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510(k) K242030

MegaGen Dental Implant Abutment by Megagen Implant Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2025
Date Received
July 11, 2024
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.

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  • K211556 — N2 (April 5, 2023)
  • K211812 — BLUEDIAMOND IMPLANT, Abutment Screw (January 6, 2023)

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  • K253312 — OrangeCAD Med Abutments (December 23, 2025)
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