FDA applicant
Pointnix Co., Ltd.
FDA records 2 decisions for Pointnix Co., Ltd. (Great Neck, NY) from 2013 to 2023: 2 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and DZE (Implant, Endosseous, Root-Form). Its devices cite 2 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 Pointnix Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Pointnix Co., 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