Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Impla-Med — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
199 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921854 | IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM | Impla-Med | 1992-10-27 | 193 | 0 |
| K902911 | TITANIUM/STAINLESS STEEL INSTRUMENTS | Impla-Med | 1990-09-06 | 66 | 0 |
| K902158 | TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP | Impla-Med | 1990-08-09 | 86 | 0 |
| K900061 | IMPLA-MED TITANIUM, IMPLANT DEVICES | Impla-Med | 1990-04-27 | 114 | 0 |
| K892124 | IMPLA-MED IMPLANT SYSTEM | Impla-Med | 1989-10-20 | 199 | 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