Detector, Ultraviolet
The Ultraviolet Detector is a dental device used to detect caries, plaque, calculus, or restorative materials on tooth surfaces by illuminating them with ultraviolet light and observing fluorescence differences. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EAQ and the applicable regulation is 21 CFR 872.6350, under the Dental medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- EAQ
- Device Class
- FDA class 2
- Regulation Number
- 872.6350
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.