The following data is part of a premarket notification filed by Duerr Dental Ag with the FDA for Dbswin And Vistaeasy Imaging Software.
| Device ID | K161444 |
| 510k Number | K161444 |
| Device Name: | DBSWIN And VistaEasy Imaging Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Duerr Dental AG Hoepfigheimer Str. 17 Bietigheim-bissingen, DE D-74321 |
| Contact | Oliver Lange |
| Correspondent | Suzanne Lucas Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-25 |
| Decision Date | 2016-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E247E72000 | K161444 | 000 |