Home / 510(k) Clearances / K230523

510(k) K230523

s-Clean Link Abutment Narrow by Dentis Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2023
Date Received
February 27, 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 Dentis Co., Ltd.

  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K241065 — ChecQ (AC100) (March 21, 2025)
  • K233921 — Luvis Chair (LC700C) (September 6, 2024)
  • K241063 — s-Clean ScanHealing Abutment (July 25, 2024)
  • K240511 — Dentis s-Clean SQ-SL Fixture (May 20, 2024)
  • K233544 — MESHEET (February 22, 2024)
  • K230126 — Dentis s-Clean Regular Abutment (August 4, 2023)
  • K230307 — Dentis i-Clean System (July 11, 2023)
  • K230246 — Dentis s-Clean SQ-SL Narrow Implant System (May 25, 2023)
  • K230203 — Dentis I-FIX Abutment (May 3, 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)