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

49–72 of 131

Cleared Jun 10, 1999

AMERICAN DENTAL PRODUCTS ETCH-DETECT

American Dental Products, Inc.

Cleared May 14, 1999

Southern Dental Industries, Inc.

Cleared Mar 03, 1999

HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025

Kay See Dental Mfg. Co.

Cleared Oct 06, 1998

DELTON FS DIRECT DELIVERY SYSTEM

Cleared Nov 25, 1997

MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED

Cleared Mar 27, 1997

Kuraray Company, Ltd.

Cleared Nov 12, 1996

PULPDENT SEAL-RITE UDMA

Cleared Apr 23, 1996

Cleared Mar 08, 1996

Foremost Dental Mfg., Inc.

Cleared Jan 04, 1996

Sybron Dental Specialties, Inc.

Cleared Oct 30, 1995

AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING

American Dental Products, 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

SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT

Confi-Dental Products Co.

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 Jul 22, 1993

BARITONE C2, MODIFICATION

Confi-Dental Products Co.

Cleared Oct 16, 1992

ALPHA-DENT PIT AND FISSURE SEALANT

Wallace A. Erickson & Co.

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.