Driver, Band, Orthodontic
Hard metal tip, straight (for Eby band seater REF 051-023-00)
4manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | ECT |
| Device type | Driver, Band, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2022-05-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Distribution end date | 2022-06-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 051-024-00 | Withdrawn | |
| 051-025-00 | Withdrawn | |
| 051-023-00 | Withdrawn | |
| 051-022-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthodontic Driver | Dentos, Incorporated | 27 |
| 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 |
| Mallet | Surgident 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.