CEREC Ortho Software

Orthodontic Software

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Cerec Ortho Software.

Pre-market Notification Details

Device IDK171122
510k NumberK171122
Device Name:CEREC Ortho Software
ClassificationOrthodontic Software
Applicant Dentsply Sirona 221 West Philadelphia Street, Suite 60W York,  PA  17401
ContactKarl J. Nittinger
CorrespondentKarl J. Nittinger
Dentsply Sirona 221 West Philadelphia Street, Suite 60W York,  PA  17401
Product CodePNN  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-17
Decision Date2018-01-11
Summary:summary

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