K-number	K193408
Device name	Sirona Dental CAD/CAM System with CEREC Chairside Software
Applicant	Dentsply Sirona
Product code	NHA
Device class	Class II
Decision date	Aug 16, 2020
Decision	Substantially Equivalent
Regulation	872.3630

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Source

View the full FDA submission: accessdata.fda.gov

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Sirona Dental CAD/CAM System with CEREC Chairside Software

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