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 Feb 16, 2000

ULTRASEAL XT PLUS

Ultradent Products, Inc.

Cleared Oct 22, 1999

NRC NON-RINSE CONDITIONER

Cleared Oct 08, 1999

3M CLINPRO SEALANT

Cleared Sep 22, 1999

PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM

Cleared Aug 27, 1999

DYRACT SEAL COMPOMER PIT & FISSURE SEALANT

Cleared Aug 20, 1999

DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT

Cleared Oct 06, 1998

DELTON FS DIRECT DELIVERY SYSTEM

Cleared Nov 12, 1996

PULPDENT SEAL-RITE UDMA

Cleared Apr 23, 1996

Cleared Jan 04, 1996

Sybron Dental Specialties, Inc.

Cleared Aug 18, 1995

TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION

Jeneric/Pentron, Inc.

Cleared May 03, 1995

DELTON F PIT & FISSURE SEALANT

Cleared Jan 17, 1995

PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT

Cleared Sep 20, 1993

PULPDENT SEAL-RITE LOW VISCOSITY

Cleared Sep 15, 1993

Ivoclar North America, Inc.

Cleared Jul 22, 1993

PRIMADRY PRODUCT LINE

Ultradent Products, Inc.

Cleared Jul 22, 1993

ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE

Ultradent Products, Inc.

Cleared Sep 28, 1992

ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN

Ultradent Products, Inc.

Cleared Sep 28, 1992

ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE

Ultradent Products, Inc.

Cleared Jan 17, 1992

Heraeus Kulzer, Inc.

Cleared Jun 10, 1991

PULPDENT SEAL RITE

Cleared Jul 20, 1990

Cleared Jul 13, 1990

SEAL RITE PROCEDURE KIT(TM)

Cleared Apr 23, 1990

FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE