Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Polident D.O.O., Dental Products Industry · 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) |
|---|---|---|---|---|---|
| K153546 | PINK CAD/CAM disc | Polident D.O.O., Dental Products Industry | 2016-09-28 | 292 | 0 |
| K112967 | PMMA CAD/CAM DISC | Polident D.O.O., Dental Products Industry | 2012-08-28 | 328 | 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