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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.

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Product code
EJH
Device class
2
Regulation
872.3710
Medical specialty
Dental

Makers by country

CountryMakers
China21
Germany16
United States10
Italy3
Hong Kong2
India2
Austria1
France1
Switzerland1
Liechtenstein1
Mexico1
Taiwan1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aalba Dent, Inc.Fairfield, CA, United StatesManufacturer13March 4, 2004000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer4February 15, 2001000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyManufacturer1December 16, 1991000api.fda.gov
Talladium, Inc.Santa Clarita, CA, United StatesManufacturer1December 20, 1989000api.fda.gov
The Argen CorporationSan Diego, CA, United StatesManufacturer, Repackager or relabeler1September 26, 2000000api.fda.gov
The Argen CorporationSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1September 26, 2000000api.fda.gov
Avimetal Am (xuzhou) Co., Ltd.Xuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Adentatec GmbHWoerth am Main Bavaria, GermanyManufacturer0000api.fda.gov
Amann Girrbach AGMaeder Vorarlberg, AustriaComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
Bego Bremer Goldschlaegerei Wilh. Herbst GMBH & Co. KGBremen, GermanyManufacturer0000api.fda.gov
Bernard Cervos Societe (B.C.S) S.A.SChassieu, Rhone Alpes Auvergne-Rhone-Alpes, FranceManufacturer, Specification developer0000api.fda.gov
Bredent GMBH & Co.kgSENDEN Bavaria, GermanyManufacturer0000api.fda.gov
Changshu Shangchi Dental Materials Co., Ltd.Changshu Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Crown Trading (HK) Co., LimitedHong Kong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Degudent GMBHHANAU Hesse, GermanyManufacturer0000api.fda.gov
Dfs-Diamon GMBHRIEDENBURG Bavaria, GermanyManufacturer0000api.fda.gov
Digital Dental Depotzhuhai Guangdong, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Digital Dental Depot LimitedHong Kong, Hong KongContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Eisenbacher Dentalwaren Ed GMBHWOERTH Bavaria, GermanyManufacturer0000api.fda.gov
Eastern Progress Plastic & Electronic Manufactory Co., Ltd.Dongguan, Guangdong, Hong KongContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Fseven Dental Technology Zhuhai Co.,ltdZHUHAI Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
GC America Inc.Alsip, IL, United StatesManufacturer0000api.fda.gov
Institut Straumann AGBASEL Basel-Stadt, SwitzerlandSpecification developer0000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinSpecification developer0000api.fda.gov
Ivoclar Vivadent, Inc.Amherst, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Ivoclar Vivadent Manufacturing GmbHNATURNO (BZ) Bolzano, ItalyContract manufacturer0000api.fda.gov
Jiangsu Vilory Advanced Materials Co., Ltd.Xuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Manufacturera Dental ContinentalZAPOPAN Jalisco, MexicoExporter to the US, Specification developer0000api.fda.gov
Mesa Italia S.R.L.TRAVAGLIATO Brescia, ItalyManufacturer0000api.fda.gov
Nanjing Chamlion Laser Technology Co., Ltd.Nanjing Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nantong Jinyuan Intelligence Manufacturing Technology Co., LtdNanTong Jiangsu, ChinaManufacturer0000api.fda.gov
Neodontics IncGlendale, CA, United StatesManufacturer0000api.fda.gov
Peshing New Metal (changzhou) Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Power Dental Studio Milling Pvt LtdNoida Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
Qinhuangdao Audental Metal Technology Co., Ltd.Qinhuangdao City Hebei, ChinaManufacturer0000api.fda.gov
Realloy E.K.Krefeld North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Riton 3D Technology Co., LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Scheftner GMBHMainz Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
Schuetz Dental GMBHROSBACH Hesse, GermanyManufacturer0000api.fda.gov
Shanghai Frontier Material Tech Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shen Fu Arts LabShen Zhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen HLD Dental&technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Times Dental LabShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanyManufacturer0000api.fda.gov
Smilden Biotechnology Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
Smile Dental Laboratory Company LimitedZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Sunrise Dental Laboratory, Ltd.Kowloon, Hong Kong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Jiahong Dental Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Shenzhen Sunmc Dental Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Straumann Manufacturing, Inc.Mansfield, TX, United StatesContract manufacturer0000api.fda.gov
Vivi Dental LaboratoryShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Vedia Solutions, Division of Laxmi Dental LimitedPalghar Maharashtra, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Whitepeaks Dental Solutions GMBHHamminkeln North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
World Lab U.S.A.Irvine, CA, United StatesManufacturer for export0000api.fda.gov
Xi'an Sinotitanium Metals Co.,ltdXi an Shaanxi, ChinaManufacturer0000api.fda.gov
Yeti Dentalprodukte GMBHEngen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Zirkonzahn SRLGais Bolzano, ItalyManufacturer0000api.fda.gov
etkon GMBHMarkkleeberg Saxony, GermanyManufacturer0000api.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.