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Data / Medical devices / Denture Preformed (Partially Prefabricated Denture)

Denture Preformed (Partially Prefabricated Denture) (EKO): 19 FDA-registered makers in 8 countries

19 establishments in 8 countries are registered with the FDA to make Denture Preformed (Partially Prefabricated Denture) (product code EKO, Class 2, 21 CFR 872.3600). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on December 5, 1990, 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.

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Product code
EKO
Device class
2
Regulation
872.3600
Medical specialty
Dental

Makers by country

CountryMakers
China7
United States5
Germany2
India1
Dominican Republic1
Mexico1
South Korea1
Italy1

Makers of Denture Preformed (Partially Prefabricated 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Xiao Fei Dental Manufacture (Chengdu) Co.LtdCHENGDU Sichuan, ChinaManufacturer1October 15, 1976000api.fda.gov
Aadi Med Private LimitedDist. Palghar Maharashtra, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Bredent GMBH & Co.kgSENDEN Bavaria, GermanyManufacturer0000api.fda.gov
Caribbean Custom Mold IncSanto Domingo, Dominican RepublicContract manufacturer, Repackager or relabeler0000api.fda.gov
Clemde S.A. De C.V.MEXICO, DF Ciudad de Mexico, MexicoManufacturer0000api.fda.gov
Foo Tian Dental LaboratoryShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
George Taub Products & Fusion Co., Inc.Jersey City, NJ, United StatesManufacturer0000api.fda.gov
Guangzhou Jinguanqiao Industry Co., LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Integrity Dental Services LLCDuluth, GA, United StatesManufacturer0000api.fda.gov
Kelsey Dental LLCThe Woodlands, TX, United StatesSpecification developer0000api.fda.gov
Mabel Dental LabCuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
Merz Dental GMBHLUETJENBURG Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Nanjing Chamlion Laser Technology Co., Ltd.Nanjing Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
One Day Dental PartnerSuncheon-si Jeonnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Qinhuangdao Audental Metal Technology Co., Ltd.Qinhuangdao City Hebei, ChinaManufacturer0000api.fda.gov
Shenzhen Jiahong Dental Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Sonrisa/Easy Denture/NSIWilmington, NC, United StatesSpecification developer0000api.fda.gov
Xi'an Sinotitanium Metals Co.,ltdXi an Shaanxi, ChinaManufacturer0000api.fda.gov
Zirkonzahn SRLGais Bolzano, ItalyManufacturer0000api.fda.gov

Updated December 5, 1990. 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.