Data / Medical devices / Teeth, Preformed Gold Denture
Teeth, Preformed Gold Denture (ELN): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Teeth, Preformed Gold Denture (product code ELN, Class 1, 21 CFR 872.3580). 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 1, 1977, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ELN
- Device class
- 1
- Regulation
- 872.3580
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| Vietnam | 1 |
| Hong Kong | 1 |
Makers of Teeth, Preformed Gold Denture
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 |
|---|---|---|---|---|---|---|---|---|
| Beijing Yingguan Dental Science&technology Co.,ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cometech VN Company Limited | Phu Thanh Ward Ho Chi Minh, Vietnam | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fseven Dental Technology Zhuhai Co.,ltd | ZHUHAI Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sky HKMC International Limited | Hong Kong, Hong Kong | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smile Dental Laboratory Company Limited | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai dental labs INC. | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 1, 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.