Data / Medical devices / Teeth, Artificial, Backing And Facing
Teeth, Artificial, Backing And Facing (ELK): 22 FDA-registered makers in 12 countries
22 establishments in 12 countries are registered with the FDA to make Teeth, Artificial, Backing And Facing (product code ELK, Class 1, 21 CFR 872.3910). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on July 15, 1981, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ELK
- Device class
- 1
- Regulation
- 872.3910
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 9 |
| South Korea | 2 |
| United States | 2 |
| Canada | 1 |
| United Arab Emirates | 1 |
| Vietnam | 1 |
| Germany | 1 |
| Mexico | 1 |
| Colombia | 1 |
| Taiwan | 1 |
| Netherlands | 1 |
| Pakistan | 1 |
Makers of Teeth, Artificial, Backing And Facing
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 |
|---|---|---|---|---|---|---|---|---|
| 5 Axis Dental Inc. | Whitby Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Clean Dental Instrument Technology Co.,ltd | Anqing City Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arak Dental Lab | Sharjah Dubayy, United Arab Emirates | 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 | |
| Dentona AG | Dortmund North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foo Tian Dental Laboratory | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Improve Co.,limited | Lantau Island Hong Kong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JINTAIK (Yunnan) BIOTECH CO., LTD. | Kunming Yunnan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linjiang (holdings) Limited | Shangqiu Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manufacturera Dental Continental | ZAPOPAN Jalisco, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maya Villegas S.A.S. | MEDELLIN Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minish Dental Lab Co.,ltd | Seoul, South Korea | 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 | |
| Opcom Inc. | New Taipei City, Taiwan | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Royal Dental Lab | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smart Dental Cad Solutions Limited | Zhuhai Guangdong, China | Exporter to the US, 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 | |
| The Belport Company, Inc DBA Gingi-Pak | Camarillo, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vertex-Dental B.V. | Soesterberg Utrecht, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiao Fei Dental Manufacture (Chengdu) Co.Ltd | CHENGDU Sichuan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xplora USA LLC | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zain's Medical Image | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 15, 1981. 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.