Company ยท US
Coe Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1990. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ELW | Material, Impression | 7 |
| EBF | Material, Tooth Shade, Resin | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 |
| EMA | Cement, Dental | 1 |
| ESH | Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 |
| LDG | Kit, Earmold, Impression | 1 |
| LGX | Table, Examination, Medical, Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 1990 | K903292 | ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS Coe Laboratories, Inc. | ELW |
| Dec 22, 1989 | K894282 | FIRST IMPRESSION TM Coe Laboratories, Inc. | ELW |
| Sep 26, 1989 | K894281 | FIRST IMPRESSION WITH CHLORHEXIDINE Coe Laboratories, Inc. | ELW |
| May 1, 1989 | K891140 | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT Coe Laboratories, Inc. | EBC |
| Feb 13, 1989 | K885010 | TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING Coe Laboratories, Inc. | KLE |
| Oct 31, 1988 | K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET Coe Laboratories, Inc. | EMA |
| Jun 28, 1988 | K881091 | OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL Coe Laboratories, Inc. | ELW |
| Nov 18, 1986 | K863882 | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE Coe Laboratories, Inc. | EBF |
| Mar 11, 1985 | K842877 | ABSOLUTE VINYL POLYSILOXANE IMPRESS Coe Laboratories, Inc. | ELW |
| Dec 11, 1984 | K844325 | COE-LITE POLYMERIZATION UNIT Coe Laboratories, Inc. | EBZ |
| Dec 3, 1984 | K844326 | OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE Coe Laboratories, Inc. | EBF |
| Jan 11, 1984 | K830294 | MEDICAL EXAM TABLE Coe Laboratories, Inc. | LGX |
| Jan 3, 1984 | K833261 | INTERIM TEMP. CROWN & BRIDGE RESIN Coe Laboratories, Inc. | EBG |
| Jun 30, 1983 | K831575 | NU-CAP CALCIUM HYDROX. PULP CAPPING Coe Laboratories, Inc. | EJK |
| Apr 9, 1982 | K820673 | SELF-CURING HARD DENTURE LINER Coe Laboratories, Inc. | EBI |
| Jan 23, 1980 | K792428 | COE-SIL Coe Laboratories, Inc. | LDG |
| Dec 13, 1979 | K792427 | PERMA-CRYL 20 Coe Laboratories, Inc. | EBI |
| Aug 30, 1977 | K771615 | AUDI-SIL EARMOLD MATERIAL Coe Laboratories, Inc. | ESH |
| Jul 21, 1976 | K760226 | PASTE, ACCOE IMPRESSION Coe Laboratories, Inc. | ELW |
| Jul 21, 1976 | K760225 | PUTTY, ACCOE Coe Laboratories, Inc. | ELW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||