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

217–240 of 402

Cleared Aug 18, 1995

PERMADYNE GARANT 2:1

Espe GmbH & Co. Kg.

Cleared Jul 19, 1995

PERMADYNE PENTA (HIGH & LOW VISCOSITY)

Espe GmbH & Co. Kg.

Cleared Mar 31, 1995

S & C VINYL POLYSILOXANE IMPRESSION MATERIAL

S & C Polymer GmbH

Cleared Sep 12, 1994

GC America, Inc.

Cleared Aug 23, 1994

CAPTURE IMPRESSION MATERIAL

Cleared Aug 12, 1994

ULTRA HYDROPHILIC ALGINAE

Essential Dental Systems, Inc.

Cleared Aug 10, 1994

ORTHALGENAT IMPRESSION MATERIAL

Dentauraum, Inc.

Cleared May 27, 1994

CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS

Ultradent Products, Inc.

Cleared Apr 28, 1994

PRETREATMENT SOLUTION

Cleared Apr 04, 1994

HYDROCOLLOID HEATING UNIT

Cleared Mar 28, 1994

SUPERGEL/SUPPRESSED DUST

Harry J. Bosworth Co.

Cleared Mar 22, 1994

Sybron Dental Specialties, Inc.

Cleared Feb 25, 1994

Wallace A. Erickson & Co.

Cleared Feb 04, 1994

TREND SET 2 PLUS

Confi-Dental Products Co.

Cleared Jan 07, 1994

VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM

Crown Delta Corp.

Cleared Sep 29, 1993

EXA BITE REGISTRATION MATERIAL

GC America, Inc.

Cleared Aug 09, 1993

FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL

Cleared May 05, 1993

VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD

Harry J. Bosworth Co.

Cleared Mar 18, 1993

TRIANGULAR JAW MICROLARYNGEAL FORCEPS

Cleared Aug 27, 1992

Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL

Jeneric/Pentron, Inc.

Cleared Apr 28, 1992

CORRECTED-V.P.S.

Jeneric/Pentron, Inc.

Cleared Jan 17, 1992

VITA CEREC SET AND VITA CEREC BLOCS

Cleared Jan 17, 1992

Jeneric/Pentron, Inc.

Cleared Oct 04, 1991

Heraeus Kulzer, Inc.