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

73–96 of 140

Cleared Nov 21, 2006

ENAMEL PRO VARNISH

Premier Dental Products Co.

Cleared Oct 18, 2006

DENSHIELD TREATMENT FOR SENSITIVE TEETH

Novamin Technology, Inc.

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 Sep 02, 2004

ORALIEF THERAPY FOR SENSITIVE TEETH

Novamin Technology, Inc.

Cleared Mar 10, 2004

ORAVIVE TOOTH REVITALIZING PASTE

Novamin Technology, Inc.

Cleared Feb 04, 2004

Medical Products Laboratories, Inc.

Cleared Oct 28, 2003

BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN

Novamin Technology, Inc.

Cleared Oct 17, 2003

Ivoclar Vivadent, Inc.

Cleared Sep 15, 2003

FLUORIDE VARNISH

Cleared May 02, 2003

Pascal Co., Inc.

Cleared Nov 25, 2002

AQUEOUS ACRYLIC DISPERSION 28% W/W

Chx Technologies, Inc.

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 Apr 20, 2001

Rite-Dent Manufacturing Corp.

Cleared Feb 01, 2001

PROCLUDE-SENSITIVE

Ortek Therapeutics, Inc.

Cleared Oct 20, 2000

DURAGARD SODIUM FLUORIDE VARNISH

Sultan Dental Products, Ltd.

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.