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510(k) K191033

LunaGuard Nighttime Dental Protector by Mckeon Products — Product Code OBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2019
Date Received
April 18, 2019
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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