21 CFR 872.1745 — Laser, Fluorescence Caries Detection
Dental (DE) · Subpart B—Diagnostic Devices · § 872.1745
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NBL | Laser, Fluorescence Caries Detection | 2 | 23 | |
| NTK | Caries Detector, Laser Light, Transmission | 2 | 11 | 3rd Party |
Special Controls
NBL — Laser, Fluorescence Caries Detection
*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.
eCFR
NBL — Laser, Fluorescence Caries Detection
(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.
Ecfr Llm
NBL — Laser, Fluorescence Caries Detection
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.
De Novo Order DEN990002
NTK — Caries Detector, Laser Light, Transmission
*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.
eCFR
