NTK · Class II · 21 CFR 872.1745

FDA Product Code NTK: Caries Detector, Laser Light, Transmission

Leading manufacturers include Kaltenbach & Voigt GmbH, Align Technology, Inc. and D4D Technologies, LLC.

12
Total
12
Cleared
153d
Avg days
2004
Since
Growing category - 3 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 122d recently vs 164d historically

FDA 510(k) Cleared Caries Detector, Laser Light, Transmission Devices (Product Code NTK)

12 devices
1–12 of 12
Cleared Aug 29, 2025
Primescan 2
K250771
Dentsply Sirona, Inc.
Dental · 169d
Cleared Aug 16, 2024
iTero Lumina™ Pro
K240573
Align Technology , Ltd.
Dental · 168d
Cleared Apr 29, 2022
TIA Tip, Cariosity, Transillumination Accessory Tip
K213482
D4D Technologies, LLC
Dental · 182d
Cleared Mar 20, 2020
iTero Element 5D
K193659
Align Technology, Inc.
Dental · 81d
Cleared Nov 23, 2019
DEXIS CariVu 3-in-1 by KaVo
K182712
Kaltenbach & Voigt GmbH
Dental · 422d

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 - 3 submissions in the last 24 months compared to 0 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 122 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 →