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

241–264 of 402

Cleared Jul 25, 1991

COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC

Coltene/Whaledent, Inc.

Cleared Jun 06, 1991

CUTTERSIL MUCOSA

Heraeus Kulzer, Inc.

Cleared Jun 06, 1991

Heraeus Kulzer, Inc.

Cleared Jun 06, 1991

PERFOURM PUTTY SOFT

Heraeus Kulzer, Inc.

Cleared Jun 06, 1991

CUTTERSIL FUNCTION ACTIVATOR

Heraeus Kulzer, Inc.

Cleared Nov 29, 1990

Kerr Corporation (Danbury)

Cleared Oct 19, 1990

ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS

Coe Laboratories, Inc.

Cleared Sep 07, 1990

DEGUFLEX (R) CS LIGHT

Cleared Sep 06, 1990

DEGUFLEX MONOPHASE

Cleared Sep 06, 1990

DEGUFLEX (R) CS PUTTY

Cleared Jun 15, 1990

FORMASIL(R)A POLYVINYL SILOXANE LINE

Cleared Apr 30, 1990

EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL

Ivoclar North America, Inc.

Cleared Feb 09, 1990

PERMADYNE GARANT LOW VISCOSITY

Cleared Dec 22, 1989

FIRST IMPRESSION TM

Coe Laboratories, Inc.

Cleared Dec 04, 1989

POLYETHER-RETARDER

Cleared Oct 27, 1989

Cleared Sep 26, 1989

FIRST IMPRESSION WITH CHLORHEXIDINE

Coe Laboratories, Inc.

Cleared Jul 14, 1989

RESOUND IMPRESSION MATERIAL

Cleared Apr 17, 1989

DICOR CERAMIC INLAY - NEW TECHNIC

Cleared Mar 17, 1989

DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.

Cleared Jan 04, 1989

PALGAFLEX AND PALGAFLEX-QUICK

Cleared Aug 11, 1988

IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL

Cleared Jun 28, 1988

OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL

Coe Laboratories, Inc.

Cleared Jul 21, 1987

VINYL POLYSILOXANE IMPRESSION SYSTEM

Crown Delta Corp.