510(k) K172007

CamX Triton HD Proxi Head by Duerr Dental AG — Product Code NTK

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