Home / 510(k) Clearances / K160244

510(k) K160244

VARIOunite by Thommen Medical AG — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2016
Date Received
February 1, 2016
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 Thommen Medical AG

  • K171795 — Thommen Implant System (September 29, 2017)
  • K151984 — Thommen Milling Abutment for CAD/CAM (March 10, 2016)
  • K121334 — VARIOECO (August 14, 2012)
  • K111984 — SPI VARIO ANGLED ABUTMENT (November 10, 2011)
  • K102804 — SPI TITANIUM BASE FOR CAD/CAM (April 20, 2011)
  • K101798 — SPI VARIOMULTI ANGLED ABUTMENT (August 19, 2010)
  • K093615 — SPI DENTAL IMPLANT, ELEMENT (March 4, 2010)
  • K092248 — SPI CUSTOMIZABLE GINGIVA FORMER (September 25, 2009)
  • K090154 — SPI DENTAL IMPLANT INICELL (July 27, 2009)
  • K090153 — SPI VARIOMULTI ANGLED ABUTMENT (March 27, 2009)

Other clearances for product code NHA

  • K251434 — Healing Abutment System (March 4, 2026)
  • 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)