K-number	K082594
Device name	REMESENSE
Applicant	Remedent NV
Product code	LBH
Device class	Class II
Decision date	Mar 19, 2009
Decision	Substantially Equivalent
Regulation	872.3260

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Source

View the full FDA submission: accessdata.fda.gov

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REMESENSE

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