K-number	K091660
Device name	CUSTOM COMFORT NIGHTGUARD VERSION 2
Applicant	Den Tek Oral Care, Inc.
Product code	OBR
Device class	Class U
Decision date	Jun 12, 2009
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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CUSTOM COMFORT NIGHTGUARD VERSION 2

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