510(k) K172007

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

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
Caries Detector, Laser Light, Transmission
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type