The following data is part of a premarket notification filed by Durr Dental Ag with the FDA for Dbswin And Vistaeasy Imaging Software.
| Device ID | K143290 |
| 510k Number | K143290 |
| Device Name: | DBSWIN And VistaEasy Imaging Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Durr Dental AG Hopfigheimer Strasse 17 Bietigheim-bissingen, DE D-74321 |
| Contact | Oliver Lange |
| Correspondent | Suzanne Lucas AIR TECHNIQUES, INC. 1295 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-17 |
| Decision Date | 2016-02-18 |
| Summary: | summary |