Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Lok Intl., Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060285 | BONEGEN - TR | Bio-Lok Intl., Inc. | 2006-03-16 | 41 | 0 |
| K041136 | MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFA | Bio-Lok Intl., Inc. | 2004-10-22 | 175 | 0 |
| K032454 | SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) | Bio-Lok Intl., Inc. | 2004-03-04 | 206 | 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