The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Navina Smart System, Navina Classic System.
| Device ID | K190977 |
| 510k Number | K190977 |
| Device Name: | Navina Smart System, Navina Classic System |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| 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 | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2019-11-22 |