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

97–120 of 402

2 3 4 5 6 7 8

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 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.

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 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 04, 1989

POLYETHER-RETARDER

Cleared Oct 27, 1989

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

2 3 4 5 6 7 8