FDA applicant
Impladent, Ltd.
FDA records 11 decisions for Impladent, Ltd. (Hollis, NY) from 1980 to 2014: 11 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and LYC (Bone Grafting Material, Synthetic). Its devices cite 12 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Impladent”, “Impladent, S.L.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Impladent, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Impladent, 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