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510(k) K223113

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments by Medentika GmbH — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2024
Date Received
October 3, 2022
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 Medentika GmbH

  • K253341 — Custom Abutments AS (December 23, 2025)
  • K242542 — Medentika CAD/CAM Abutments (April 22, 2025)
  • K201711 — CARES Screw - Retained Bars and Bridges (SRBB) (December 8, 2020)
  • K200906 — MINICONE Implant (October 16, 2020)
  • K191123 — Multi-unit Abutments (January 6, 2020)
  • K180564 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBase (January 7, 2019)
  • K170838 — Medentika CAD/CAM TiBases (September 15, 2017)
  • K150203 — Medentika CAD/CAM Abutments (October 23, 2015)
  • K142167 — MEDENTIKA ABUTMENT SYSTEM (February 20, 2015)

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)