Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intra-Lock International — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
242 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130140 | INTRA-LOCK OP DENTAL IMPLANT | Intra-Lock International | 2013-08-01 | 191 | 0 |
| K080598 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS | Intra-Lock International | 2008-05-21 | 79 | 0 |
| K070601 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM | Intra-Lock International | 2007-10-12 | 224 | 0 |
| K050970 | MILO DENTAL IMPLANT SYSTEM | Intra-Lock International | 2005-10-14 | 179 | 0 |
| K040205 | INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS | Intra-Lock International | 2004-03-22 | 52 | 0 |
| K031322 | INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS | Intra-Lock International | 2003-12-23 | 242 | 0 |
| K021915 | TRANSITIONAL IMPLANTS | Intra-Lock International | 2002-12-19 | 191 | 0 |
| K021322 | ENDOSSOUS IMPLANTS | Intra-Lock International | 2002-07-24 | 90 | 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