Home / 510(k) Clearances / K240208

510(k) K240208

DESS Dental Smart Solutions by Terrats Medical SL — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2024
Date Received
January 25, 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 Terrats Medical SL

  • K251547 — DESS Dental Smart Solutions (October 31, 2025)
  • K252384 — DESS® Dental Smart Solutions (October 23, 2025)
  • K251280 — DESS® Dental Implants (July 23, 2025)
  • K250639 — DESS Dental Smart Solutions (May 22, 2025)
  • K243212 — DESS Dental Smart Solutions (February 14, 2025)
  • K242340 — DESS Dental Smart Solutions (November 5, 2024)
  • K240982 — DESS Dental Smart Solutions (August 26, 2024)
  • K233316 — DESS Dental Smart Solutions (January 5, 2024)
  • K231434 — DESS Dental Smart Solutions (August 14, 2023)
  • K230143 — DESS Dental Smart Solutions (April 13, 2023)

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)