Mallet
Catalogue number MT-414, listed by Surgident Co., Ltd., South Korea, under Driver, Band, Orthodontic. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1), Sichuan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chengdu Sani Medical Equipment Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 12 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Zhejiang Shinye Medical Technology Corp.,Ltd | Hangzhou | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Surgident Co., Ltd., South Korea |
|---|---|
| FDA product code | ECT |
| Device type | Driver, Band, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MT-414 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthodontic Driver | Dentos, Incorporated | 27 |
| Driver, Band, Orthodontic | Dentaurum GmbH & Co. KG | 4 |
| Tac Remover Driver | Surgident Co., Ltd. | 2 |
| Tac Applicator | Surgident Co., Ltd. | 2 |
| Driver Handle | Surgident Co., Ltd. | 2 |
| SA-002 | GNI Co., Ltd. | 1 |
| SA-100 | GNI Co., Ltd. | 1 |
| SA-005 | GNI Co., Ltd. | 1 |
| SA-006 | GNI Co., Ltd. | 1 |
| SA-001 | GNI Co., Ltd. | 1 |
| SA-003 | GNI Co., Ltd. | 1 |
| Simple Line | Dentium Co., Ltd. | 1 |
Showing 12 of 16. All products under Driver, 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.