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510(k) K241003

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) by Hiossen, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2025
Date Received
April 12, 2024
Clearance Type
Abbreviated
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 Hiossen, Inc.

  • K251427 — EK MULTI ANGLED 30 ABUTMENT (January 29, 2026)
  • K240232 — EK D3.3 and Ultra Wide Implants (September 13, 2024)
  • K233389 — EK Digital Abutments (May 29, 2024)
  • K222636 — ET Abutment System (April 28, 2023)
  • K203360 — EK Implants and Abutments System (January 7, 2022)
  • K191751 — EM Provisional (December 16, 2019)
  • K191201 — EM SA Implant System (November 15, 2019)
  • K183242 — ET IV SA Dental Implants (May 21, 2019)
  • K180527 — IS3 (May 16, 2018)
  • K170421 — ET Hybrid Abutment (January 11, 2018)

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)