510(k) K150672
K150672 is an FDA 510(k) premarket notification submitted by Durr Dental AG for the device "VistaCam iX Proof". The FDA issued a decision of Substantially Equivalent on January 27, 2016. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. Durr Dental AG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2016
- Date Received
- March 16, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light-Induced Fluorescence Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type