Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Redent Nova, Ltd. — 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) |
|---|---|---|---|---|---|
| K101172 | RDT3 HANDPIECE HEAD MODEL RDT3 | Redent Nova, Ltd. | 2010-07-27 | 92 | 0 |
| K100606 | VATEA ENDONTIC IRRIGATION SYSTEM | Redent Nova, Ltd. | 2010-05-28 | 86 | 0 |
| K092933 | SAF (SELF ADJUSTING FILE) | Redent-Nova , Ltd. | 2010-01-14 | 113 | 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