FDA applicant
Dentmate Technology Co., Ltd.
FDA records 4 decisions for Dentmate Technology Co., Ltd. (New Taipei, TW) from 2008 to 2022: 4 510(k) clearances. All are in product code EBZ (Activator, Ultraviolet, For Polymerization). Its devices cite 1 predicate, 1 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 Dentmate Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Dentmate Technology 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