Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocetec 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) |
|---|---|---|---|---|---|
| K231635 | A-Line Advanced | Biocetec Co., Ltd. | 2023-06-06 | 1 | 0 |
| K190871 | Bio-TackS Orthodontic Mini Implant | Biocetec Co., Ltd. | 2020-01-17 | 289 | 0 |
| K182193 | S-Line | Biocetec Co., Ltd. | 2019-01-22 | 161 | 0 |
| K163467 | C-Line Orthodontic Ceramic Bracket | Biocetec Co., Ltd. | 2017-06-14 | 184 | 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