Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Promimic AB · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano S | Promimic AB | 2026-05-12 | 257 | 0 |
| K101225 | PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-100 | Promimic AB | 2011-01-25 | 267 | 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