Spectra Fluorescence Caries Detection Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090169 FDA 510(k)
- FDA Product Code
- NBL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1745 FDA 510(k)
- Regulation Number
- 872.1745 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Spectra Fluorescence Caries Detection Device is a laser-based fluorescence caries detection system designed to identify dental caries, plaque, and calculus. It employs fluorescence technology to enhance early detection of tooth decay and other sub-surface dental issues, improving diagnostic accuracy and patient care.
This device is intended for use in dental settings and is supplied as a reusable instrument. It operates under non-invasive principles and provides visual and numerical feedback to assist in treatment planning. Authorized under FDA 510K clearance (K090169), it adheres to regulatory standards for Class II medical devices in dental diagnostics, ensuring compliance with safety and performance requirements.
Frequently asked questions
How does the Spectra Fluorescence Caries Detection Device help improve early detection of dental issues compared to traditional methods?
The Spectra Fluorescence Caries Detection Device uses laser-based fluorescence technology to detect dental caries, plaque, and calculus at an early stage by identifying subtle changes in tooth structure. Unlike traditional methods like visual inspection or X-rays, it provides real-time visual and numerical feedback, enhancing diagnostic accuracy for sub-surface decay and improving treatment planning for patients.
Is the Spectra Fluorescence Caries Detection Device designed for single-use or reusable applications in a dental office?
The device is explicitly supplied as a reusable instrument, meaning it is intended for repeated use in dental settings after proper cleaning and maintenance. This design aligns with clinical workflows where durability and cost-effectiveness are priorities.
What regulatory pathway was followed for the Spectra Fluorescence Caries Detection Device, and what does this mean for its use?
The device was cleared through the FDA’s 510(k) pathway under Traditional Review (K090169), with a decision of Substantially Equivalent (SESE) to a predicate device. This means it meets FDA standards for Class II medical devices in dental diagnostics, ensuring compliance with safety and performance requirements for use in clinical settings.
Are there different models or sizes available for the Spectra Fluorescence Caries Detection Device?
The provided data lists multiple registration numbers (e.g., 3004884150, 3015729) under the product code NBL, which may correspond to variations or configurations of the device. However, specific details about distinct models or sizes (e.g., handpieces, probes, or software versions) are not explicitly described in the data. Contacting Air Techniques, Inc. would be necessary for precise model specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CamX Spectra Caries Detection Aid - Air Techniques, CamX Spectra Caries Detection Aid - Air Techniques, Air Techniques CamX® Spectra Caries Detection Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090169 | Class II | Active |
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Manufacturer
- Manufacturer
- Air Techniques, Inc.
Sources (1)
- FDA 510(k) K090169 24 fields · synced Sep 18, 2026