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510(k) K232170

Ti Link Abutment by Izenimplant Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2024
Date Received
July 21, 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 Izenimplant Co., Ltd.

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  • K231557 — ZENEX FreeMilling & CCM Cast Abutment (August 24, 2023)
  • K230630 — ZENEX Implant System_Narrow (July 31, 2023)
  • K211090 — ZENEX Implant System (April 13, 2022)

Other clearances for product code NHA

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  • 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)