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510(k) K252004

enCore Night Guard by Encore Guards — Product Code OBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2025
Date Received
June 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Over-The-Counter
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

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