FDA applicant
Dror Orthodesign, Ltd.
FDA records 2 decisions for Dror Orthodesign, Ltd. (Jerusalem, IL) from 2020 to 2026: 2 510(k) clearances. All are in product code NXC (Aligner, Sequential). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Dror Orthodesign”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dror Orthodesign, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Dror Orthodesign, 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