Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Impladent , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
1060 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | Impladent , Ltd. | 2014-12-18 | 170 | 0 |
| K090794 | OSTEOTAPE | Impladent , Ltd. | 2009-12-10 | 261 | 0 |
| K033098 | OSTEOGEN SBRG | Impladent , Ltd. | 2004-04-27 | 211 | 0 |
| K982925 | LAMINOSS DENTAL IMPLANT | Impladent , Ltd. | 1999-05-18 | 271 | 0 |
| K933705 | LAMINOSS DENTAL IMPLANT | Impladent , Ltd. | 1996-06-24 | 1060 | 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