Name: Predicase
Price: 199 USD

K-number	K103556
Device name	IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
Applicant	Ivoclar Vivadent, Inc.
Product code	EIH
Device class	Class II
Decision date	Apr 13, 2011
Decision	Substantially Equivalent
Regulation	872.6660

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Source

View the full FDA submission: accessdata.fda.gov

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IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)

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