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510(k) K240754

N2 by Megagen Implant Co., Ltd. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2024
Date Received
March 20, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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