Data / Medical devices / Coating, Denture Hydrophilic, Resin
Coating, Denture Hydrophilic, Resin (EBE): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Coating, Denture Hydrophilic, Resin (product code EBE, Class 2, 21 CFR 872.3300). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on October 27, 1983, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EBE
- Device class
- 2
- Regulation
- 872.3300
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| Brazil | 1 |
| South Korea | 1 |
| China | 1 |
Makers of Coating, Denture Hydrophilic, Resin
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 |
|---|---|---|---|---|---|---|---|---|
| Evoden Industria Comercio Importacao E Exportacao De Produtos Odontologicos Ltda. | Pirassununga Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Day Dental Partner | Suncheon-si Jeonnam, South Korea | Exporter to the US, 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 October 27, 1983. 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.