Dentca, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dentca, Inc.” (first 2015, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 174 days. Since 2017 the median was 127 days, against 133 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 272 |
| 2016 | 0 | — |
| 2017 | 2 | 164 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 127 |
| 2021 | 0 | — |
| 2022 | 1 | 316 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 58 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dentca, Inc. took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 | 4 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| PZY | Additively Manufactured, Preformed, Resin Denture Tooth | 1 | 1 |
Review panels
- Dental (6)
Most recent Dentca, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261474 | DENTCA Tru Flexible | EBI | 2026-07-01 | 58 |
| K220042 | Dentca Base Premium, Dentca Base Hi-Impact | EBI | 2022-11-17 | 316 |
| K192806 | DENTCA Crown and Bridge | EBG | 2020-02-05 | 127 |
| K172398 | DENTCA DENTURE Teeth | PZY | 2017-11-22 | 106 |
| K162044 | Dentca Denture Base II | EBI | 2017-03-03 | 221 |
| K143033 | DENTCA DENTURE BASE | EBI | 2015-07-21 | 272 |
Recalls
openFDA lists no recalls under a recalling firm named Dentca, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dentca, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Dentca, Inc.” (first 2015, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dentca, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dentca, Inc. is 174 days. Since 2017: 127 days, versus 133 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dentca, Inc.?
The most frequent FDA product codes under this applicant name are EBI (Resin, Denture, Relining, Repairing, Rebasing, 4); EBG (Crown And Bridge, Temporary, Resin, 1); PZY (Additively Manufactured, Preformed, Resin Denture Tooth, 1).
Next steps
- See all 6 Dentca, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Dentca, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.