Home / 510(k) Clearances / K232220

510(k) K232220

SS Abutment System by Osstem Implant Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2023
Date Received
July 26, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by Osstem Implant Co., Ltd.

  • K251434 — Healing Abutment System (March 4, 2026)
  • 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)
  • 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 NHA

  • K251434 — Healing Abutment System (March 4, 2026)
  • K251515 — Solidex® Ti-Links and Screws (February 10, 2026)
  • K251427 — EK MULTI ANGLED 30 ABUTMENT (January 29, 2026)
  • K243732 — Multi-Unit DAS System (January 29, 2026)
  • K253253 — IPDmilled Blanks (January 22, 2026)
  • K253315 — Straumann Variobase Abutments XC for Bridge/Bar (January 22, 2026)
  • K252727 — Neodent InLab Validated Workflow (January 7, 2026)
  • K253341 — Custom Abutments AS (December 23, 2025)
  • K253312 — OrangeCAD Med Abutments (December 23, 2025)
  • K252320 — SIMDA Abutments (December 18, 2025)