Coe Laboratories, Inc.: FDA clearances and approvals
Coe Laboratories, Inc. has 20 FDA 510(k) clearances (first 1976, latest 1990), across 12 product codes in 3 review panels. Median 510(k) review time: 58 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELW | Material, Impression | 7 | 7 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| ESH | Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Plus 2 more product codes.
Review panels
- Dental (17)
- Ear, Nose and Throat (2)
- General Hospital (1)
Most recent Coe Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903292 | ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS | ELW | 1990-10-19 | 87 |
| K894282 | FIRST IMPRESSION TM | ELW | 1989-12-22 | 182 |
| K894281 | FIRST IMPRESSION WITH CHLORHEXIDINE | ELW | 1989-09-26 | 95 |
| K891140 | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT | EBC | 1989-05-01 | 59 |
| K885010 | TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING | KLE | 1989-02-13 | 73 |
| K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET | EMA | 1988-10-31 | 209 |
| K881091 | OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | 1988-06-28 | 112 |
| K863882 | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE | EBF | 1986-11-18 | 43 |
| K842877 | ABSOLUTE VINYL POLYSILOXANE IMPRESS | ELW | 1985-03-11 | 231 |
| K844325 | COE-LITE POLYMERIZATION UNIT | EBZ | 1984-12-11 | 34 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coe Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Coe Laboratories, Inc. have?
Coe Laboratories, Inc. has 20 FDA 510(k) clearances (first 1976, latest 1990), across 12 product codes in 3 review panels.
How long does FDA take to clear Coe Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Coe Laboratories, Inc.'s cleared 510(k)s is 58 days.
What devices does Coe Laboratories, Inc. make?
Its most frequent FDA product codes are ELW (Material, Impression, 7); EBF (Material, Tooth Shade, Resin, 2); EBI (Resin, Denture, Relining, Repairing, Rebasing, 2).
Has Coe Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Coe Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 20 Coe Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELW, Coe Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.