Name: Predicase
Price: 199 USD

K-number	K101540
Device name	GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
Applicant	Novocol Inc. Dba Septodont and Confi-Dental Produc
Product code	EBF
Device class	Class II
Decision date	Oct 29, 2010
Decision	Substantially Equivalent
Regulation	872.3690

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Source

View the full FDA submission: accessdata.fda.gov

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GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE

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