ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Dentsply Intl., GC America, Inc. and Heraeus Kulzer, Inc..

402

Total

402

Cleared

95d

Avg days

1976

Since

402 devices

73–96 of 402

1 2 3 4 5 6 7

Cleared Oct 16, 1998

B-SYSTEM SILICONE

Sybron Dental Specialties, Inc.

Cleared Jun 11, 1998

3M M.G. MATERIAL

Cleared Dec 11, 1997

AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL

Cleared Dec 04, 1997

AQUASIL XLV SMART WETTING IMPRESSION MATERIAL

Cleared Nov 24, 1997

Heraeus Kulzer, Inc.

Cleared Oct 21, 1997

GC America, Inc.

Cleared May 22, 1997

Heraeus Kulzer, Inc.

Cleared Apr 08, 1997

GC America, Inc.

Cleared Mar 27, 1997

AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL

Cleared Mar 19, 1997

CUTTERSIL COMFORT

Heraeus Kulzer, Inc.

Cleared Mar 19, 1997

CUTTERSIL COMFORT HARDENER

Heraeus Kulzer, Inc.

Cleared Feb 25, 1997

J. Morita USA, Inc.

Cleared Oct 31, 1996

3M PROPLUS SYSTEM

Cleared Sep 06, 1996

TRI-PHASIX CHROMATIC ALGINATE

Cleared Aug 13, 1996

JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL

Cleared May 17, 1996

BOSWORTH IMPRESSION MATERIAL II

Harry J. Bosworth Co.

Cleared Mar 11, 1996

EXAFLEX IMPRESSION MATERIAL (MODIFICATION)

GC America, Inc.

Cleared Feb 14, 1996

BOSWORTH IMPRESSION MATERIAL I

Harry J. Bosworth Co.

Cleared Dec 28, 1995

SCAN WHITE 12 ML

Cleared Sep 29, 1995

Cleared Sep 12, 1994

GC America, Inc.

Cleared Aug 23, 1994

CAPTURE IMPRESSION MATERIAL

Cleared May 27, 1994

CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS

Ultradent Products, Inc.

Cleared Apr 28, 1994

PRETREATMENT SOLUTION

1 2 3 4 5 6 7