EBC · Class II · 21 CFR 872.3765

FDA Product Code EBC: Sealant, Pit And Fissure, And Conditioner

Leading manufacturers include Dentsply Intl., Ultradent Products, Inc. and Pulpdent Corp..

131

Total

131

Cleared

81d

Avg days

1976

Since

131 devices

25–48 of 131

Cleared Sep 18, 2008

INFILTRATION KIT

Cleared Jun 05, 2007

AURALAY PIT & FISSURE SEALANT

Denali Corporation

Cleared Nov 06, 2006

ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019

CAO Group, Inc.

Cleared Oct 04, 2006

PREMIER SELF-ETCHING ENAMEL SEALANT

Premier Dental Products Co.

Cleared Oct 02, 2006

Cleared Jul 21, 2006

ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE

Cleared Feb 08, 2006

EMBRACE WETBOND CLEAR SEALANT

Pulpdent Corporation

Cleared Dec 20, 2005

ASCENT PIT & FISSURE SEALANT

CAO Group, Inc.

Cleared Jul 28, 2005

Harry J. Bosworth Co.

Cleared Jun 10, 2005

Southern Dental Industries, Inc.

Cleared May 11, 2005

DELTON ILLUMINATING PIT AND FISSURE SEALING

Dentsply International

Cleared Dec 01, 2004

COSMEDENT PIT & FISSURE SEALANT

Cosmedent, Inc.

Cleared Feb 05, 2004

AEGIS PIT & FISSURE SEALANT WITH ACP

Harry J. Bosworth Co.

Cleared Sep 04, 2003

PIT & FISSURE SEALANT WITH FLUORIDE

Harry J. Bosworth Co.

Cleared Jul 29, 2002

Cleared Jul 19, 2002

Cleared Apr 12, 2002

DENTITION INTEGRATING MATERIAL

Pulpdent Corporation

Cleared Nov 01, 2001

PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT

Prime Dental Manufacturing, Inc.

Cleared Oct 16, 2001

GC America, Inc.

Cleared Sep 14, 2001

Kuraray Medical, Inc.

Cleared Sep 06, 2001

OPTIBOND SOLO PLUS 3

Kerr Dental Materials Center

Cleared Aug 16, 2001

HELIOSEAL CLEAR CHROMA

Ivoclar North America, Inc.

Cleared Aug 07, 2001

PIT AND FISSURE CHEMICAL CURING SEALANT

Rite-Dent Manufacturing Corp.

Cleared Feb 16, 2000

ULTRASEAL XT PLUS

Ultradent Products, Inc.