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510(k) K233450

MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw by Megagen Implant Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2024
Date Received
October 20, 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 Megagen Implant Co., Ltd.

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  • K241972 — BLUEDIAMOND IMPLANT (December 27, 2024)
  • K234142 — TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (September 18, 2024)
  • K240754 — N2 (March 21, 2024)
  • K231967 — ARi ExCon Implant System (December 7, 2023)
  • K223909 — R2GATE Lite TM (October 20, 2023)
  • K230618 — MegaGen Dental Implant Systems Portfolio - MR Conditional (October 11, 2023)
  • K223339 — Bone Chamber Implant (July 18, 2023)
  • K211556 — N2 (April 5, 2023)
  • K211812 — BLUEDIAMOND IMPLANT, Abutment Screw (January 6, 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)