ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Zhermack S.P.A., Dentsply Intl. and Cavex Holland BV.

402

Total

402

Cleared

95d

Avg days

1976

Since

402 devices

193–216 of 402

Cleared Mar 19, 1997

CUTTERSIL COMFORT HARDENER

Heraeus Kulzer, Inc.

Cleared Feb 25, 1997

J. Morita USA, Inc.

Cleared Dec 30, 1996

KROMALGIN IMPRESSION MATERIAL

North American Orthodontic Laboratories, Inc.

Cleared Dec 16, 1996

CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL

Fen Dental Mfg., Inc.

Cleared Nov 14, 1996

Zhermack S.P.A.

Cleared Oct 31, 1996

3M PROPLUS SYSTEM

Cleared Oct 29, 1996

ALGINMAX, ORTHOCHROME

American Tooth Industries

Cleared Sep 30, 1996

HYUNJAE DENTAL IMPRESSION MATERIALS

Cleared Sep 06, 1996

TRI-PHASIX CHROMATIC ALGINATE

Cleared Aug 13, 1996

JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL

Cleared Jun 24, 1996

PANASIL IMPRESSION MATERIAL

Roydent Dental Products, Inc.

Cleared May 17, 1996

BOSWORTH IMPRESSION MATERIAL II

Harry J. Bosworth Co.

Cleared Mar 15, 1996

DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE

Espe GmbH & Co. Kg.

Cleared Mar 11, 1996

EXAFLEX IMPRESSION MATERIAL (MODIFICATION)

GC America, Inc.

Cleared Mar 05, 1996

HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY

Van R Dental Products, Inc.

Cleared Feb 14, 1996

BOSWORTH IMPRESSION MATERIAL I

Harry J. Bosworth Co.

Cleared Dec 28, 1995

SCAN WHITE 12 ML

Cleared Dec 28, 1995

Cleared Dec 01, 1995

Espe GmbH & Co. Kg.

Cleared Nov 21, 1995

Espe GmbH & Co. Kg.

Cleared Sep 29, 1995

Cleared Sep 29, 1995

AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING

American Dental Products, Inc.

Cleared Sep 08, 1995

DENTRAY II PLUS TRAY ADHESIVE

Confi-Dental Products Co.

Cleared Aug 18, 1995

Espe GmbH & Co. Kg.