K-number	K231859
Device name	PrimmaArt
Applicant	Dentscare Ltda
Product code	EBG
Device class	Class II
Decision date	Nov 26, 2024
Decision	Substantially Equivalent
Regulation	872.3770

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Source

View the full FDA submission: accessdata.fda.gov

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PrimmaArt

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