K-number	K191033
Device name	LunaGuard Nighttime Dental Protector
Applicant	Mckeon Products
Product code	OBR
Device class	Class U
Decision date	Aug 5, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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LunaGuard Nighttime Dental Protector

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