3m™ Unitek™
Unitek(TM) Light Wire BT V-Slot Combination UR6 6Off .036 6.5 mm/.045 4.5 mm Hk 5/Pk
34manufacturers in China registered for this device type
35catalogue 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 | 3M Unitek, United States |
|---|---|
| FDA product code | DZD |
| Device type | Tube, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2018-10-18 |
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 |
|---|---|---|---|
| 046-117 | 10 | In distribution | |
| 046-012 | 10 | In distribution | |
| 080-220 | 10 | In distribution | |
| 046-013 | 10 | In distribution | |
| 080-211 | 10 | In distribution | |
| 046-001 | 10 | In distribution | |
| 080-810 | 10 | In distribution | |
| 080-254 | 10 | In distribution | |
| 080-251 | 10 | In distribution | |
| 080-245 | 10 | In distribution | |
| 080-242 | 10 | In distribution | |
| 046-002 | 10 | In distribution | |
| 080-110 | 10 | In distribution | |
| 080-246 | 10 | In distribution | |
| 046-147 | 10 | In distribution | |
| 080-120 | 10 | In distribution | |
| 080-230 | 10 | In distribution | |
| 080-240 | 10 | In distribution | |
| 046-115 | 10 | In distribution | |
| 080-252 | 10 | In distribution | |
| 080-253 | 10 | In distribution | |
| 080-131 | 10 | In distribution | |
| 080-100 | 10 | In distribution | |
| 080-270 | 10 | In distribution | |
| 080-140 | 10 | In distribution | |
| 046-011 | 10 | In distribution | |
| 080-231 | 10 | In distribution | |
| 046-116 | 10 | In distribution | |
| 080-130 | 10 | In distribution | |
| 080-111 | 10 | In distribution | |
| 046-014 | 10 | In distribution | |
| 080-210 | 10 | In distribution | |
| 046-146 | 10 | In distribution | |
| 080-243 | 10 | In distribution | |
| 046-114 | 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
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.