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.
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- Product code
- EFT
- Device class
- 1
- Regulation
- 872.3520
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 36 |
| China | 34 |
| India | 2 |
| Canada | 2 |
| Liechtenstein | 1 |
| Netherlands | 1 |
| Australia | 1 |
| Austria | 1 |
| Mexico | 1 |
| Taiwan | 1 |
| South Korea | 1 |
| Brazil | 1 |
| Germany | 1 |
| Switzerland | 1 |
| Ireland | 1 |
| United Kingdom | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bonyf AG | Vaduz, Liechtenstein | Manufacturer | 1 | June 2, 2006 | 0 | 0 | 0 | api.fda.gov |
| Diamond Wipes International, Inc. | Chino, CA, United States | Contract manufacturer, Repackager or relabeler | 1 | May 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Accupac, LLC | Mainland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Akervall Technologies | Saline, MI, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Align Technology, Inc. | San Jose, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Andpak, Inc. | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui GREENLAND BIOTECH CO.,LTD | Bengbu Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Berrygood Products LLC | Lake Mary, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cavex Holland B.V. | HAARLEM Noord-Holland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Freshday Household Products Corp. Ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cory Labs | Alsip, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | York, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Doc Brands, Inc. | Knoxville, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Sirona Orthodontics Inc. | Sarasota, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ekong Technology Co., Limited. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erskine Dental | MACKSVILLE New South Wales, Australia | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EverBrands, Inc. | Garden Grove, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fittydent Intl. GMBH | Vienna Wien, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Ousidun Personal Care Products Co.,ltd | FOSHAN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fuzhou Delphin Bio-Tech Co., Ltd. | Fuzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Goran Pharma Pvt. Ltd. | Sihor Gujarat, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gurunanda LLC | Buena Park, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Xinuo Personal Care Products Co., Ltd | Yunfu City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Namei Zhikang Technology Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Havpak, Inc. | Malvern, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Kangcheng Non-Woven Co., Ltd | XIANTAO Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haleon US HOLDINGS LLC | Warren, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haleon US Holdings LLC | East Durham, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haleon US Inc. | Lincoln, NE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isonic Inc. | Chicago, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Dentalbright Technology Co., Ltd | Jiujiang City Jiangxi, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Ivismile Technology Co.,ltd | Yichun City Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiaoyue Pharmaceutical (huizhou) Co.ltd | Huizhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Ushine Bright Medical Co., Ltd. | Jiujiang City Jiangxi, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kingkey MBC Life Technology Group Co.,ltd. | Shantou Guangdong, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KP Dental LLC | Wilmington, DE, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kulzer, LLC | South Bend, IN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LLRN Personal Care (shenzhen) Co.,ltd | shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lma Solutions Inc. | Raleigh, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LMZ | yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manufacturera Dental Continental | ZAPOPAN Jalisco, Mexico | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech Products, Inc. | Tarrytown, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mid-Continental Dental Supply Co., Ltd. | Winnipeg Manitoba, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Movemints, LLC | Pittsburgh, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MicroCare Medical | Commerce City, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanchang White Technology Co., Ltd. | Nanchang Jiangxi, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New World Imports, Inc. | Nashville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Favored Commodity Co.,ltd | NINGBO Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Eos Industries, Inc. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novalab Inc. | DRUMMONDVILLE Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Day Dental Partner | Suncheon-si Jeonnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orvance, LLC | Caledonia, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PHS Do Brasil Ltda | Joinville Santa Catarina, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasdent Shanghai Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prevest Denpro Limited | Jammu Jammu and Kashmir, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Procter & Gamble Co., Regulatory Affairs | Mason, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PROCTER & GAMBLE MANUFACTURING GmbH | GROSS-GERAU Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Produits Dentaires SA | VEVEY (SUISSE) Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protech Professional Products, Inc. | Boynton Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Redi-2-Paq Home Products, LLC | Sarasota, FL, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Regent Labs, Inc. | Deerfield Bch, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Balinda Technology Co.,ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Moye Technology Co Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sheffield Pharmaceuticals LLC | New London, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Senlede Technologies Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stafford-Miller Limited | DUNGARVAN Waterford(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermoplastic Comfort Systems, Inc. | Signal Hill, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Water Source Tech Co., Ltd. | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tower Laboratories, Ltd. | Centerbrook, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tower Laboratories Ltd | Clinton, CT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Huihai Commodity Manufacture Co., Ltd. | Weihai Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Jieshi Commodity Manufacture Co. Ltd. | Weihai,Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wisdom Toothbrushes Ltd. | HAVERHILL Suffolk, United Kingdom | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xingyue Medical Health Technology (nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yancheng Trancom First Aid Supplies Industrial Co., Ltd | Yangcheng Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Sinje Biotechnology Co.,ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Star Oral Care Product Co., Ltd. | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou Henan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.