Medical Device Manufacturer · US , Mchenry , IL

Coe Laboratories, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1976

Recent clearances: ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS, FIRST IMPRESSION TM, FIRST IMPRESSION WITH CHLORHEXIDINE

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coe Laboratories, Inc. Dental ✕

17 devices

1-17 of 17

Cleared Oct 19, 1990

ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS

Cleared Dec 22, 1989

FIRST IMPRESSION TM

Cleared Sep 26, 1989

FIRST IMPRESSION WITH CHLORHEXIDINE

Cleared May 01, 1989

OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT

Cleared Feb 13, 1989

TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING

Cleared Oct 31, 1988

COE PAK AUTO MIX, REGULAR OR HARD SET

Cleared Jun 28, 1988

OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL

Cleared Nov 18, 1986

OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE

Cleared Mar 11, 1985

ABSOLUTE VINYL POLYSILOXANE IMPRESS

Cleared Dec 11, 1984

COE-LITE POLYMERIZATION UNIT

Cleared Dec 03, 1984

OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE

Cleared Jan 03, 1984

INTERIM TEMP. CROWN & BRIDGE RESIN

Cleared Jun 30, 1983

NU-CAP CALCIUM HYDROX. PULP CAPPING

Cleared Apr 09, 1982

SELF-CURING HARD DENTURE LINER

Cleared Dec 13, 1979

Cleared Jul 21, 1976

Cleared Jul 21, 1976

PASTE, ACCOE IMPRESSION