The following data is part of a premarket notification filed by Duerr Dental Ag with the FDA for Scanx Intraoral View.
| Device ID | K170733 |
| 510k Number | K170733 |
| Device Name: | ScanX Intraoral View |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Duerr Dental AG Hopfigheimer Strasse 17 Bietigheim-bissingen, DE D-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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-10 |
| Decision Date | 2017-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E247G87000 | K170733 | 000 |
| E247G8300 | K170733 | 000 |
| E247G86000 | K170733 | 000 |
| E247G85000 | K170733 | 000 |