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510(k) K212448

NightGuard Flex by Sprintray, Inc. — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2021
Date Received
August 5, 2021
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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