FDA applicant
Redent Nova, Ltd.
FDA records 3 decisions for Redent Nova, Ltd. (Washington, DC) in 2010: 3 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and NYL (Handpiece, Air-Powered, Root Canal Irrigation). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Redent-Nova , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Redent Nova, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2010
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Redent Nova, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report