dental · 132d
Cleared Oct 15, 2012
CAVITY VARNISH
K122331
Dentsply International, Inc.
Dental · 74d
Cleared Jul 25, 2012
SENZZZZZ AWAY
K120176
Centrix, Inc.
Dental · 187d
Cleared Mar 07, 2012
SUPER SEAL TOOTH DESENSITIZER
K120109
Phoenix Dental, Inc.
Dental · 54d
Cleared Jan 23, 2012
PCXX VARNISH
K113146
Ross Healthcare, Inc.
Dental · 91d
Cleared Dec 09, 2011
ACTIV VARNISH
K112946
Pulpdent Corporation
Dental · 66d
Cleared Sep 13, 2011
COLGATE DESENSITIZING DENTAL CREAM
K103461
Colgate-Palmolive Co.
Dental · 293d
Cleared Jan 06, 2011
NUPRO MODEL 13016901
K103160
CAO Group, Inc.
Dental · 72d
Cleared Dec 22, 2010
MI VARNISH
K102808
GC America, Inc.
Dental · 85d
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