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510(k) K241575

Straumann® Anatomic Healing Abutments XC (AHA) by Straumann USA, LLC — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 11, 2024
Date Received
June 3, 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 Straumann USA, LLC

  • K203753 — Straumann Surgical Cassettes (July 29, 2021)
  • K202942 — Straumann 4 mm Short Implants (February 8, 2021)
  • K192401 — Straumann Screw-Retained Abutments (April 6, 2020)
  • K190662 — MRI Compatibility for Existing Straumann Dental Implant Systems (June 17, 2019)
  • K171784 — Straumann Dental Implant System (January 19, 2018)
  • K162890 — BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments (March 8, 2017)
  • K151590 — Straumann RN Gold Abutment for Bridge (March 4, 2016)
  • K151328 — PURE Ceramic Implants (January 11, 2016)
  • K150899 — Straumann CARES Titanium Alloy (TAN) Abutment (September 16, 2015)
  • K151324 — Straumann Variobase for CEREC (September 11, 2015)

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)