The following data is part of a premarket notification filed by Dürr Dental Se with the FDA for Scanx Edge.
| Device ID | K202633 |
| 510k Number | K202633 |
| Device Name: | ScanX Edge |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Dürr Dental SE Höpfigheimer Str. 17 Bietigheim-bissingen, DE 74321 |
| Contact | Oliver Lange |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-11 |
| Decision Date | 2020-10-07 |