FDA applicant
Dentall Co., Ltd.
FDA records 3 decisions for Dentall Co., Ltd. (Bucheon-Si, KR) from 2006 to 2017: 3 510(k) clearances. All are in product code EBZ (Activator, Ultraviolet, For Polymerization). 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 “Dentall Corp.”, “Dentall Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dentall Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dentall 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