Henry Schein
Band Biter
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Hebei (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Qibei Technology Co., Limited | Kl | Hong Kong | Manufacturer | 15 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Hangzhou Orthmay Advanced Materials Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | ECR |
| Device type | Setter, Band, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2019-09-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1060829 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Retainer Retriever | Dentsply Sirona Orthodontics Inc. | 6 |
| Young Specialties | Young Innovations Inc. | 6 |
| Benco | Benco Dental Supply Co. | 4 |
| Propel | Propel Orthodontics, LLC | 4 |
| Morelli | Dental Morelli Ltda. | 4 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 3 |
| Safco Contour matrix bands | Safco Dental Supply | 3 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 3 |
| J&J Instruments | J & J Instruments, LLC | 2 |
| Universal Solder | Produits dentaires S.A. | 2 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 2 |
| Orthoquest | Young Innovations Inc. | 2 |
Showing 12 of 21. All products under Setter, Band, Orthodontic
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.