EBF · Class II · 21 CFR 872.3690

FDA Product Code EBF: Material, Tooth Shade, Resin

Under FDA product code EBF, tooth-shade resin materials are cleared for use in direct and indirect dental restorations.

These composite resins are formulated to match the natural color and translucency of tooth structure, enabling esthetic restorations in both anterior and posterior teeth. Modern formulations offer high radiopacity, low polymerization shrinkage, and wear resistance comparable to amalgam.

EBF devices are Class II medical devices, regulated under 21 CFR 872.3690 and reviewed by the FDA Dental panel.

Leading manufacturers include Voco GmbH, Bisco, Inc. and Scientific Pharmaceuticals, Inc..

933

Total

933

Cleared

88d

Avg days

1976

Since

933 devices

217–240 of 933

Cleared Apr 28, 2005

Shofu Dental Corp.

Cleared Apr 22, 2005

DYRACT EXTRA RESTORATIVE

Cleared Feb 01, 2005

TESCERA OPAQUER POWDER/SCULPTING RESIN

Cleared Dec 17, 2004

Ultradent Products, Inc.

Cleared Dec 17, 2004

CLEAFIL DC CORE AUTOMIX

Kuraray Medical, Inc.

Cleared Nov 18, 2004

GRADIA DIRECT LOFLO

GC America, Inc.

Cleared Nov 09, 2004

TETRIC EVOCERAM

Ivoclar Vivadent, Inc.

Cleared May 17, 2004

Ivoclar Vivadent, Inc.

Cleared Mar 26, 2004

CLEARFIL PHOTO CORE PLT

Kuraray Medical, Inc.

Cleared Feb 02, 2004

GC America, Inc.

Cleared Dec 30, 2003

Heraeus Kulzer, Inc.

Cleared Dec 22, 2003

Kuraray Medical, Inc.

Cleared Nov 25, 2003

Cleared Nov 13, 2003

Sybron Dental Specialties, Inc.

Cleared Jun 06, 2003

TESCERAFLO A2, MODEL T-21012P

Cleared May 30, 2003

Cleared May 30, 2003

Cleared Feb 14, 2003

Ivoclar Vivadent, Inc.

Cleared Jan 30, 2003

GC America, Inc.

Cleared Oct 25, 2002

CLEARFIL AP-X PLT

Kuraray Medical, Inc.

Cleared Oct 24, 2002

CLEARFIL AP-X PLT INTRO KIT

Kuraray Medical, Inc.

Cleared Oct 10, 2002

Cleared Mar 28, 2002

GC America, Inc.

Cleared Mar 06, 2002