K-number	K150492
Device name	Ora-GUARD Dental Grind Guard
Applicant	Bite Tech, Inc.
Product code	OBR
Device class	Class U
Decision date	Feb 19, 2016
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Ora-GUARD Dental Grind Guard

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