Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vacudent Sales 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) |
|---|---|---|---|---|---|
| K800575 | VACUDENT LUMIX 70 | Vacudent Sales Corp. | 1980-05-20 | 67 | 0 |
| K800574 | VACUDENT LUMIX 65 | Vacudent Sales Corp. | 1980-05-20 | 67 | 0 |
| K800520 | DENTAL STOOLS, #'S P2212, P1121, ETC. | Vacudent Sales Corp. | 1980-03-18 | 12 | 0 |
| K781882 | MODULAT DENTAL SYSTEMS | Vacudent Sales Corp. | 1978-12-28 | 65 | 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