Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medimecca Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K202039 | Honorst Implant System | Medimecca Co., Ltd. | 2020-09-25 | 64 | 0 |
| K160536 | Chaorum Implant System | Medimecca Co., Ltd. | 2017-01-05 | 314 | 0 |
| K131682 | UD IMPLANT SYSTEM | Medimecca Co., Ltd. | 2013-12-05 | 178 | 0 |
| K130221 | HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM | Medimecca Co., Ltd. | 2013-03-21 | 51 | 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