NBL · Laser, Fluorescence Caries Detection
Dental · 21 CFR 872.1745 · Class 2
Overview
| Product Code | NBL |
|---|---|
| Device Name | Laser, Fluorescence Caries Detection |
| Regulation | 21 CFR 872.1745 |
| Device Class | Class 2 |
| Review Panel | Dental |
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 (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | Apr 4, 2025 | SESE |
| K221275 | Qraycam PRO | AIOBIO Co., Ltd. | Sep 4, 2024 | SESE |
| K231722 | SmarTooth | Smartooth Co., Ltd. | May 1, 2024 | SESE |
| K223470 | C50 | Sopro | Dec 14, 2023 | SESE |
| K221249 | L1P-1F (TRIOS 5) | 3Shape TRIOS A/S | Sep 16, 2022 | SESE |
| K183471 | IC-WHCD100 (Inspire) | Good Doctors Co., Ltd. | Jul 2, 2020 | SESE |
| K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | May 3, 2018 | SESE |
| K170822 | Electronic Caries Detector | Ortek Therapeutics, Inc. | Sep 11, 2017 | SESE |
| K150672 | VistaCam iX Proof | Durr Dental AG | Jan 27, 2016 | SESE |
| K121685 | SOPROCARE | Sopro | Mar 12, 2013 | SESE |
| K112139 | THE CANARY SYSTEM | Quantum Dental Technologies, Inc. | Oct 26, 2012 | SESE |
| K111423 | CS 1600 INTRAORAL CAMERA | Carestream Health, Inc. | Mar 2, 2012 | SESE |
| K111321 | REMOTE VIEW SOFTWARE | Cariescan , Ltd. | May 17, 2011 | SESE |
| K093705 | FUORECAM | Therapeutic Technologies, Inc. | Apr 23, 2010 | SESE |
| K092583 | SOPROLIFE | Sopro | Jan 13, 2010 | SESE |
| K090598 | CARIESCAN PRO | Cariescan , Ltd. | Dec 15, 2009 | SESE |
| K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | Air Techniques, Inc. | Aug 18, 2009 | SESE |
| K063321 | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 | Neks Technologies, Inc. | Mar 30, 2007 | SESE |
| K051909 | DIAGNODENT | Kavo America | Oct 21, 2005 | SESE |
| K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | Kavo America Corporation | Aug 2, 2005 | SESE |
Top Applicants
- Sopro — 3 clearances
- 3Shape TRIOS A/S — 2 clearances
- Cariescan , Ltd. — 2 clearances
- Kavo America — 2 clearances
- Neks Technologies, Inc. — 2 clearances
