Maestro®
Mini .022 UR7 NC Std -14T 0A 10DO
34manufacturers in China registered for this device type
112catalogue 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 | 2019-09-30 |
| Record revised | 2025-12-30 (version 4) |
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 |
|---|---|---|
| 902-301DB-5 | In distribution | |
| 911-314-10 | In distribution | |
| 902-302DB-10 | In distribution | |
| 911-357-10 | In distribution | |
| 911-263DB-10 | In distribution | |
| 902-353-10 | In distribution | |
| 902-302-10 | In distribution | |
| 911-214DB-10 | In distribution | |
| 911-262-10 | In distribution | |
| 911-362-10 | In distribution | |
| 911-323DB-10 | In distribution | |
| 911-373DB-10 | In distribution | |
| 911-211DB-10 | In distribution | |
| 911-264DB-10 | In distribution | |
| 902-303-10 | In distribution | |
| 911-258DB-10 | In distribution | |
| 902-202-10 | In distribution | |
| 902-304DB-5 | In distribution | |
| 902-251DB-10 | In distribution | |
| 911-257DB-10 | In distribution | |
| 911-324DB-10 | In distribution | |
| 902-252-10 | In distribution | |
| 911-274DB-10 | In distribution | |
| 911-263-10 | In distribution | |
| 911-357DB-10 | In distribution | |
| 911-358-10 | In distribution | |
| 911-364-10 | In distribution | |
| 911-271DB-10 | In distribution | |
| 902-351DB-5 | In distribution | |
| 911-361-10 | In distribution | |
| 911-356DB-10 | In distribution | |
| 911-314DB-10 | In distribution | |
| 902-351DB-10 | In distribution | |
| 911-273DB-10 | In distribution | |
| 911-364DB-10 | In distribution | |
| 911-213DB-10 | In distribution | |
| 911-206-10 | In distribution | |
| 902-354DB-5 | In distribution | |
| 902-253-10 | In distribution | |
| 911-363-10 | In distribution | |
| 911-272DB-10 | In distribution | |
| 902-254-10 | In distribution | |
| 902-352DB-5 | In distribution | |
| 902-352-10 | In distribution | |
| 902-204-10 | In distribution | |
| 911-261DB-10 | In distribution | |
| 902-351-10 | In distribution | |
| 911-355-10 | In distribution | |
| 911-211-10 | In distribution | |
| 911-312DB-10 | In distribution | |
| 911-224DB-10 | In distribution | |
| 902-352DB-10 | In distribution | |
| 911-362DB-10 | In distribution | |
| 902-354DB-10 | In distribution | |
| 911-222DB-10 | In distribution | |
| 911-256-10 | In distribution | |
| 911-371DB-10 | In distribution | |
| 911-221DB-10 | In distribution | |
| 902-253DB-10 | In distribution | |
| 902-203-10 | In distribution | |
| 911-257-10 | In distribution | |
| 902-251-10 | In distribution | |
| 911-306-10 | In distribution | |
| 902-204DB-10 | In distribution | |
| 902-254DB-10 | In distribution | |
| 911-313DB-10 | In distribution | |
| 902-301-10 | In distribution | |
| 902-201DB-10 | In distribution | |
| 911-205-10 | In distribution | |
| 902-303DB-10 | In distribution | |
| 911-311DB-10 | In distribution | |
| 902-304-10 | In distribution | |
| 911-262DB-10 | In distribution | |
| 911-322DB-10 | In distribution | |
| 911-356-10 | In distribution | |
| 911-223DB-10 | In distribution | |
| 911-261-10 | In distribution | |
| 902-201-10 | In distribution | |
| 911-311-10 | In distribution | |
| 902-203DB-10 | In distribution | |
| 902-353DB-10 | In distribution | |
| 911-264-10 | In distribution | |
| 902-303DB-5 | In distribution | |
| 911-206DB-10 | In distribution | |
| 911-258-10 | In distribution | |
| 902-301DB-10 | In distribution | |
| 911-255DB-10 | In distribution | |
| 911-305DB-10 | In distribution | |
| 911-212-10 | In distribution | |
| 911-361DB-10 | In distribution | |
| 911-355DB-10 | In distribution | |
| 911-321DB-10 | In distribution | |
| 911-256DB-10 | In distribution | |
| 902-353DB-5 | In distribution | |
| 911-312-10 | In distribution | |
| 911-214-10 | In distribution | |
| 902-202DB-10 | In distribution | |
| 911-212DB-10 | In distribution | |
| 911-363DB-10 | In distribution | |
| 911-205DB-10 | In distribution | |
| 911-305-10 | In distribution | |
| 911-255-10 | In distribution | |
| 911-372DB-10 | In distribution | |
| 911-313-10 | In distribution | |
| 911-358DB-10 | In distribution | |
| 902-304DB-10 | In distribution | |
| 902-302DB-5 | In distribution | |
| 902-252DB-10 | In distribution | |
| 911-213-10 | In distribution | |
| 911-374DB-10 | In distribution | |
| 902-354-10 | In distribution | |
| 911-306DB-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.