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510(k) K234142

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment by Megagen Implant Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2024
Date Received
December 29, 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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  • K240754 — N2 (March 21, 2024)
  • K233450 — MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Tem (January 22, 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)

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