Home / 510(k) Clearances / K231411

510(k) K231411

INNO SLA Submerged Hybrid Ti-Base System by Cowellmedi Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2023
Date Received
May 16, 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 Cowellmedi Co., Ltd.

  • K242287 — SFIT Abutment (September 16, 2025)
  • K241127 — INNO SLA Mini Plus® Implant System (December 27, 2024)
  • K232546 — Meta G UCLA Abutment (November 21, 2023)
  • K231395 — INNO SLA Submerged Narrow Implant System (October 18, 2023)
  • K211554 — InnoGenic Non-resorbable Membrane (February 24, 2023)
  • K201323 — INNO SLA Submerged Implant System (January 25, 2022)
  • K132242 — INNO SLA SUBMERGED IMPLANT SYSTEM (December 6, 2013)
  • K100850 — COWELL IMPLANT SYSTEM (December 20, 2010)
  • K090054 — ATLAS IMPLANT SYSTEM - WIDE PLUS (July 29, 2009)
  • K090049 — ATLAS IMPLANT SYSTEM- MINI PLUS (April 20, 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)