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 Oct 15, 2012

Dentsply International, Inc.

Cleared Jul 25, 2012

Cleared Dec 22, 2010

GC America, Inc.

Cleared Apr 15, 2009

VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247

Cleared Jan 12, 2009

VOCO PROFLUORID L

Cleared Jul 24, 2008

VOCO PROFLUORID VARNISH

Cleared Feb 08, 2008

FLOR-OPAL VARNISH WHITE

Ultradent Products, Inc.

Cleared Oct 03, 2007

SULTAN TOOTH ROOT DESENSITIZER

Dentsply International, Inc.

Cleared Sep 21, 2007

Ivoclar Vivadent, Inc.

Cleared Jun 12, 2007

ULTRAEZ DESENSITIZING GEL

Ultradent Products, Inc.

Cleared Nov 21, 2006

ENAMEL PRO VARNISH

Premier Dental Products Co.

Cleared Sep 19, 2005

FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502

Ultradent Products, Inc.

Cleared Oct 17, 2003

Ivoclar Vivadent, Inc.

Cleared Sep 15, 2003

FLUORIDE VARNISH

Cleared Sep 26, 2002

Cleared Aug 19, 2002

SEAL & PROTECT PROTECTIVE SEALANT

Cleared Dec 12, 2001

PULPDENT CAVITY PREPARATION IV

Cleared Jun 25, 2001

QUELL DESENSITIZER

Jeneric/Pentron, Inc.

Cleared Mar 02, 2000

PULPDENT CAVITY PREPARATION III

Cleared Feb 29, 2000

PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE

Cleared Feb 23, 2000

PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE

Cleared Nov 17, 1999

SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE

Cleared Oct 22, 1999

D/SENSE II (GREEN-OR) DENTIN DESENSITIZER

Cleared Feb 12, 1999

SCI-PHARM DFV VARNISH

Scientific Pharmaceuticals, Inc.