Data / Medical devices / Protector, Dental
Protector, Dental (BRW): 52 FDA-registered makers in 14 countries
52 establishments in 14 countries are registered with the FDA to make Protector, Dental (product code BRW, Class 1, 21 CFR 868.5820). 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 December 7, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BRW
- Device class
- 1
- Regulation
- 868.5820
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 22 |
| China | 11 |
| South Korea | 4 |
| Pakistan | 3 |
| Sweden | 2 |
| Australia | 2 |
| Turkey | 1 |
| Brazil | 1 |
| Canada | 1 |
| Malaysia | 1 |
| Denmark | 1 |
| Mexico | 1 |
| Taiwan | 1 |
| Hong Kong | 1 |
Makers of Protector, Dental
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 |
|---|---|---|---|---|---|---|---|---|
| 3bfab Teknoloji Anonim Sirketi | Istanbul, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Akervall Technologies | Saline, MI, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angelus Industria De Productos Odontologicos | LONDRINA Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Buffalo Dental Mfg Co Inc | Hancock, NY, United States | Manufacturer, Repackager or relabeler | 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 | |
| Directa AB | UPPLANDS VAESBY Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Hengrui Silicone Products Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DXM Co., Ltd. | Jeonnam-Gwangju Special Metropolitan City, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ellapack Pty Ltd | Keysborough Victoria, Australia | Contract 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 | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gestenco International AB | GOTEBORG Vastra Gotaland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Graphy Inc. | Seoul, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hdi Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Guarddent Medical Technology Co.,ltd | Wuhan Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovgas Pty Ltd | Docklands Victoria, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IPE Plastic & Hardware Industy, LTD | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jefferson Rubber Works | Worcester, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JMS Manufacturing, Inc. | Omaha, NE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merryweather Foam, Inc. | Barberton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nasorcap Medical, Inc. | Venetia, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculo Plastik, Inc. | MONTREAL Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plaxtron Industrial (M) Sdn. Bhd. | IPOH Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Practicon, Inc. | Greenville, NC, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prime Dental Manufacturing, Inc. | Chicago, IL, United States | 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 | |
| Ronvig Dental MFG. A/S | DAUGAARD Midtjylland, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sage Products LLC | Cary, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Salmon Medical Innovations, LLC | Chestertown, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shengiho Enterprise Co., Ltd. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Moye Technology Co Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Xinjianli Technology Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SKY DENT Corp for dental trading | New York, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicrafts | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sweetguard Inc | City of Industry, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Meccan Import and Export Corp. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viarden Lab LLC | Mission, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| World Dentists Association America Limited | Tsim Sha, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Yizhou Imp. & Exp. Co., Ltd. | Xiamen Fujian, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yuyao Rongda Plastic Industry Co., Ltd. | Yuyao Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 7, 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.