510(k) K172007
K172007 is an FDA 510(k) premarket notification submitted by Duerr Dental AG for the device "CamX Triton HD Proxi Head". The FDA issued a decision of Substantially Equivalent on November 22, 2017. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. Duerr Dental AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2017
- Date Received
- July 3, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Transmission Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type