K-number	K210940
Device name	LuxaPrint Ortho Plus
Applicant	Dmg Digital Enterprises SE
Product code	MQC
Device class	Class U
Decision date	Sep 3, 2021
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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LuxaPrint Ortho Plus

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