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510(k) K230103

Klockner Abutments by SOADCO, S.L. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2023
Date Received
January 13, 2023
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 SOADCO, S.L.

  • K243128 — Klockner Kits (December 18, 2024)
  • K173642 — KLOCKNER SURGICAL BOX (October 2, 2018)
  • K170022 — Klockner Vega TiBase for CEREC (November 16, 2017)
  • K153098 — KLOCKNER VEGA DENTAL IMPLANT SYSTEM (April 8, 2016)
  • K151194 — KLOCKNER DENTAL IMPLANT ABUTMENTS (II) (January 29, 2016)
  • K122988 — KLOCKNER DENTAL IMPLANT ABUTMENTS (July 19, 2013)
  • K082200 — KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 (November 25, 2008)
  • K080224 — KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL (July 3, 2008)
  • K052654 — KLOCKNER DENTAL IMPLANT, MODEL S3M (January 30, 2006)
  • K010132 — KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 (June 4, 2002)

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  • K251515 — Solidex® Ti-Links and Screws (February 10, 2026)
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  • 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)