Home / 510(k) Clearances / K193193

510(k) K193193

Telio CAD Abutment Solutions- extra systems by Ivoclar Vivadent, AG — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2020
Date Received
November 19, 2019
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 Ivoclar Vivadent, AG

  • K253953 — IPS e.max Zirconia (March 10, 2026)
  • K252450 — Adhese 2 (March 5, 2026)
  • K233995 — Ivotion Base Print (February 23, 2024)
  • K210804 — Adhese Universal DC, Cention Primer (June 7, 2022)
  • K211916 — IPS e.max One (August 20, 2021)
  • K191453 — Cervitec F (February 11, 2020)
  • K191448 — Barrier Sleeves (October 8, 2019)
  • K191382 — IPS e.max CAD Abutment Solutions- extra systems (August 26, 2019)
  • K190339 — Helioseal F Plus (July 29, 2019)
  • K190272 — Bluephase PowerCure (July 3, 2019)

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)