Den-Mat Corp.: FDA clearances and approvals
Den-Mat Corp. has 29 FDA 510(k) clearances (first 1977, latest 1999), across 21 product codes in 1 review panel. Median 510(k) review time: 41 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| DZN | Instruments, Dental Hand | 2 | 2 |
| EJS | Alloy, Other Noble Metal | 2 | 2 |
| ELL | Teeth, Porcelain | 2 | 2 |
| EMA | Cement, Dental | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| EAY | Light, Fiber Optic, Dental | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBP | Reliner, Denture, Over The Counter | 1 | 1 |
| EIE | Dam, Rubber | 1 | 1 |
Plus 11 more product codes.
Review panels
- Dental (29)
Most recent Den-Mat Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983106 | 1ST IMPRESSION | ELW | 1999-02-09 | 158 |
| K895731 | DEN-MAT CERINATE PORCELAIN | EIH | 1990-08-03 | 311 |
| K895269 | DEN-MAT LAMI-QUICK | ELL | 1990-02-22 | 183 |
| K881918 | LIGHT-CURED ZIONOMER CEMENT | EMA | 1988-07-15 | 67 |
| K875351 | DEN-MAT PORETCH (PORCELAIN ETCHANT) | ELL | 1988-03-18 | 78 |
| K872510 | DEN-MAT TENURE | EBF | 1987-08-24 | 61 |
| K870130 | DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM | ELR | 1987-02-19 | 38 |
| K864346 | REMBRANDT PORCELAIN TINTING KIT | EBF | 1987-01-07 | 64 |
| K862449 | DEN-MAT DENTIN LINK | EBF | 1986-07-22 | 25 |
| K860971 | DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) | KLE | 1986-03-25 | 21 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Den-Mat Corp..
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 Den-Mat Corp. have?
Den-Mat Corp. has 29 FDA 510(k) clearances (first 1977, latest 1999), across 21 product codes in 1 review panel.
How long does FDA take to clear Den-Mat Corp.'s 510(k)s?
The median time from FDA receipt to decision across Den-Mat Corp.'s cleared 510(k)s is 41 days.
What devices does Den-Mat Corp. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 4); DZN (Instruments, Dental Hand, 2); EJS (Alloy, Other Noble Metal, 2).
Has Den-Mat Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Den-Mat Corp. Related entities may recall under other names.
Next steps
- See all 29 Den-Mat Corp. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Den-Mat Corp.'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.