Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Denar Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
157 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925705 | ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM | Denar Corp. | 1992-12-28 | 46 | 0 |
| K924759 | COLLIMATOR LIGHT SOURCE | Denar Corp. | 1992-12-09 | 77 | 0 |
| K884845 | STERI-OSS | Denar Corp. | 1989-02-10 | 81 | 0 |
| K883373 | STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT | Denar Corp. | 1989-01-13 | 157 | 0 |
| K852802 | DENAR DENTAL IMPLANT | Denar Corp. | 1985-09-23 | 82 | 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