Name: Predicase
Price: 199 USD

K-number	K111975
Device name	CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
Applicant	Kuraray Medical, Inc.
Product code	KLE
Device class	Class II
Decision date	Oct 14, 2011
Decision	Substantially Equivalent
Regulation	872.3200

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Source

View the full FDA submission: accessdata.fda.gov

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CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK

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