Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Odontit S.A. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123876 | SYNERGY | Odontit S.A. | 2014-05-22 | 521 | 0 |
| K072917 | JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM | Odontit S.A. | 2008-01-14 | 94 | 0 |
| K961631 | ODONT HEX SYSTEM | Odontit S.A. | 1997-05-12 | 378 | 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