SnapLink
U6L SNAPLINK.022 -18/0/+12
34manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (20), Jiangsu (4), Guangdong (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 34. All 34 manufacturers in China registered for Tube, Orthodontic
Record
| Listed by | Ormco Corporation, United States |
|---|---|
| FDA product code | DZD |
| Device type | Tube, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 438-2161 | Slot size:.022, Torque: -18, Angulation: 0, Rotation: +12 | 10 | In distribution |
| 438-2190 | Slot size:.022, Torque: -28, Angulation: +2, Rotation: +2 | 10 | In distribution |
| 438-2160 | Slot size:.022, Torque: -18, Angulation: 0, Rotation: +12 | 10 | In distribution |
| 438-2191 | Slot size:.022, Torque: -28, Angulation: +2, Rotation: +2 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tube, Orthodontic | Forestadent Bernhard Förster GmbH | 2,336 |
| Generic Buccal Tubes | American Orthodontics | 799 |
| Tube, Orthodontic | G & H Wire Company | 758 |
| Leone SPA | Leone SPA | 722 |
| RMO | RMO | 697 |
| Tube, Orthodontic | Dentaurum GmbH & Co. KG | 602 |
| LP Low Profile | American Orthodontics | 506 |
| 3M™ Unitek™ Victory Series™ | 3M Unitek | 434 |
| Buccal Tubes | American Orthodontics | 356 |
| Peerless Buccal Tube | Ormco Corporation | 331 |
| Empower Tube | American Orthodontics | 296 |
| Mini Master Series | American Orthodontics | 289 |
Showing 12 of 333. All products under Tube, Orthodontic
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ormco/Sybronendo | UDI-DI | 2020-01-17 | Class II | Device Design | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay trea | 3,632,493 brackets | 2024-09-30 |
| Ormco/Sybronendo | UDI-DI | 2020-01-17 | Class II | Device Design | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay trea | 3,632,493 brackets | 2024-09-30 |
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.