K-number	K132109
Device name	ENAMELAST
Applicant	Ultradent Products Inc. / Oratech, LLC
Product code	LBH
Device class	Class II
Decision date	Nov 1, 2013
Decision	Substantially Equivalent
Regulation	872.3260

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Source

View the full FDA submission: accessdata.fda.gov

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ENAMELAST

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