EBD · Class II · 21 CFR 872.3310

FDA Product Code EBD: Coating, Filling Material, Resin

Leading manufacturers include Bisco, Inc., Scientific Pharmaceuticals, Inc. and Cosmedent, Inc..

52

Total

52

Cleared

87d

Avg days

1976

Since

52 devices

25–48 of 52

Cleared Feb 14, 2002

Cosmedent, Inc.

Cleared Oct 12, 2001

Cleared Aug 27, 1999

Kerr Dental Materials Center

Cleared Feb 04, 1999

Roydent Dental Products, Inc.

Cleared Mar 09, 1998

FLOWABLE HYBRID

Cosmedent, Inc.

Cleared Feb 10, 1998

RENAMEL FLOWABLE COMPOSITE

Cosmedent, Inc.

Cleared Jan 21, 1994

IONOSIT BASE LINER

Foremost Dental Mfg., Co.

Cleared May 15, 1991

FOUNDATION HYBRID COMPOSITE

Nulite Systems Research

Cleared Apr 19, 1990

NO-STICK COMPOSITE INSTRUMENT DIP

Cleared Jul 22, 1986

3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)

Cleared Jan 30, 1986

AUSTENAL DENTAL COMPOSITE RESIN

Austenal Dental, Inc.

Cleared Aug 19, 1985

ESPE KETAC-BOND

Cleared May 15, 1985

PEPSODENT DENTURE ADHESIVE CREAM

Lever Brothers Company, Inc.

Cleared Mar 25, 1985

CURAY JOIN DENT DENTIN PRIMER

Scientific Pharmaceuticals, Inc.

Cleared Mar 18, 1985

CAULK DYCAL LIGHT CURED

Cleared Feb 08, 1985

J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT

Johnson & Johnson Professionals, Inc.

Cleared May 11, 1984

OPAQUE COATING & SURFACE STAIN

Cleared Sep 29, 1983

CONCISE 2 SMALL PARTICLE LIGHT CURVED

Cleared Dec 28, 1982

CBM, CORE BUILD-UP MATERIAL

Scientific Pharmaceuticals, Inc.

Cleared Oct 13, 1982

COMMAND BONDING RESIN/GLAZE/OPAQUER

Cleared Sep 28, 1982

CONCLUDE COMPOSITE LUTING CEMENT

Cleared Feb 24, 1982

MYERSON/KENSON GP POLYMER

Howmedica Corp.

Cleared Apr 14, 1981

DMG-POLISHABLE COMPOSITE

Dental-Material Gesellschaft

Cleared Aug 10, 1979

SCI-PHARM PAINT-ON RESTORATIVE

Scientific Pharmaceuticals, Inc.