TruEase™
TruEase LP Tube .022 UR Bond Sgl NonConv Roth Rx -10° Tor 8° DO DB Ext Base(10PK)
34manufacturers in China registered for this device type
36catalogue 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 | 2025-10-23 |
| Record revised | 2025-12-30 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 460-22-2020 | 10 | In distribution | |
| 470-51-7720 | 10 | In distribution | |
| 460-11-1020 | 10 | In distribution | |
| 460-21-1020 | 10 | In distribution | |
| 470-21-7723 | 10 | In distribution | |
| 470-52-8720 | 10 | In distribution | |
| 460-11-4020 | 10 | In distribution | |
| 460-11-3020 | 10 | In distribution | |
| 460-12-1020 | 10 | In distribution | |
| 470-12-1720 | 10 | In distribution | |
| 460-11-2020 | 10 | In distribution | |
| 460-21-3020 | 10 | In distribution | |
| 470-12-4720 | 10 | In distribution | |
| 470-11-3720 | 10 | In distribution | |
| 470-52-7720 | 10 | In distribution | |
| 460-22-1020 | 10 | In distribution | |
| 460-12-4020 | 10 | In distribution | |
| 460-52-7020 | 10 | In distribution | |
| 470-22-7723 | 10 | In distribution | |
| 460-22-4020 | 10 | In distribution | |
| 470-12-3720 | 10 | In distribution | |
| 470-11-4720 | 10 | In distribution | |
| 470-11-1720 | 10 | In distribution | |
| 470-21-8723 | 10 | In distribution | |
| 460-51-7020 | 10 | In distribution | |
| 460-12-3020 | 10 | In distribution | |
| 460-12-2020 | 10 | In distribution | |
| 460-52-8020 | 10 | In distribution | |
| 470-12-2720 | 10 | In distribution | |
| 460-21-2020 | 10 | In distribution | |
| 460-22-3020 | 10 | In distribution | |
| 460-51-8020 | 10 | In distribution | |
| 470-11-2720 | 10 | In distribution | |
| 460-21-4020 | 10 | In distribution | |
| 470-51-8720 | 10 | In distribution | |
| 470-22-8723 | 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.