Sirona Dental CAD/CAM System With InLab Software

Dental Abutment Design Software For Dental Laboratory

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 Inlab Software.

Pre-market Notification Details

Device IDK200191
510k NumberK200191
Device Name:Sirona Dental CAD/CAM System With InLab Software
ClassificationDental Abutment Design Software For Dental Laboratory
Applicant Dentsply Sirona 221 West Philadelphia St., Suite 60W York,  PA  17401
ContactKarl J. Nittinger
CorrespondentKarl J. Nittinger
Dentsply Sirona 221 West Philadelphia St., Suite 60W York,  PA  17401
Product CodePNP  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-27
Decision Date2020-08-19

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