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510(k) K250743

Remvia NightGuard by Remvia — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2025
Date Received
March 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Prescription
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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