Sirona Dental CAD/CAM System With CEREC Chairside Software

Abutment, Implant, Dental, Endosseous

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Sirona Dental Cad/cam System With Cerec Chairside Software.

Pre-market Notification Details

Device IDK193408
510k NumberK193408
Device Name:Sirona Dental CAD/CAM System With CEREC Chairside Software
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Dentsply Sirona 221 West Philadelphia St., Suite 60W York,  PA  17401
ContactKarl Nittinger
CorrespondentKarl Nittinger
Dentsply Sirona 221 West Philadelphia St., Suite 60W York,  PA  17401
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-09
Decision Date2020-08-16

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