K-number	K062828
Device name	MOUTHGUARD AND ALIGNER MATERIALS
Applicant	Dentsply Intl., Inc.
Product code	MQC
Device class	Class U
Decision date	Nov 27, 2006
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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MOUTHGUARD AND ALIGNER MATERIALS

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