American Orthodontics
AO USA Band Seater N114, DL HEX Handle
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 | Nordent Manufacturing Inc |
|---|---|
| FDA product code | ECR |
| Device type | Setter, Band, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-04-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 010-301 | 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.