Data / Medical devices / Alloy, Metal, Base
Alloy, Metal, Base (EJH): 60 FDA-registered makers in 12 countries
60 establishments in 12 countries are registered with the FDA to make Alloy, Metal, Base (product code EJH, Class 2, 21 CFR 872.3710). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 153 510(k) clearances under this code, the latest on March 14, 2013, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- EJH
- Device class
- 2
- Regulation
- 872.3710
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 21 |
| Germany | 16 |
| United States | 10 |
| Italy | 3 |
| Hong Kong | 2 |
| India | 2 |
| Austria | 1 |
| France | 1 |
| Switzerland | 1 |
| Liechtenstein | 1 |
| Mexico | 1 |
| Taiwan | 1 |
Makers of Alloy, Metal, Base
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 |
|---|---|---|---|---|---|---|---|---|
| Aalba Dent, Inc. | Fairfield, CA, United States | Manufacturer | 13 | March 4, 2004 | 0 | 0 | 0 | api.fda.gov |
| The Belport Company, Inc DBA Gingi-Pak | Camarillo, CA, United States | Manufacturer | 4 | February 15, 2001 | 0 | 0 | 0 | api.fda.gov |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer | 1 | December 16, 1991 | 0 | 0 | 0 | api.fda.gov |
| Talladium, Inc. | Santa Clarita, CA, United States | Manufacturer | 1 | December 20, 1989 | 0 | 0 | 0 | api.fda.gov |
| The Argen Corporation | San Diego, CA, United States | Manufacturer, Repackager or relabeler | 1 | September 26, 2000 | 0 | 0 | 0 | api.fda.gov |
| The Argen Corporation | San Diego, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | September 26, 2000 | 0 | 0 | 0 | api.fda.gov |
| Avimetal Am (xuzhou) Co., Ltd. | Xuzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Adentatec GmbH | Woerth am Main Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amann Girrbach AG | Maeder Vorarlberg, Austria | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bego Bremer Goldschlaegerei Wilh. Herbst GMBH & Co. KG | Bremen, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bernard Cervos Societe (B.C.S) S.A.S | Chassieu, Rhone Alpes Auvergne-Rhone-Alpes, France | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bredent GMBH & Co.kg | SENDEN Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changshu Shangchi Dental Materials Co., Ltd. | Changshu Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crown Trading (HK) Co., Limited | Hong Kong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Degudent GMBH | HANAU Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dfs-Diamon GMBH | RIEDENBURG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot | zhuhai Guangdong, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot Limited | Hong Kong, Hong Kong | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eisenbacher Dentalwaren Ed GMBH | WOERTH Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eastern Progress Plastic & Electronic Manufactory Co., Ltd. | Dongguan, Guangdong, Hong Kong | Contract manufacturer, Manufacturer, 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 | |
| GC America Inc. | Alsip, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent, Inc. | Amherst, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing GmbH | NATURNO (BZ) Bolzano, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Vilory Advanced Materials Co., Ltd. | Xuzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manufacturera Dental Continental | ZAPOPAN Jalisco, Mexico | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mesa Italia S.R.L. | TRAVAGLIATO Brescia, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Chamlion Laser Technology Co., Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nantong Jinyuan Intelligence Manufacturing Technology Co., Ltd | NanTong Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neodontics Inc | Glendale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peshing New Metal (changzhou) Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Power Dental Studio Milling Pvt Ltd | Noida Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puracon GMBH | Rosenheim Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao City Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Realloy E.K. | Krefeld North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riton 3D Technology Co., Ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scheftner GMBH | Mainz Rhineland-Palatinate, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schuetz Dental GMBH | ROSBACH Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Frontier Material Tech Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shen Fu Arts Lab | Shen Zhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen HLD Dental&technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Times Dental Lab | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smilden Biotechnology Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smile Dental Laboratory Company Limited | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunrise Dental Laboratory, Ltd. | Kowloon, Hong Kong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jiahong Dental Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straumann Manufacturing, Inc. | Mansfield, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vivi Dental Laboratory | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vedia Solutions, Division of Laxmi Dental Limited | Palghar Maharashtra, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Whitepeaks Dental Solutions GMBH | Hamminkeln North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| World Lab U.S.A. | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xi'an Sinotitanium Metals Co.,ltd | Xi an Shaanxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yeti Dentalprodukte GMBH | Engen Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zirkonzahn SRL | Gais Bolzano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| etkon GMBH | Markkleeberg Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 14, 2013. 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.