FDA Product Code NTK: Caries Detector, Laser Light, Transmission
Leading manufacturers include Align Technology , Ltd. and Dentsply Sirona, Inc..
FDA 510(k) Cleared Caries Detector, Laser Light, Transmission Devices (Product Code NTK)
About Product Code NTK - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code NTK since 2004, with 11 receiving FDA clearance (average review time: 164 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for NTK submissions have been consistent, averaging 169 days recently vs 164 days historically.
NTK devices are reviewed by the Dental panel. Browse all Dental devices →