Not currently registered with FDA under this name
Coe Laboratories, Inc.
Alsip, IL, United States. Named as applicant on 17 dental 510(k) clearances between 1976 and 1990. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 171976–1990
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1976–2026
510(k) clearances
Clearances on which FDA names Coe Laboratories, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Oct 1990 | K903292 | ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS | ELW Impression Material |
| 22 Dec 1989 | K894282 | FIRST IMPRESSION TM | ELW Impression Material |
| 26 Sep 1989 | K894281 | FIRST IMPRESSION WITH CHLORHEXIDINE | ELW Impression Material |
| 1 May 1989 | K891140 | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 13 Feb 1989 | K885010 | TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING | KLE Resin Tooth Bonding Agent |
| 31 Oct 1988 | K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET | EMA Dental Cement |
| 28 Jun 1988 | K881091 | OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW Impression Material |
| 18 Nov 1986 | K863882 | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE | EBF Resin Tooth Shade Material |
| 11 Mar 1985 | K842877 | ABSOLUTE VINYL POLYSILOXANE IMPRESS | ELW Impression Material |
| 11 Dec 1984 | K844325 | COE-LITE POLYMERIZATION UNIT | EBZ Ultraviolet Activator for Polymerization |
| 3 Dec 1984 | K844326 | OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE | EBF Resin Tooth Shade Material |
| 3 Jan 1984 | K833261 | INTERIM TEMP. CROWN & BRIDGE RESIN | EBG Resin Temporary Crown and Bridge |
| 30 Jun 1983 | K831575 | NU-CAP CALCIUM HYDROX. PULP CAPPING | EJK Calcium Hydroxide Cavity Liner |
| 9 Apr 1982 | K820673 | SELF-CURING HARD DENTURE LINER | EBI Rebasing Repairing Relining Denture Resin |
| 13 Dec 1979 | K792427 | PERMA-CRYL 20 | EBI Rebasing Repairing Relining Denture Resin |
| 21 Jul 1976 | K760226 | PASTE, ACCOE IMPRESSION | ELW Impression Material |
| 21 Jul 1976 | K760225 | PUTTY, ACCOE | ELW Impression Material |
Some of these clearances are listed with FDA today by another company: GC America Inc. (6).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.