Name: Predicase
Price: 199 USD

K-number	K161042
Device name	CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
Applicant	Kuraray Noritake Dental, Inc.
Product code	KLE
Device class	Class II
Decision date	Oct 25, 2016
Decision	Substantially Equivalent
Regulation	872.3200

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

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