Jedmed
Endoragard Teeth Protector DBL-Side
11manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Fujian (2), Hebei (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Fuzhou Delphin BIO-Tech Co., Ltd. | Fuzhou | Fujian | Manufacturer | 18 |
| Qibei Technology Co., Limited | Kl | Hong Kong | Manufacturer | 15 |
| Shenzhen Moye Technology Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 14 |
| Yuyao Rongda Plastic Industry Co., Ltd. | Yuyao | Zhejiang | Manufacturer | 9 |
| Dongguan Hengrui Silicone Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 3 |
| Shenzhen Xinjianli Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 1 |
Record
| Listed by | Jedmed Instrument Company, United States |
|---|---|
| FDA product code | BRW |
| Device type | Protector, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5820 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42-8185-3 | In distribution | |
| 42-8185-0 | In distribution | |
| 42-8185-2 | In distribution | |
| 42-8182 | In distribution | |
| 42-8185-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 9 |
| Henry Schein | Henry Schein, Inc. | 6 |
| Safco Mouth Props | Safco Dental Supply | 6 |
| RMO | RMO | 6 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 6 |
| KöR | Evolve Dental Technologies, Inc. | 5 |
| Plasdent | Plasdent Corp. | 4 |
| YC3 Shield | American Orthodontics | 4 |
| Teeth protector, metal | Spiggle & Theis Medizintechnik Gmbh | 4 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 3 |
| Palmero Healthcare, LLC | Palmero Healthcare LLC | 3 |
| Osung MND | Osung MND Co., Ltd. | 3 |
Showing 12 of 46. All products under Protector, Dental
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.