K-number	K212706
Device name	SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Applicant	Splintek, Inc.
Product code	OBR
Device class	Class U
Decision date	Dec 13, 2021
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard

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