FDA applicant
Dentatus USA, Ltd.
FDA records 4 decisions for Dentatus USA, Ltd. (New York, NY) from 1996 to 2004: 4 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and ELS (Splint, Endodontic Stabilizing). Its devices cite 12 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dentatus USA, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dentatus USA, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dentatus USA, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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