Coe Laboratories, Inc.
Mchenry, IL, US
Coe Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Coe Laboratories, Inc. between 1976 and 1990. The busiest year on record is 1984, with 4. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 4 |
| 1985 | 1 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K903292 | ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS | ELW | Substantially Equivalent | |
| K894282 | FIRST IMPRESSION TM | ELW | Substantially Equivalent | |
| K894281 | FIRST IMPRESSION WITH CHLORHEXIDINE | ELW | Substantially Equivalent | |
| K891140 | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT | EBC | Substantially Equivalent | |
| K885010 | TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING | KLE | Substantially Equivalent | |
| K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET | EMA | Substantially Equivalent | |
| K881091 | OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | |
| K863882 | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE | EBF | Substantially Equivalent | |
| K842877 | ABSOLUTE VINYL POLYSILOXANE IMPRESS | ELW | Substantially Equivalent | |
| K844325 | COE-LITE POLYMERIZATION UNIT | EBZ | Substantially Equivalent | |
| K844326 | OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE | EBF | Substantially Equivalent | |
| K830294 | MEDICAL EXAM TABLE | LGX | Substantially Equivalent | |
| K833261 | INTERIM TEMP. CROWN & BRIDGE RESIN | EBG | Substantially Equivalent | |
| K831575 | NU-CAP CALCIUM HYDROX. PULP CAPPING | EJK | Substantially Equivalent | |
| K820673 | SELF-CURING HARD DENTURE LINER | EBI | Substantially Equivalent | |
| K792428 | COE-SIL | LDG | Substantially Equivalent | |
| K792427 | PERMA-CRYL 20 | EBI | Substantially Equivalent | |
| K771615 | AUDI-SIL EARMOLD MATERIAL | ESH | Substantially Equivalent | |
| K760226 | PASTE, ACCOE IMPRESSION | ELW | Substantially Equivalent | |
| K760225 | PUTTY, ACCOE | ELW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- KLEAgent, Tooth Bonding, Resin
- EMACement, Dental
- EBGCrown And Bridge, Temporary, Resin
- LDGKit, Earmold, Impression
- EJKLiner, Cavity, Calcium Hydroxide
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- ESHPolymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
- EBIResin, Denture, Relining, Repairing, Rebasing
- EBCSealant, Pit And Fissure, And Conditioner
- LGXTable, Examination, Medical, Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain