The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Cerec Ortho Software.
| Device ID | K171122 |
| 510k Number | K171122 |
| Device Name: | CEREC Ortho Software |
| Classification | Orthodontic Software |
| Applicant | Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Karl J. Nittinger |
| Correspondent | Karl J. Nittinger Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-17 |
| Decision Date | 2018-01-11 |
| Summary: | summary |