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510(k) K231426

8plant Implant System by Hoowon Edi Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2024
Date Received
May 17, 2023
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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