Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotem Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
329 daysmedian FDA review time
345 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222142 | BR SLA Type Implant System | Biotem Co., Ltd. | 2023-06-24 | 339 | 0 |
| K222144 | IR SLA Type Implant System | Biotem Co., Ltd. | 2023-06-14 | 329 | 0 |
| K190641 | AR_N SLA Type Implant System | Biotem Co., Ltd. | 2020-02-21 | 345 | 0 |
| K171179 | BR Type Implant System | Biotem Co., Ltd. | 2018-02-09 | 291 | 0 |
| K171297 | AR_N Type Implant System | Biotem Co., Ltd. | 2018-01-31 | 274 | 0 |
| K171185 | IR Type Implant System | Biotem Co., Ltd. | 2017-12-01 | 221 | 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