Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diamodent · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K034022 | UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES | Diamodent | 2004-01-30 | 32 | 0 |
| K010619 | UCLA AND UNIVERSAL ABUTMENTS | Diamodent | 2001-09-28 | 211 | 0 |
| K993129 | UCLA/UNIVERSAL ABUTMENT | Diamodent | 2000-03-28 | 190 | 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