K-number	K180933
Device name	DenTek Ultimate Dental Guard
Applicant	Medtech Products, Inc.
Product code	OBR
Device class	Class U
Decision date	Sep 17, 2018
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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DenTek Ultimate Dental Guard

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