The following data is part of a premarket notification filed by Durr Dental Se with the FDA for Visionx 2.4.
| Device ID | K192743 |
| 510k Number | K192743 |
| Device Name: | VisionX 2.4 |
| Classification | System, Image Processing, Radiological |
| Applicant | Durr Dental SE Hopfigheimer Str. 17 Bietigheim-bissingen, DE 74321 |
| Contact | Oliver Lange |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E247E7300 | K192743 | 000 |