FDA Product Code NTK: Caries Detector, Laser Light, Transmission
Leading manufacturers include Kaltenbach & Voigt GmbH, Align Technology , Ltd. and Electro-Optical Sciences, Inc..
12
Total
12
Cleared
153d
Avg days
2004
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
99d
recently vs 164d historically
FDA 510(k) Cleared Caries Detector, Laser Light, Transmission Devices (Product Code NTK)
12 devices
Cleared
Jul 02, 2026
iTero Lumina™ Pro
Align Technology , Ltd.
Dental
29d
Cleared
Aug 29, 2025
Primescan 2
Dentsply Sirona, Inc.
Dental
169d
Cleared
Aug 16, 2024
iTero Lumina™ Pro
Align Technology , Ltd.
Dental
168d
Cleared
Apr 29, 2022
TIA Tip, Cariosity, Transillumination Accessory Tip
D4D Technologies, LLC
Dental
182d
Cleared
Mar 20, 2020
iTero Element 5D
Align Technology, Inc.
Dental
81d
Cleared
Nov 23, 2019
DEXIS CariVu 3-in-1 by KaVo
Kaltenbach & Voigt GmbH
Dental
422d
Cleared
Nov 22, 2017
CamX Triton HD Proxi Head
Duerr Dental AG
Dental
142d
Cleared
Sep 24, 2013
DIAGNOCAM
Kaltenbach & Voigt GmbH
Dental
323d
Cleared
Sep 10, 2007
TI2200 TRANSILLUMINATION CABLE
Kerr Corporation
Dental
110d
Cleared
Dec 29, 2004
DIFOTI USB 2.0 SYSTEM
Electro-Optical Sciences, Inc.
Dental
51d
About Product Code NTK - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code NTK since 2004, with 12 receiving FDA clearance (average review time: 153 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - NTK Product Code
Recent submissions under NTK have taken an average of 99 days to reach a decision - down from 164 days historically, suggesting improved FDA processing for this classification.
NTK devices are reviewed by the Dental panel. Browse all Dental devices →