Coltene, Inc.: FDA clearances and approvals
Coltene, Inc. has 13 FDA 510(k) clearances (first 1981, latest 1990), across 6 product codes in 1 review panel. Median 510(k) review time: 32 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 | 6 | 6 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EJJ | Alloy, Amalgam | 2 | 2 |
| EID | Syringe, Restorative And Impression Material | 1 | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (13)
Most recent Coltene, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902392 | COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL | EMA | 1990-08-28 | 90 |
| K882800 | COLTENE PRESIDENT JET REGULAR BODY | ELW | 1988-09-23 | 78 |
| K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM | EKS | 1987-10-27 | 46 |
| K870266 | COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM | EBF | 1987-02-27 | 35 |
| K870047 | COLTENE RAPID | ELW | 1987-01-29 | 23 |
| K863998 | COLTENE JET-MIXER | EID | 1986-10-30 | 16 |
| K850036 | COLTENE PRECISE | ELW | 1985-02-08 | 32 |
| K840297 | COLTENE ORALLOY MAGICAPS | EJJ | 1984-03-16 | 52 |
| K811767 | COLTENE PRESIDENT IMPRESSION MATERIALS | ELW | 1981-07-15 | 23 |
| K811667 | COLTENE PRESSURE SPOT INDICATOR | ELW | 1981-07-15 | 30 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coltene, 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 Coltene, Inc. have?
Coltene, Inc. has 13 FDA 510(k) clearances (first 1981, latest 1990), across 6 product codes in 1 review panel.
How long does FDA take to clear Coltene, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Coltene, Inc.'s cleared 510(k)s is 32 days.
What devices does Coltene, Inc. make?
Its most frequent FDA product codes are ELW (Material, Impression, 6); EBF (Material, Tooth Shade, Resin, 2); EJJ (Alloy, Amalgam, 2).
Has Coltene, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Coltene, Inc. Related entities may recall under other names.
Next steps
- See all 13 Coltene, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELW, Coltene, 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.