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

49–72 of 138

Cleared May 12, 2010

PULPDENT COPAL VARNISH WITH FLUORIDE

Pulpdent Corporation

Cleared Mar 10, 2010

PULPDENT FLUORIDE VARNISH

Pulpdent Corporation

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 May 25, 2007

ASCENT DENTAL CLEANSER

CAO Group, Inc.

Cleared Nov 21, 2006

ENAMEL PRO VARNISH

Premier Dental Products Co.

Cleared Dec 16, 2005

MULTIPLE (TOOTH DESENSITIZER)

Cosmedent, Inc.

Cleared Sep 19, 2005

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

Ultradent Products, Inc.

Cleared Jun 07, 2005

PROTECT TOOTH DESENSITIZER

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

HEMASEAL & CIDE

Advantage Dental Products, Inc.