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510(k) K241170

Dynamic TiBase; TRI Screws by Talladium España, SL — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2024
Date Received
April 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 Talladium España, SL

  • K243732 — Multi-Unit DAS System (January 29, 2026)
  • K243425 — Guided DAS Surgical Kit (July 22, 2025)
  • K243530 — Dynamic TiBase (May 30, 2025)
  • K231559 — Multi-Unit DAS System (November 17, 2023)
  • K232151 — Dynamic TiBase (October 17, 2023)
  • K212108 — Dynamic TiBase (September 24, 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)