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

73–96 of 131

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 Mar 16, 1993

MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE

Cleared Dec 23, 1992

Mirage Dental Systems

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 Aug 27, 1992

Cleared Jan 17, 1992

Heraeus Kulzer, Inc.

Cleared Oct 23, 1991

PIT AND FISSURE SEALANT PRODUCTS

Confi-Dental Products Co.

Cleared Oct 23, 1991

BARITONE C2 & BARITONE L3

Confi-Dental Products Co.

Cleared Jun 10, 1991

PULPDENT SEAL RITE

Cleared May 07, 1991

Gresco Products, Inc.

Cleared Apr 29, 1991

POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND

Milton Hodosh, M.D.

Cleared Sep 12, 1990

DEGUFILL (TM) WHIT-SEALANT

Cleared Jul 20, 1990

Cleared Jul 13, 1990

SEAL RITE PROCEDURE KIT(TM)

Cleared Apr 23, 1990

FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE

Cleared Mar 14, 1990

Cleared May 01, 1989

OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT

Coe Laboratories, Inc.

Cleared Mar 29, 1989

FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS

Macrochem Corp.

Cleared Feb 13, 1989

ZENITH 40% PHOSPHORIC ACID GEL

Foremost Dental Mfg., Inc.

Cleared Feb 29, 1988

ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT

Mission White Dental, Inc.