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510(k) K222778

Osstem Implant System by Osstem Implant Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2023
Date Received
September 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Osstem Implant Co., Ltd.

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  • K251569 — Bone Screw (August 13, 2025)
  • K242521 — Estar-ZE (November 20, 2024)
  • K233806 — T2 Plus (September 6, 2024)
  • K233194 — TS Abutment System (February 20, 2024)
  • K232220 — SS Abutment System (December 5, 2023)
  • K232012 — N1 (November 28, 2023)
  • K221684 — Osstem Abutment System (September 8, 2022)
  • K212303 — T2 (September 21, 2021)
  • K210097 — Estar-Z (July 2, 2021)

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