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Osstem Implant Co., Ltd.

FDA 510(k) & PMA Approved Devices — 31 products

Total Devices31
Categories10
Latest FDA decision2026-03-04
TypeNumberDevice NameCodeDateActions
510(k) K251434 Healing Abutment SystemNHA2026-03-04 View
510(k) K251569 Bone ScrewDZL2025-08-13 View
510(k) K242521 Estar-ZEEIH2024-11-20 View
510(k) K233806 T2 PlusOAS2024-09-06 View
510(k) K233194 TS Abutment SystemNHA2024-02-20 View
510(k) K232220 SS Abutment SystemNHA2023-12-05 View
510(k) K232012 N1EHD2023-11-28 View
510(k) K222778 Osstem Implant SystemDZE2023-09-23 View
510(k) K221684 Osstem Abutment SystemNHA2022-09-08 View
510(k) K212303 T2OAS2021-09-21 View
510(k) K210097 Estar-ZEIH2021-07-02 View
510(k) K210041 HySil Plus Impression MaterialsELW2021-03-18 View
510(k) K192941 HySil Super Fast Impression MaterialsELW2020-01-30 View
510(k) K183347 K3EIA2019-09-04 View
510(k) K183475 T1-CS, T1-COAS2019-08-30 View
510(k) K182881 Bone Screw, Bone TackDZL2019-08-09 View
510(k) K182091 Osstem Abutment SystemNHA2019-07-12 View
510(k) K181854 OssBuilder SystemDZL2019-05-07 View
510(k) K181236 HySil Impression MaterialsELW2018-09-13 View
510(k) K172354 OssBuilder SystemJEY2018-03-26 View

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