The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Orthophos S.
| Device ID | K191616 |
| 510k Number | K191616 |
| Device Name: | Orthophos S |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Karl Nittinger |
| Correspondent | Karl Nittinger Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2019-07-16 |