The following data is part of a premarket notification filed by Durr Dental Se with the FDA for Visionx 3.0.
| Device ID | K213326 |
| 510k Number | K213326 |
| Device Name: | VisionX 3.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Durr Dental SE Hopfigheimer Str. 17 Bietigheim-bissingen, DE 74321 |
| Contact | Oliver Lange |
| Correspondent | Daniel Kamm Kamm & Assosciates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-05 |
| Decision Date | 2021-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E247E7300A10 | K213326 | 000 |