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510(k) K210903

IS Multi Unit Abutment System by Neobiotech Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2021
Date Received
March 26, 2021
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 Neobiotech Co., Ltd.

  • K232528 — Protective Cap (April 30, 2024)
  • K232049 — IS-III active Short Implant (March 28, 2024)
  • K190849 — IS-III active System_S-narrow Type (August 14, 2019)
  • K181137 — IT-III active System (November 16, 2018)
  • K181138 — IS-III active System (October 3, 2018)
  • K181178 — S-mini active Fixture (July 24, 2018)
  • K173938 — IS-III HActive Fixture (May 24, 2018)
  • K160991 — Neo GBR System (January 10, 2017)
  • K120503 — CMI IMPLANT IS II ACTIVE (June 18, 2012)
  • K113554 — CMI IMPLANT IS SYSTEM (April 5, 2012)

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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)