Diagnostic devices · 21 CFR 872 Subpart B
Plaque Disclosing Kit
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Companies listing it
- 118 makers
- Brands and models
- 13
- 510(k) clearances
- 10 in five years
- FDA name
- Plaque Disclosing Kit
510(k) clearances per year, 1976–2026
Companies that list NYH
11 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| GC America Inc. | United States | Maker | GC Tri Plaque ID Gel | 137 | 2026 |
| Satelec - Acteon Group | United States | Maker | FLAG FOR B.LED SATELEC FLAG FOR B.LED · Mini Dock U USB2 · Mini Dock USB2 | 18 | 2024 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | DISCLOSING AGENT | 11 | 2021 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | Dental Plaque Indicator | 1 | 2020 |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | Plaque Indicator | — | — |
| Guangzhou Stars Pulse Co.,Ltd. | China | Maker | D-lite OralCam, Models: USM057 · usmile, D50 OralCam Electric Toothbrush, MOD: USM551, USM521 | — | — |
| Nomax Inc. | United States | Maker | — | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| DCI International LLC | United States | Manufacturer | Kit, Mini Dock U-USB2, w/o Camera, Acteon, Light Gray · Kit, Mini Dock U-USB2, w/o Camera, Acteon, Series 5, Light Gray · Kit, Mini Dock U-USB2, w/o Camera, Acteon, White · Mini Dock U-USB2, Light Gray, Intra-Oral Camera, Acteon | 1 | 2025 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 4 Dec 1978 | K781919 | PLAQUE DETECTION SYSTEM | Clairol, Inc. |
Official records: FDA product classification for NYH · 21 CFR 872.1740.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026