K-number	K222424
Device name	Protect-It Custom Fit Dental Guard
Applicant	Doc Brands, Inc.
Product code	OBR
Device class	Class U
Decision date	Oct 7, 2022
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Protect-It Custom Fit Dental Guard

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