Data / Medical devices / Plaque Disclosing Agent
Plaque Disclosing Agent (QJC): 14 FDA-registered makers in 4 countries
14 establishments in 4 countries are registered with the FDA to make Plaque Disclosing Agent (product code QJC, Class 1, 21 CFR 872.6855). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on June 20, 1977, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QJC
- Device class
- 1
- Regulation
- 872.6855
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| United States | 5 |
| India | 2 |
| Sweden | 2 |
Makers of Plaque Disclosing Agent
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aadi Med Private Limited | Dist. Palghar Maharashtra, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui GREENLAND BIOTECH CO.,LTD | Bengbu Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beutlich Pharmaceuticals, LLC | Bunnell, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cavisense, Inc | Allston, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Technologies, Inc. | Lincolnwood, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Directa AB | UPPLANDS VAESBY Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omedic Technology (dongguan) Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prevest Denpro Limited | Jammu Jammu and Kashmir, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Tongshun Medical Equipment Co., Ltd. | Weifang City Shandong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jie Bishi Technology Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Svenska Dentorama AB | SOLLENTUNA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viarden Lab LLC | Mission, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xingyue Medical Health Technology (nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Dental Manufacturing Co 1, LLC. | Earth City, MO, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 20, 1977. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.