Name: Predicase
Price: 199 USD

K-number	K213609
Device name	NOVA RESIN dual cure, self adhesive resin cement
Applicant	Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Product code	EMA
Device class	Class II
Decision date	Aug 9, 2022
Decision	Substantially Equivalent
Regulation	872.3275

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Source

View the full FDA submission: accessdata.fda.gov

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NOVA RESIN dual cure, self adhesive resin cement

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