510(k) K143290
K143290 is an FDA 510(k) premarket notification submitted by Durr Dental AG for the device "DBSWIN and VistaEasy Imaging Software". The FDA issued a decision of Substantially Equivalent on February 18, 2016. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Durr Dental AG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2016
- Date Received
- November 17, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type