Miscellaneous devices · 21 CFR 872 Subpart G
Ultraviolet Detector
FDA device type “Detector, Ultraviolet”.
- Companies listing it
- 44 makers
- Brands and models
- 24
- 510(k) clearances
- 20 in five years
- FDA name
- Detector, Ultraviolet
510(k) clearances per year, 1976–2026
Companies that list EAQ
4 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Ultradent Products, Inc. | United States | Maker | VALO Black Light Lens, VALO Grand Black Light Lens · VALO Grand White Light Lens · VALO Interproximal Lens, VALO Grand Interproximal Lens · VALO PointCure Lens, VALO Grand PointCure Lens · +14 | 95 | 2026 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | LED Curing Lights; DB686 HALO | 6 | 2025 |
| GreenMark Biomedical Inc. | United States | Maker | LumiCare | 2 | 2025 |
| Dentlight, Inc. | United States | Maker | Dentlight Oral Exam Light Kit · DOE · DOE SE · FUSION-DOE | 3 | 2019 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 28 Jul 1994 | K934728 | SUNSOR ULTRAVIOLET METER | Sunsor, Inc. |
| 26 Apr 1977 | K770685 | LIGHT, EXAMINING, DENTAL, ULTRA VIOLET | Parker Laboratories, Inc. |
Official records: FDA product classification for EAQ · 21 CFR 872.6350.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026