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Data / Medical devices / Cleanser, Denture, Over The Counter

Cleanser, Denture, Over The Counter (EFT): 86 FDA-registered makers in 16 countries

86 establishments in 16 countries are registered with the FDA to make Cleanser, Denture, Over The Counter (product code EFT, Class 1, 21 CFR 872.3520). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on May 23, 2008, and lists 2 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
EFT
Device class
1
Regulation
872.3520
Medical specialty
Dental

Makers by country

CountryMakers
United States36
China34
India2
Canada2
Liechtenstein1
Netherlands1
Australia1
Austria1
Mexico1
Taiwan1
South Korea1
Brazil1
Germany1
Switzerland1
Ireland1
United Kingdom1

Makers of Cleanser, Denture, Over The Counter

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
Bonyf AGVaduz, LiechtensteinManufacturer1June 2, 2006000api.fda.gov
Diamond Wipes International, Inc.Chino, CA, United StatesContract manufacturer, Repackager or relabeler1May 23, 2008000api.fda.gov
Accupac, LLCMainland, PA, United StatesContract manufacturer0000api.fda.gov
Akervall TechnologiesSaline, MI, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Align Technology, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Andpak, Inc.Morgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Anhui GREENLAND BIOTECH CO.,LTDBengbu Anhui, ChinaManufacturer0000api.fda.gov
Berrygood Products LLCLake Mary, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Cavex Holland B.V.HAARLEM Noord-Holland, NetherlandsManufacturer0000api.fda.gov
Changzhou Freshday Household Products Corp. Ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Cory LabsAlsip, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Changzhou IVORIE Shengmei Packaging Technology Co.LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer0000api.fda.gov
Doc Brands, Inc.Knoxville, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ekong Technology Co., Limited.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Erskine DentalMACKSVILLE New South Wales, AustraliaExporter to the US, Specification developer0000api.fda.gov
EverBrands, Inc.Garden Grove, CA, United StatesManufacturer0000api.fda.gov
Fittydent Intl. GMBHVienna Wien, AustriaManufacturer0000api.fda.gov
Foshan Ousidun Personal Care Products Co.,ltdFOSHAN Guangdong, ChinaManufacturer0000api.fda.gov
Fuzhou Delphin Bio-Tech Co., Ltd.Fuzhou Fujian, ChinaManufacturer0000api.fda.gov
Goran Pharma Pvt. Ltd.Sihor Gujarat, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Gurunanda LLCBuena Park, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesSpecification developer0000api.fda.gov
Guangdong Xinuo Personal Care Products Co., LtdYunfu City Guangdong, ChinaManufacturer0000api.fda.gov
Hangzhou Namei Zhikang Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Havpak, Inc.Malvern, PA, United StatesContract manufacturer0000api.fda.gov
Hubei Kangcheng Non-Woven Co., LtdXIANTAO Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Haleon US HOLDINGS LLCWarren, NJ, United StatesSpecification developer0000api.fda.gov
Haleon US Holdings LLCEast Durham, NY, United StatesManufacturer0000api.fda.gov
Haleon US Inc.Lincoln, NE, United StatesManufacturer0000api.fda.gov
Isonic Inc.Chicago, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Jiangxi Dentalbright Technology Co., LtdJiujiang City Jiangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangxi Ivismile Technology Co.,ltdYichun City Jiangxi, ChinaManufacturer0000api.fda.gov
Jiaoyue Pharmaceutical (huizhou) Co.ltdHuizhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangxi Ushine Bright Medical Co., Ltd.Jiujiang City Jiangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kingkey MBC Life Technology Group Co.,ltd.Shantou Guangdong, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
KP Dental LLCWilmington, DE, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Kulzer, LLCSouth Bend, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
LLRN Personal Care (shenzhen) Co.,ltdshenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Lma Solutions Inc.Raleigh, NC, United StatesSpecification developer0000api.fda.gov
LMZyangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Manufacturera Dental ContinentalZAPOPAN Jalisco, MexicoSpecification developer0000api.fda.gov
Medtech Products, Inc.Tarrytown, NY, United StatesSpecification developer0000api.fda.gov
Mid-Continental Dental Supply Co., Ltd.Winnipeg Manitoba, CanadaManufacturer0000api.fda.gov
Movemints, LLCPittsburgh, PA, United StatesSpecification developer0000api.fda.gov
MicroCare MedicalCommerce City, CO, United StatesManufacturer0000api.fda.gov
Nanchang White Technology Co., Ltd.Nanchang Jiangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
New World Imports, Inc.Nashville, TN, United StatesSpecification developer0000api.fda.gov
Ningbo Favored Commodity Co.,ltdNINGBO Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
North Eos Industries, Inc.Taichung City, TaiwanManufacturer0000api.fda.gov
Novalab Inc.DRUMMONDVILLE Quebec, CanadaContract manufacturer0000api.fda.gov
One Day Dental PartnerSuncheon-si Jeonnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Orvance, LLCCaledonia, MI, United StatesSpecification developer0000api.fda.gov
PHS Do Brasil LtdaJoinville Santa Catarina, BrazilManufacturer0000api.fda.gov
Plasdent Shanghai Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Prevest Denpro LimitedJammu Jammu and Kashmir, IndiaManufacturer0000api.fda.gov
Procter & Gamble Co., Regulatory AffairsMason, OH, United StatesSpecification developer0000api.fda.gov
PROCTER & GAMBLE MANUFACTURING GmbHGROSS-GERAU Hesse, GermanyManufacturer0000api.fda.gov
Produits Dentaires SAVEVEY (SUISSE) Vaud, SwitzerlandManufacturer0000api.fda.gov
Protech Professional Products, Inc.Boynton Beach, FL, United StatesManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Redi-2-Paq Home Products, LLCSarasota, FL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
Regent Labs, Inc.Deerfield Bch, FL, United StatesManufacturer0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Balinda Technology Co.,ltdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Moye Technology Co LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Sheffield Pharmaceuticals LLCNew London, CT, United StatesContract manufacturer0000api.fda.gov
Shenzhen Senlede Technologies Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Stafford-Miller LimitedDUNGARVAN Waterford(County), IrelandManufacturer0000api.fda.gov
Thermoplastic Comfort Systems, Inc.Signal Hill, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Tianjin Water Source Tech Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
Tower Laboratories, Ltd.Centerbrook, CT, United StatesManufacturer0000api.fda.gov
Tower Laboratories LtdClinton, CT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Weihai Huihai Commodity Manufacture Co., Ltd.Weihai Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Weihai Jieshi Commodity Manufacture Co. Ltd.Weihai,Shandong, ChinaManufacturer0000api.fda.gov
Wisdom Toothbrushes Ltd.HAVERHILL Suffolk, United KingdomExporter to the US, Specification developer0000api.fda.gov
Xingyue Medical Health Technology (nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Yancheng Trancom First Aid Supplies Industrial Co., LtdYangcheng Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Yangzhou Sinje Biotechnology Co.,ltdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Star Oral Care Product Co., Ltd.Yangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhengzhou Huaer Electro-Optics Technology Co., Ltd.Zhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov

Updated May 23, 2008. 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.