K-number	K193577
Device name	SleepRight ProRx Custom Dental Guard
Applicant	Splintek, Inc.
Product code	OBR
Device class	Class U
Decision date	Jun 1, 2020
Decision	Substantially Equivalent
Regulation	—

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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SleepRight ProRx Custom Dental Guard

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