Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentca, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
221 daysmedian FDA review time
316 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | 2026-07-01 | 58 | 0 |
| K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. | 2022-11-17 | 316 | 0 |
| K192806 | DENTCA Crown and Bridge | Dentca, Inc. | 2020-02-05 | 127 | 0 |
| K172398 | DENTCA DENTURE Teeth | Dentca, Inc. | 2017-11-22 | 106 | 0 |
| K162044 | Dentca Denture Base II | Dentca, Inc. | 2017-03-03 | 221 | 0 |
| K143033 | DENTCA DENTURE BASE | Dentca, Inc. | 2015-07-21 | 272 | 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