Data / Medical devices / Tip, Rubber, Oral Hygiene
Tip, Rubber, Oral Hygiene (JEW): 29 FDA-registered makers in 7 countries
29 establishments in 7 countries are registered with the FDA to make Tip, Rubber, Oral Hygiene (product code JEW, Class 1, 21 CFR 872.6650). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on September 25, 1986, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JEW
- Device class
- 1
- Regulation
- 872.6650
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 15 |
| United States | 7 |
| South Korea | 3 |
| Pakistan | 1 |
| Taiwan | 1 |
| Denmark | 1 |
| Mexico | 1 |
Makers of Tip, Rubber, Oral Hygiene
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 |
|---|---|---|---|---|---|---|---|---|
| Acme Enterprises | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B&L Biotech Co., Inc | Ansan City Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CDM Center Of Excellence Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Morristown, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Batavia, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DR. Tung's Products | Kaneohe, HI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enchant Tek Co. Ltd. | Dongshan Township, Yilan County Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ergodenta Aps | Taastrup Hovedstaden, Denmark | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Essentia Industries Ltd. | Dong Guan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guang Xi Fulaiming Biopharmaceutics Co., Ltd. | Nanning Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HT Co., Ltd. | Yongin-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua DK Dental Co., Ltd | HuangHua Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inter-Med, Inc. | Racine, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangmen Zhi Qu Metal Plastic Industrial Co., Ltd. | Jiangmen, Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Zhong Heng Pet Articles Joint-Stock Co.,ltd | Yancheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Partner Home Co., Ltd. | Nanchang City Jiangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinyuan Medical Equipment(tianjin)co.,ltd | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Aolbea Oral Care Products Co., Ltd | Yuyao City Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Procter & Gamble Manufacturing Mexico S. de R.L. de C.V. | Estado de Mexico, C.P., Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qibei Technology Co., Limited | KL Hong Kong, China | Exporter to the US, 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 | |
| Rosemarie Products Company, LLC | Mason, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seilglobal Co., Ltd | Busan Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Fumaite Oral Care Products Co. Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tess Oral Health LLC | Eau Claire, WI, United States | 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 | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 25, 1986. 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.