Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intra-Lock International, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
278 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171831 | Intra-Lock Bone Fixation System | Intra-Lock International, Inc. | 2017-10-26 | 128 | 0 |
| K133613 | INTRA-LOCK DENTAL IMPLANTS | Intra-Lock International, Inc. | 2014-03-20 | 115 | 0 |
| K111199 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED | Intra-Lock International, Inc. | 2011-08-08 | 102 | 0 |
| K103194 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM | Intra-Lock International, Inc. | 2011-04-21 | 174 | 0 |
| K082419 | REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 | Intra-Lock International, Inc. | 2009-05-27 | 278 | 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