Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
T-Plus Implant Tech. 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) |
|---|---|---|---|---|---|
| K190919 | ST Internal Implant System | T-Plus Implant Tech. Co., Ltd. | 2020-02-27 | 324 | 0 |
| K152787 | ST Internal Fixture System | T-Plus Implant Tech. Co., Ltd. | 2016-07-22 | 301 | 0 |
| K152786 | A Plus Internal Fixture System | T-Plus Implant Tech. Co., Ltd. | 2016-06-07 | 256 | 0 |
| K132992 | TI STAR IMPLANT SYSTEM | T-Plus Implant Tech. Co., Ltd. | 2013-12-18 | 85 | 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