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Data / Medical devices / Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium (KOT): 9 FDA-registered makers in 4 countries

9 establishments in 4 countries are registered with the FDA to make Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium (product code KOT, Class 1, 21 CFR 872.3490). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on December 20, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KOT
Device class
1
Regulation
872.3490
Medical specialty
Dental

Makers by country

CountryMakers
China6
Liechtenstein1
India1
Mexico1

Makers of Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

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
Anhui GREENLAND BIOTECH CO.,LTDBengbu Anhui, ChinaManufacturer0000api.fda.gov
Bonyf AGVaduz, LiechtensteinManufacturer0000api.fda.gov
Blossom PharmaceuticalsMapusa Goa, IndiaManufacturer0000api.fda.gov
Guangdong Xinuo Personal Care Products Co., LtdYunfu City Guangdong, ChinaManufacturer0000api.fda.gov
Jiangxi Ushine Bright Medical Co., Ltd.Jiujiang City Jiangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
LLRN Personal Care (shenzhen) Co.,ltdshenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Manufacturera Dental ContinentalZAPOPAN Jalisco, MexicoManufacturer0000api.fda.gov
Nanchang White Technology Co., Ltd.Nanchang Jiangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Senlede Technologies Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated December 20, 1994. 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.