EBD · Class II · 21 CFR 872.3310

FDA Product Code EBD: Coating, Filling Material, Resin

Leading manufacturers include Bisco, Inc., Scientific Pharmaceuticals, Inc. and 3M Company.

52
Total
52
Cleared
87d
Avg days
1976
Since
52 devices
25–48 of 52
Cleared Aug 27, 1999
BELLEGLAZE
K992067
Kerr Dental Materials Center
Dental · 70d
Cleared Feb 04, 1999
CORE-IDE
K984037
Roydent Dental Products, Inc.
Dental · 84d
Cleared Mar 09, 1998
FLOWABLE HYBRID
K980298
Cosmedent, Inc.
Dental · 41d
Cleared Feb 10, 1998
RENAMEL FLOWABLE COMPOSITE
K974494
Cosmedent, Inc.
Dental · 74d
Cleared Apr 19, 1990
NO-STICK COMPOSITE INSTRUMENT DIP
K901050
Pulpdent Corp.
Dental · 45d
Cleared Jul 22, 1986
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590
3M Company
Dental · 15d
Cleared Jan 30, 1986
AUSTENAL DENTAL COMPOSITE RESIN
K854957
Austenal Dental, Inc.
Dental · 50d
Cleared Aug 19, 1985
ESPE KETAC-BOND
K844845
Espe GmbH (Us)
Dental · 249d
Cleared Mar 25, 1985
CURAY JOIN DENT DENTIN PRIMER
K850675
Scientific Pharmaceuticals, Inc.
Dental · 32d
Cleared Mar 18, 1985
CAULK DYCAL LIGHT CURED
K850641
Dentsply Intl.
Dental · 27d
Cleared Feb 08, 1985
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT
K850073
Johnson & Johnson Professionals, Inc.
Dental · 30d
Cleared May 11, 1984
OPAQUE COATING & SURFACE STAIN
K840751
Dentsply Intl.
Dental · 78d
Cleared Sep 29, 1983
CONCISE 2 SMALL PARTICLE LIGHT CURVED
K832834
3M Company
Dental · 41d
Cleared Dec 28, 1982
CBM, CORE BUILD-UP MATERIAL
K823732
Scientific Pharmaceuticals, Inc.
Dental · 18d
Cleared Oct 13, 1982
COMMAND BONDING RESIN/GLAZE/OPAQUER
K822869
Sybron Corp.
Dental · 16d
Cleared Sep 28, 1982
CONCLUDE COMPOSITE LUTING CEMENT
K822714
3M Company
Dental · 21d
Cleared Feb 24, 1982
MYERSON/KENSON GP POLYMER
K813328
Howmedica Corp.
Dental · 92d
Cleared Aug 10, 1979
SCI-PHARM PAINT-ON RESTORATIVE
K791067
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Aug 10, 1979
ANTERIOR/POSTERIOR RESTORATIVE, BOND
K791078
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Apr 10, 1979
COLORANT
K790438
Vivadent (Usa), Inc.
Dental · 34d
Cleared Aug 23, 1976
ADHESION PROMOTOR
K760419
Lee Pharmaceuticals
Dental · 14d