Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Warantec 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) |
|---|---|---|---|---|---|
| K221972 | Warantec Custom Abutment | Warantec Co., Ltd. | 2023-10-02 | 454 | 0 |
| K221969 | IU Implant System Abutment | Warantec Co., Ltd. | 2023-05-12 | 311 | 0 |
| K172345 | IU Implant System | Warantec Co., Ltd. | 2018-06-18 | 320 | 0 |
| K081748 | ONEPLANT DENTAL IMPLANT SYSTEM | Warantec Co., Ltd. | 2009-03-27 | 281 | 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