K-number	K061122
Device name	NIGHT GUARD
Applicant	Alpine Oral Care, LLC
Product code	MQC
Device class	Class U
Decision date	Mar 12, 2007
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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NIGHT GUARD

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