Skip to the page

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.

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
BRW
Device class
1
Regulation
868.5820
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States22
China11
South Korea4
Pakistan3
Sweden2
Australia2
Turkey1
Brazil1
Canada1
Malaysia1
Denmark1
Mexico1
Taiwan1
Hong Kong1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3bfab Teknoloji Anonim SirketiIstanbul, TurkeyManufacturer0000api.fda.gov
Akervall TechnologiesSaline, MI, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Angelus Industria De Productos OdontologicosLONDRINA Parana, BrazilManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesContract manufacturer0000api.fda.gov
Anesthesia Associates, Inc.San Marcos, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Buffalo Dental Mfg Co IncHancock, NY, United StatesManufacturer, Repackager or relabeler0000api.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
Directa ABUPPLANDS VAESBY Stockholm, SwedenManufacturer0000api.fda.gov
Dongguan Hengrui Silicone Products Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
DXM Co., Ltd.Jeonnam-Gwangju Special Metropolitan City, South KoreaManufacturer0000api.fda.gov
Ellapack Pty LtdKeysborough Victoria, AustraliaContract manufacturer0000api.fda.gov
Fuzhou Delphin Bio-Tech Co., Ltd.Fuzhou Fujian, ChinaManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Gestenco International ABGOTEBORG Vastra Gotaland, SwedenManufacturer0000api.fda.gov
Graphy Inc.Seoul, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesManufacturer0000api.fda.gov
Hdi Inc.Seongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Innovgas Pty LtdDocklands Victoria, AustraliaManufacturer0000api.fda.gov
IPE Plastic & Hardware Industy, LTDDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Jefferson Rubber WorksWorcester, MA, United StatesContract manufacturer0000api.fda.gov
JMS Manufacturing, Inc.Omaha, NE, United StatesContract manufacturer0000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Merryweather Foam, Inc.Barberton, OH, United StatesContract manufacturer0000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer0000api.fda.gov
Nasorcap Medical, Inc.Venetia, PA, United StatesManufacturer0000api.fda.gov
Oculo Plastik, Inc.MONTREAL Quebec, CanadaManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Plaxtron Industrial (M) Sdn. Bhd.IPOH Perak, MalaysiaContract manufacturer0000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Qibei Technology Co., LimitedKL Hong Kong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ronvig Dental MFG. A/SDAUGAARD Midtjylland, DenmarkManufacturer0000api.fda.gov
Sage Products LLCCary, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Salmon Medical Innovations, LLCChestertown, MD, United StatesManufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Shengiho Enterprise Co., Ltd.Taichung City, TaiwanManufacturer0000api.fda.gov
Shenzhen Moye Technology Co LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Xinjianli Technology Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
SKY DENT Corp for dental tradingNew York, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Sweetguard IncCity of Industry, CA, United StatesManufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer0000api.fda.gov
Suzhou Meccan Import and Export Corp.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Viarden Lab LLCMission, TX, United StatesManufacturer0000api.fda.gov
World Dentists Association America LimitedTsim Sha, Hong KongManufacturer0000api.fda.gov
Xiamen Yizhou Imp. & Exp. Co., Ltd.Xiamen Fujian, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Yuyao Rongda Plastic Industry Co., Ltd.Yuyao Zhejiang, ChinaManufacturer0000api.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.