Data / Medical devices / Plaque Disclosing Kit
Plaque Disclosing Kit (NYH): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Plaque Disclosing Kit (product code NYH, Class 2, 21 CFR 872.1740). 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 December 4, 1978, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NYH
- Device class
- 2
- Regulation
- 872.1740
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| United States | 2 |
| Japan | 2 |
| France | 2 |
| Brazil | 1 |
| Mexico | 1 |
Makers of Plaque Disclosing Kit
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 |
|---|---|---|---|---|---|---|---|---|
| Angelus Industria De Productos Odontologicos | LONDRINA Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GUILIN YIKESHI Medical Device CO LTD | Guilin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Stars Pulse Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nimi Chemical Industrial Co., Ltd. | Kiryu Gunma, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nomax, Inc. | Affton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Satelec-Acteon Group | MERIGNAC Gironde, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sopro | LA CIOTAT CEDEX Bouches-du-Rhone, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou Henan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 4, 1978. 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.