K-number	K080514
Device name	PECD-01 AND PECD QUICK-01
Applicant	3M Espe AG Dental Products
Product code	ELW
Device class	Class II
Decision date	Mar 26, 2008
Decision	Substantially Equivalent
Regulation	872.3660

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Source

View the full FDA submission: accessdata.fda.gov

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PECD-01 AND PECD QUICK-01

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