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510(k) K251569

Bone Screw by Osstem Implant Co., Ltd. — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2025
Date Received
May 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type

Other clearances by Osstem Implant Co., Ltd.

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  • K233194 — TS Abutment System (February 20, 2024)
  • K232220 — SS Abutment System (December 5, 2023)
  • K232012 — N1 (November 28, 2023)
  • K222778 — Osstem Implant System (September 23, 2023)
  • K221684 — Osstem Abutment System (September 8, 2022)
  • K212303 — T2 (September 21, 2021)
  • K210097 — Estar-Z (July 2, 2021)

Other clearances for product code DZL

  • K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (September 29, 2025)
  • K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN (June 27, 2025)
  • K233419 — GBR System (January 3, 2025)
  • K240321 — MP Pin flat without thread (36BMP000020/MP20) (October 17, 2024)
  • K233721 — KLS Martin Drill-Free MMF Screw (September 17, 2024)
  • K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws (August 24, 2023)
  • K222367 — SAVE GBR (March 23, 2023)
  • K201210 — The Micro Screw System, Micro Screw System Basic (October 8, 2021)
  • K201561 — Membrane Screws and Membrane Tacks (October 5, 2020)
  • K182881 — Bone Screw, Bone Tack (August 9, 2019)