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510(k) K191890

Elos Accurate Customized Abutment by Elos Medtech Pinol A/S — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2020
Date Received
July 15, 2019
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.

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  • 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)
  • K192457 — Elos Accurate Customized Abutment (January 2, 2020)
  • K190299 — Elos Accurate® Customized Abutment (June 26, 2019)

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