K-number	K151933
Device name	BRX PRO Bruxism Guard
Applicant	12th Man Technologies, Inc.
Product code	MQC
Device class	Class U
Decision date	Dec 10, 2015
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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BRX PRO Bruxism Guard

Everything you need for a 510(k) submission. Nothing you don't.