NTK · Caries Detector, Laser Light, Transmission
Dental · 21 CFR 872.1745 · Class 2
Overview
| Product Code | NTK |
|---|---|
| Device Name | Caries Detector, Laser Light, Transmission |
| Regulation | 21 CFR 872.1745 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.
Classification Rationale
Class II, subject to the following special controls:
Special Controls
*Classification.* Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter; (2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and (3) The labeling must include detailed use instructions with precautions that urge users to: (i) Read and understand all directions before using the device, (ii) Store probe tips under proper conditions, (iii) Properly sterilize the emitter-detector handpick before each use, and (iv) Properly maintain and handle the instrument in the specified manner and condition.
1. restrictions on the sale, distribution, and use of the device to prescription use in accordance with 21 CFR 801.109; 2. clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and 3. labeling that includes detailed use instructions with precautions that urge users to (i) read and understand all directions before using the device, (ii) store probe tips under proper conditions, (iii) properly sterilize the emitter-detector handpiece before each use, and (iv) properly maintain and handle the instrument in the specified manner and condition.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250771 | Primescan 2 | Dentsply Sirona, Inc. | Aug 29, 2025 | SESE |
| K240573 | iTero Lumina Pro | Align Technology , Ltd. | Aug 16, 2024 | SESE |
| K213482 | TIA Tip, Cariosity, Transillumination Accessory Tip | D4D Technologies, LLC | Apr 29, 2022 | SESE |
| K193659 | iTero Element 5D | Align Technology, Inc. | Mar 20, 2020 | SESE |
| K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | Nov 23, 2019 | SESE |
| K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | Nov 22, 2017 | SESE |
| K123402 | DIAGNOCAM | Kaltenbach & Voigt GmbH | Sep 24, 2013 | SESE |
| K071429 | TI2200 TRANSILLUMINATION CABLE | Kerr Corporation | Sep 10, 2007 | SESE |
| K062961 | MICROLUX TRANSILLUMINATOR | Addent, Inc. | Feb 8, 2007 | SESE |
| K060080 | DIAGNODENT 2190 WITH PERIODONTAL PROBE | Kavo Dental Corporation | Feb 8, 2006 | SESE |
| K043068 | DIFOTI USB 2.0 SYSTEM | Electro-Optical Sciences, Inc. | Dec 29, 2004 | SESE |
Top Applicants
- Kaltenbach & Voigt GmbH — 2 clearances
- Addent, Inc. — 1 clearance
- Align Technology , Ltd. — 1 clearance
- Align Technology, Inc. — 1 clearance
- D4D Technologies, LLC — 1 clearance
