Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Denpac Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873373 | SINTERLOY | Denpac Corp. | 1987-10-27 | 64 | 0 |
| K831484 | COMPOSI-GLAZE | Denpac Corp. | 1983-07-28 | 80 | 0 |
| K831483 | SAVE-A-BAKE PORCELAIN POLISH | Denpac Corp. | 1983-07-28 | 80 | 0 |
| K791160 | DENTALEEN | Denpac Corp. | 1980-02-21 | 244 | 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