Devices · Dentsply Sirona

CEREC Ortho Software

Dentsply Sirona is listed for CEREC Ortho Software (K171122). The FDA list gives January 11, 2018 as the date of the final decision. The lead panel is Dental, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PNN as “Orthodontic Software”: The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171122

Official FDA database record

Date of final decision

January 11, 2018

Company on the FDA list

Dentsply Sirona

Lead panel

Dental

Primary product code

PNN

openFDA device name for the code

Orthodontic Software

Device class

2

Regulation number

872.5470

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary