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510(k) K241722

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment by Elos Medtech Pinol A/S — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2024
Date Received
June 14, 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 Elos Medtech Pinol A/S

  • K251497 — Elos Accurate Hybrid Base (October 16, 2025)
  • K242025 — Elos Accurate® Hybrid Base™ (December 10, 2024)
  • K231307 — Elos Accurate Customized Abutment (December 21, 2023)
  • K230317 — Elos Accurate Hybrid Base (September 1, 2023)
  • K222044 — Elos Accurate Customized Abutment (November 30, 2022)
  • K201860 — Elos Accurate Hybrid Base (February 19, 2021)
  • K191919 — Elos Accurate Hybrid Base (February 10, 2020)
  • K191890 — Elos Accurate Customized Abutment (February 6, 2020)
  • K192457 — Elos Accurate Customized Abutment (January 2, 2020)
  • K190299 — Elos Accurate® Customized Abutment (June 26, 2019)

Other clearances for product code NHA

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  • 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)