K-number	K092591
Device name	ORTHOPANTOMOGRAPH OP30
Applicant	Instrumentarium Dental, Palodex Group OY
Product code	MUH
Device class	Class II
Decision date	Nov 20, 2009
Decision	Substantially Equivalent
Regulation	872.1800

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Source

View the full FDA submission: accessdata.fda.gov

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ORTHOPANTOMOGRAPH OP30

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