Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Impladent — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
1058 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923310 | OSTEOGEN (HA RESORB) | Impladent | 1995-05-31 | 1058 | 0 |
| K881662 | EXPANDED CLAIMES TO OSTEOGEN(R) | Impladent | 1988-09-01 | 139 | 0 |
| K843398 | OSTEOGEN | Impladent | 1984-12-27 | 120 | 0 |
| K812321 | HYDROXI-FLEX IMPLANT | Impladent | 1981-10-29 | 73 | 0 |
| K792663 | FLEXI-CUP IMPLANT | Impladent | 1980-01-09 | 14 | 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