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510(k) K241972

BLUEDIAMOND IMPLANT by Megagen Implant Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2024
Date Received
July 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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