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510(k) K201323

INNO SLA Submerged Implant System by Cowellmedi Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2022
Date Received
May 18, 2020
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)
  • K231411 — INNO SLA Submerged Hybrid Ti-Base System (December 20, 2023)
  • 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)
  • 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)

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  • 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)