Name: Predicase
Price: 199 USD

K-number	K103753
Device name	SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
Applicant	Sirona Dental Systems GmbH
Product code	GEX
Device class	Class II
Decision date	Feb 15, 2011
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER

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