Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coe Laboratories, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
231 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903292 | ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS | Coe Laboratories, Inc. | 1990-10-19 | 87 | 0 |
| K894282 | FIRST IMPRESSION TM | Coe Laboratories, Inc. | 1989-12-22 | 182 | 0 |
| K894281 | FIRST IMPRESSION WITH CHLORHEXIDINE | Coe Laboratories, Inc. | 1989-09-26 | 95 | 0 |
| K891140 | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT | Coe Laboratories, Inc. | 1989-05-01 | 59 | 0 |
| K885010 | TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING | Coe Laboratories, Inc. | 1989-02-13 | 73 | 0 |
| K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET | Coe Laboratories, Inc. | 1988-10-31 | 209 | 0 |
| K881091 | OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL | Coe Laboratories, Inc. | 1988-06-28 | 112 | 0 |
| K863882 | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE | Coe Laboratories, Inc. | 1986-11-18 | 43 | 0 |
| K842877 | ABSOLUTE VINYL POLYSILOXANE IMPRESS | Coe Laboratories, Inc. | 1985-03-11 | 231 | 0 |
| K844325 | COE-LITE POLYMERIZATION UNIT | Coe Laboratories, Inc. | 1984-12-11 | 34 | 0 |
| K844326 | OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE | Coe Laboratories, Inc. | 1984-12-03 | 26 | 0 |
| K830294 | MEDICAL EXAM TABLE | Coe Laboratories, Inc. | 1984-01-11 | 349 | 0 |
| K833261 | INTERIM TEMP. CROWN & BRIDGE RESIN | Coe Laboratories, Inc. | 1984-01-03 | 102 | 0 |
| K831575 | NU-CAP CALCIUM HYDROX. PULP CAPPING | Coe Laboratories, Inc. | 1983-06-30 | 45 | 0 |
| K820673 | SELF-CURING HARD DENTURE LINER | Coe Laboratories, Inc. | 1982-04-09 | 29 | 0 |
| K792428 | COE-SIL | Coe Laboratories, Inc. | 1980-01-23 | 57 | 0 |
| K792427 | PERMA-CRYL 20 | Coe Laboratories, Inc. | 1979-12-13 | 16 | 0 |
| K771615 | AUDI-SIL EARMOLD MATERIAL | Coe Laboratories, Inc. | 1977-08-30 | 6 | 0 |
| K760225 | PUTTY, ACCOE | Coe Laboratories, Inc. | 1976-07-21 | 9 | 0 |
| K760226 | PASTE, ACCOE IMPRESSION | Coe Laboratories, Inc. | 1976-07-21 | 9 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda