Buccal Tube Direct Bond
.018 UR6 Conv Com Buccal Tube Roth Ging DB
34manufacturers in China registered for this device type
12catalogue numbers in this listing
1recall
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 | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | DZD |
| Device type | Tube, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-13 |
| Record revised | 2025-12-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4016-408-10 | In distribution | |
| 4016-360-10 | In distribution | |
| 4016-112-10 | In distribution | |
| 4016-402-10 | In distribution | |
| 4016-008-10 | In distribution | |
| 4016-363-10 | In distribution | |
| 4016-132-10 | In distribution | |
| 4016-368-10 | In distribution | |
| 4016-128-10 | In distribution | |
| 4016-370-10 | In distribution | |
| 4016-371-10 | In distribution | |
| 4016-369-10 | 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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-11-01 | Not classified | Pending | Products were mis-labeled as nickel free. | 1300 | 2011-04-27 |
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.