The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Navina Classic System.
| Device ID | K170487 |
| 510k Number | K170487 |
| Device Name: | 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 | 2017-02-17 |
| Decision Date | 2017-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07392532198533 | K170487 | 000 |
| 07392532198502 | K170487 | 000 |
| 07392532198472 | K170487 | 000 |
| 07392532198434 | K170487 | 000 |
| 07392532198410 | K170487 | 000 |
| 07392532179273 | K170487 | 000 |
| 07392532198380 | K170487 | 000 |