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Izenimplant Co., Ltd.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories2
Latest FDA decision2026-03-16
TypeNumberDevice NameCodeDateActions
510(k) K253334 ZENEX Implant System_Short (R-System)DZE2026-03-16 View
510(k) K252585 ZENEX Implant System_R-SystemDZE2026-01-08 View
510(k) K240560 ZENEX Implant System_LongDZE2024-10-30 View
510(k) K232170 Ti Link AbutmentNHA2024-01-12 View
510(k) K233163 ZENEX Implant System_ShortDZE2023-12-19 View
510(k) K231557 ZENEX FreeMilling & CCM Cast AbutmentNHA2023-08-24 View
510(k) K230630 ZENEX Implant System_NarrowDZE2023-07-31 View
510(k) K211090 ZENEX Implant SystemDZE2022-04-13 View