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510(k) K242542

Medentika CAD/CAM Abutments by Medentika GmbH — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2025
Date Received
August 26, 2024
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

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  • 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)

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  • 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)