Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
United Dental Resources Corporation · 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) |
|---|---|---|---|---|---|
| K201915 | GenesisZr 4Y+ (ST1100) Zirconia | United Dental Resources Corporation | 2021-02-23 | 228 | 0 |
| K201608 | GenesisZr UHT700 Zirconia | United Dental Resources Corporation | 2021-01-28 | 227 | 0 |
| K182642 | GenesisZr™ 4Y Zirconia | United Dental Resources Corporation | 2019-01-25 | 123 | 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