Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Demetron Research Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955763 | OPTILUX 400 | Demetron Research Corp. | 1996-01-04 | 15 | 0 |
| K822642 | OPTILUX & VISILUX DENTAL PHOTO LAMP | Demetron Research Corp. | 1982-09-14 | 13 | 0 |
| K781345 | ULTRAFILL- ULTRABOUND | Demetron Research Corp. | 1978-08-31 | 24 | 0 |
| K780518 | ULTRANOVAR, DENTAL U.V. CURING LAMP | Demetron Research Corp. | 1978-04-28 | 28 | 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