TruFit™
TruFit 2.0 022 ROTH UL6 NC OCBT HG-OCC -10T 8DOff DB (10PK)
34manufacturers in China registered for this device type
100catalogue 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 492-11-4023 | 10 | In distribution | |
| 492-91-4610 | 10 | In distribution | |
| 492-12-2631 | 10 | In distribution | |
| 492-12-1610 | 10 | In distribution | |
| 492-12-1652 | 10 | In distribution | |
| 492-91-4631 | 10 | In distribution | |
| 492-22-3631 | 10 | In distribution | |
| 492-21-3631 | 10 | In distribution | |
| 492-51-1020 | 10 | In distribution | |
| 492-91-4020 | 10 | In distribution | |
| 492-11-2671 | 10 | In distribution | |
| 492-12-2682 | 10 | In distribution | |
| 492-92-4610 | 10 | In distribution | |
| 492-21-3610 | 10 | In distribution | |
| 492-12-1020 | 10 | In distribution | |
| 492-21-4610 | 10 | In distribution | |
| 492-12-2652 | 10 | In distribution | |
| 492-22-4023 | 10 | In distribution | |
| 492-21-3020 | 10 | In distribution | |
| 492-22-4020 | 10 | In distribution | |
| 492-22-3020 | 10 | In distribution | |
| 492-22-4631 | 10 | In distribution | |
| 492-92-4020 | 10 | In distribution | |
| 492-92-4691 | 10 | In distribution | |
| 492-51-2023 | 10 | In distribution | |
| 492-11-1023 | 10 | In distribution | |
| 492-21-1652 | 10 | In distribution | |
| 492-21-2020 | 10 | In distribution | |
| 492-22-2020 | 10 | In distribution | |
| 492-11-2023 | 10 | In distribution | |
| 492-52-2020 | 10 | In distribution | |
| 492-52-1020 | 10 | In distribution | |
| 492-21-4023 | 10 | In distribution | |
| 492-92-4631 | 10 | In distribution | |
| 492-52-3020 | 10 | In distribution | |
| 492-21-2652 | 10 | In distribution | |
| 492-11-1671 | 10 | In distribution | |
| 492-22-3023 | 10 | In distribution | |
| 492-21-2671 | 10 | In distribution | |
| 492-51-2020 | 10 | In distribution | |
| 492-52-4020 | 10 | In distribution | |
| 492-21-4020 | 10 | In distribution | |
| 492-22-2671 | 10 | In distribution | |
| 492-11-2672 | 10 | In distribution | |
| 492-22-1671 | 10 | In distribution | |
| 492-52-3023 | 10 | In distribution | |
| 492-92-3020 | 10 | In distribution | |
| 492-92-3691 | 10 | In distribution | |
| 492-22-2652 | 10 | In distribution | |
| 492-91-3020 | 10 | In distribution | |
| 492-91-3691 | 10 | In distribution | |
| 492-22-1652 | 10 | In distribution | |
| 492-51-3023 | 10 | In distribution | |
| 492-11-2682 | 10 | In distribution | |
| 492-22-2023 | 10 | In distribution | |
| 492-12-1671 | 10 | In distribution | |
| 492-12-1682 | 10 | In distribution | |
| 492-21-4631 | 10 | In distribution | |
| 492-11-1682 | 10 | In distribution | |
| 492-12-2023 | 10 | In distribution | |
| 492-21-2023 | 10 | In distribution | |
| 492-12-1631 | 10 | In distribution | |
| 492-11-2652 | 10 | In distribution | |
| 492-12-3023 | 10 | In distribution | |
| 492-11-1672 | 10 | In distribution | |
| 492-12-2671 | 10 | In distribution | |
| 492-11-1652 | 10 | In distribution | |
| 492-12-2610 | 10 | In distribution | |
| 492-11-2020 | 10 | In distribution | |
| 492-21-1020 | 10 | In distribution | |
| 492-12-2672 | 10 | In distribution | |
| 492-52-2023 | 10 | In distribution | |
| 492-51-4023 | 10 | In distribution | |
| 492-11-1631 | 10 | In distribution | |
| 492-12-1672 | 10 | In distribution | |
| 492-12-1023 | 10 | In distribution | |
| 492-22-3610 | 10 | In distribution | |
| 492-91-3610 | 10 | In distribution | |
| 492-11-1610 | 10 | In distribution | |
| 492-21-3023 | 10 | In distribution | |
| 492-91-4691 | 10 | In distribution | |
| 492-12-4023 | 10 | In distribution | |
| 492-22-4610 | 10 | In distribution | |
| 492-52-4023 | 10 | In distribution | |
| 492-21-1023 | 10 | In distribution | |
| 492-52-1023 | 10 | In distribution | |
| 492-11-3023 | 10 | In distribution | |
| 492-92-3631 | 10 | In distribution | |
| 492-21-1671 | 10 | In distribution | |
| 492-11-2610 | 10 | In distribution | |
| 492-22-1020 | 10 | In distribution | |
| 492-51-4020 | 10 | In distribution | |
| 492-51-1023 | 10 | In distribution | |
| 492-22-1023 | 10 | In distribution | |
| 492-91-3631 | 10 | In distribution | |
| 492-92-3610 | 10 | In distribution | |
| 492-11-1020 | 10 | In distribution | |
| 492-51-3020 | 10 | In distribution | |
| 492-12-2020 | 10 | In distribution | |
| 492-11-2631 | 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.