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Data / Medical devices / Teeth, Artificial, Posterior With Metal Insert

Teeth, Artificial, Posterior With Metal Insert (ELJ): 32 FDA-registered makers in 7 countries

32 establishments in 7 countries are registered with the FDA to make Teeth, Artificial, Posterior With Metal Insert (product code ELJ, Class 1, 21 CFR 872.3900). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
ELJ
Device class
1
Regulation
872.3900
Medical specialty
Dental

Makers by country

CountryMakers
China15
South Korea7
United States4
Canada2
Vietnam2
United Arab Emirates1
Netherlands1

Makers of Teeth, Artificial, Posterior With Metal Insert

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
Arak Dental LabSharjah Dubayy, United Arab EmiratesManufacturer0000api.fda.gov
Aurum Ceramic Dental Laboratories LLCSpokane, WA, United StatesManufacturer0000api.fda.gov
Aurum Ceramic Dental Laboratories Ltd.CALGARY Alberta, CanadaManufacturer0000api.fda.gov
Classic Dental Laboratories Ltd.OTTAWA Ontario, CanadaManufacturer0000api.fda.gov
Cometech VN Company LimitedPhu Thanh Ward Ho Chi Minh, VietnamContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Crown MakersSeoul, South KoreaManufacturer0000api.fda.gov
DIO CorporationHaeundae-gu Busan, South KoreaManufacturer0000api.fda.gov
Hangzhou Thales Medtech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Huile Denture Technology(hongkong)co,limitedHONG KONG Hong Kong, ChinaContract sterilizer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Improve Co.,limitedLantau Island Hong Kong, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Innovaid Co.Seoul, South KoreaManufacturer0000api.fda.gov
Integrity Dental Services LLCDuluth, GA, United StatesManufacturer0000api.fda.gov
Istar Dental LabShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Joydenta Dental LaboratoryShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Nam A Dental Medicine Company LimitedThong Tay Hoi Ward Ho Chi Minh, VietnamManufacturer0000api.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
Perfect Crown Dental LabMaspeth, NY, United StatesManufacturer0000api.fda.gov
Ray Co., LtdYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Rite Smile LabsShenzhenzs Inner Mongolia, ChinaManufacturer0000api.fda.gov
Shenzhen HLD Dental&technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Times Dental LabShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
SMD Dental LaboratoryHeungdeok-gu Cheongju-si Chungbuk, South KoreaManufacturer0000api.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
Sunstar Trading International LimitedKowloon Hong Kong, ChinaManufacturer0000api.fda.gov
Shanghai dental labs INC.Shanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Vericom Co., Ltd.Chuncheon-Si Gangwon, South KoreaManufacturer0000api.fda.gov
Vertex-Dental B.V.Soesterberg Utrecht, NetherlandsManufacturer0000api.fda.gov
Wellstone Dental LLCBuena Park, CA, United StatesManufacturer0000api.fda.gov
Xiao Fei Dental Manufacture (Chengdu) Co.LtdCHENGDU Sichuan, ChinaManufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov

Updated November 2, 2026. 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.