Miscellaneous devices · 21 CFR 872 Subpart G
Plaque Disclosing Agent
Intended to enhance visualization of the presence of plaque on tooth surfaces.
- Companies listing it
- 1914 makers
- Brands and models
- 21
- 510(k) clearances
- 10 in five years
- FDA name
- Plaque Disclosing Agent
510(k) clearances per year, 1976–2026
Companies that list QJC
19 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Prevest Denpro Limited | India | Maker | Oradox Reveal Caries Revealing Tabs | 7 | 2024 |
| Young Innovations Inc | United States | Maker | Disclosing Solution, Disclosing Tablets · Plak Duo Tone Disclosing Tablets | 23 | 2025 |
| Dental Technologies, Inc. | United States | Maker | — | 2 | 2013 |
| Directa AB | Sweden | Maker | Rondell | 1 | 2015 |
| Aadi Med Private Limited | India | Maker | PLAQUE-D | — | — |
| Svenska Dentorama AB | Sweden | Maker | Dentorama Disclosing Pellets | — | — |
| Anhui Greenland Biotech Co.,Ltd | China | Maker | Y-Kelin | — | — |
| Viarden Lab LLC | United States | Maker | DT DISCLOSING TABLET VIARDEN LAB, DT DISCLOSING SOLUTION VIARDEN LAB | — | — |
| Shenzhen Jie Bishi Technology Co., LTD | China | Maker | Dental plaque removal agent · T11,T11 Pro,T11 Pro+,T12 Pro,T10,T99,T100,T200,T300,T9,T10 Pro,T12 Plus,T13,T13 Pro,T12,T20,T15,T15pr0,T18,T18pr0,T19 · T19pr0,T22 | — | — |
| Omedic Technology (Dongguan) Co., Ltd | China | Maker | CH066,CH068,CH065,CH063,CH069,OMU01,OMU02,OMU03,OMU05,OMU06 · Ultrasonic tooth cleaner,Ultrasonic Calculus Remover,Dental Plaque Tool Teeth Cleaning Kit | — | — |
| Xingyue Medical Health Technology (Nanjing) Co., Ltd . | China | Maker | plaque indicator | — | — |
| Beutlich Pharmaceuticals, LLC | United States | Maker | HurriView ® Plaque Indicating Snap-n-Go Swabs · HurriView II ® Two-Tone Plaque Indicating Snap-n-Go Swabs | — | — |
| CaviSense, Inc | United States | Maker | CaviSense Toothpick · CaviSense Tray | — | — |
| Shandong Tongshun Medical Equipment Co., Ltd. | China | Maker | — | — | — |
| DSI Dental Solutions Ltd | Israel | Manufacturer | — | 2 | 2025 |
| Hager Worldwide, Inc. | United States | Manufacturer | Quick-Detect | 2 | 2005 |
| Esthetic Orthodontic Company of America LLC | United States | Repacker / relabeler | Divulge | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Oral Prevent USA Corporation | United States | Repacker / relabeler | Oral Prevent plaque disclosing tablets | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 20 Jun 1977 | K770990 | DENTAL PLAQUE DISCLOSING AGENT | Evident Dental Co. , Ltd. |
Official records: FDA product classification for QJC · 21 CFR 872.6855.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026