Maestro® Band Assemblies
Maestro® .022 UR7 NC CBTStd BT-10T/0A 10DO Tempra -Cleat (E)
27manufacturers in China registered for this device type
233catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (17), Jiangsu (4), Guangdong (4). 6 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 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 27. All 27 manufacturers in China registered for Band, Preformed, Orthodontic
Record
| Listed by | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, 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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 911-311091E-30.5 | In distribution | ||
| 911-361091E-40 | In distribution | ||
| 902-30306E-3 | In distribution | ||
| 902-35206E | In distribution | ||
| 911-312091E-31 | In distribution | ||
| 902-35406E | In distribution | ||
| 911-362091E-36 | In distribution | ||
| 911-312091E-32.5 | In distribution | ||
| 911-361091E-44 | In distribution | ||
| 902-353082E | In distribution | ||
| 902-303061E | In distribution | ||
| 911-311091E-3 | In distribution | ||
| 911-362091E-36.5 | In distribution | ||
| 911-312091E-44 | In distribution | ||
| 902-35306E-3 | In distribution | ||
| 902-30408E | In distribution | ||
| 902-304066E-3 | In distribution | ||
| 911-362091E-32 | In distribution | ||
| 911-311091E-43.5 | In distribution | ||
| 911-362091E-41.5 | In distribution | ||
| 911-361091E-38 | In distribution | ||
| 902-304083E-3 | 3 | In distribution | |
| 902-30308E | In distribution | ||
| 902-303083E-3 | 3 | In distribution | |
| 911-311091E-34.5 | In distribution | ||
| 902-303066E | In distribution | ||
| 911-361091E-34 | In distribution | ||
| 902-203081E | In distribution | ||
| 911-311091E-38.5 | In distribution | ||
| 902-35206E-3 | In distribution | ||
| 911-312091E-35 | In distribution | ||
| 902-304063E-3 | In distribution | ||
| 902-35108E | In distribution | ||
| 911-312091E-34 | In distribution | ||
| 911-362091E-3 | In distribution | ||
| 911-362091E-32.5 | In distribution | ||
| 902-35308E | In distribution | ||
| 902-30206E | In distribution | ||
| 902-30308E-3 | In distribution | ||
| 911-361091E-41.5 | In distribution | ||
| 902-20208E-3 | In distribution | ||
| 902-351061E-3 | In distribution | ||
| 911-313071E-3 | In distribution | ||
| 911-312091E-33.5 | In distribution | ||
| 911-362091E-39.5 | In distribution | ||
| 902-201083E-3 | In distribution | ||
| 911-311091E-35 | In distribution | ||
| 902-302061E | In distribution | ||
| 902-201083E | In distribution | ||
| 911-362091E-38 | In distribution | ||
| 911-361091E-43.5 | In distribution | ||
| 911-312091E-38.5 | In distribution | ||
| 911-362091E-30.5 | In distribution | ||
| 902-303081E-3 | In distribution | ||
| 911-362091E-41 | In distribution | ||
| 902-30306E | In distribution | ||
| 911-362091E-42 | In distribution | ||
| 902-353063E-3 | In distribution | ||
| 911-361091E-3 | In distribution | ||
| 902-30406E-3 | In distribution | ||
| 911-262091E | In distribution | ||
| 911-362091E-43.5 | In distribution | ||
| 911-311091E-36.5 | In distribution | ||
| 911-312091E-36.5 | In distribution | ||
| 911-312091E-38 | In distribution | ||
| 902-35106E-3 | In distribution | ||
| 911-312091E-41.5 | In distribution | ||
| 911-311091E-38 | In distribution | ||
| 902-354082E | In distribution | ||
| 911-361091E-43 | In distribution | ||
| 911-311091E-33 | In distribution | ||
| 911-362091E-33.5 | In distribution | ||
| 911-311091E-31.5 | In distribution | ||
| 911-311091E-35.5 | In distribution | ||
| 911-311091E-40.5 | In distribution | ||
| 911-312091E-43 | In distribution | ||
| 911-312091E-39.5 | In distribution | ||
| 902-35308E-3 | In distribution | ||
| 911-311091E-32 | In distribution | ||
| 902-30108E | In distribution | ||
| 902-202083E-3 | In distribution | ||
| 911-361091E-36.5 | In distribution | ||
| 902-353063E | In distribution | ||
| 902-303066E-3 | In distribution | ||
| 902-30408E-3 | In distribution | ||
| 911-311091E-31 | In distribution | ||
| 911-362091E-37 | In distribution | ||
| 911-361091E-41 | In distribution | ||
| 902-353083E-3 | 3 | In distribution | |
| 902-254081E-3 | In distribution | ||
| 911-361091E-37.5 | In distribution | ||
| 911-362091E-40.5 | In distribution | ||
| 911-312091E-41 | In distribution | ||
| 902-35108E-3 | In distribution | ||
| 911-211091E | In distribution | ||
| 911-312091E-43.5 | In distribution | ||
| 911-313071E | In distribution | ||
| 911-362091E-37.5 | In distribution | ||
| 911-364071E | In distribution | ||
| 902-301061E | In distribution | ||
| 911-312091E | In distribution | ||
| 902-204081E-3 | In distribution | ||
| 911-362091E-33 | In distribution | ||
| 911-361091E-35 | In distribution | ||
| 911-311091E-44 | In distribution | ||
| 911-212091E-3 | In distribution | ||
| 911-361091E-42.5 | In distribution | ||
| 911-362091E-42.5 | In distribution | ||
| 911-312091E-3 | In distribution | ||
| 911-361091E-33.5 | In distribution | ||
| 911-363071E | In distribution | ||
| 902-35208E | In distribution | ||
| 902-204081E | In distribution | ||
| 911-311091E-43 | In distribution | ||
| 911-362091E-35.5 | In distribution | ||
| 902-35408E | In distribution | ||
| 911-361091E-39 | In distribution | ||
| 911-211091E-3 | In distribution | ||
| 911-311091E-42 | In distribution | ||
| 902-35408E-3 | In distribution | ||
| 902-20108E | In distribution | ||
| 911-311091E-32.5 | In distribution | ||
| 911-362091E-31 | In distribution | ||
| 902-354081E | In distribution | ||
| 911-362091E-31.5 | In distribution | ||
| 902-304081E-3 | In distribution | ||
| 911-311091E-39.5 | In distribution | ||
| 902-304063E | In distribution | ||
| 911-361091E-35.5 | In distribution | ||
| 902-354063E-3 | In distribution | ||
| 911-362091E | In distribution | ||
| 911-312091E-31.5 | In distribution | ||
| 902-20108E-3 | In distribution | ||
| 911-362091E-38.5 | In distribution | ||
| 902-35306E | In distribution | ||
| 911-364071E-3 | In distribution | ||
| 902-304061E-3 | In distribution | ||
| 911-312091E-37.5 | In distribution | ||
| 902-35208E-3 | In distribution | ||
| 911-311091E-40 | In distribution | ||
| 902-354063E | In distribution | ||
| 911-311091E-37 | In distribution | ||
| 911-362091E-43 | In distribution | ||
| 911-361091E-36 | In distribution | ||
| 902-254081E | In distribution | ||
| 911-312091E-33 | In distribution | ||
| 902-30208E | In distribution | ||
| 911-311091E-39 | In distribution | ||
| 911-361091E-31.5 | In distribution | ||
| 902-353081E-3 | In distribution | ||
| 902-353061E | In distribution | ||
| 902-35406E-3 | In distribution | ||
| 911-311091E-33.5 | In distribution | ||
| 911-362091E-35 | In distribution | ||
| 902-30208E-3 | In distribution | ||
| 911-312091E-37 | In distribution | ||
| 911-262091E-3 | In distribution | ||
| 911-361091E-34.5 | In distribution | ||
| 911-314071E | In distribution | ||
| 911-311091E-41 | In distribution | ||
| 911-312091E-35.5 | In distribution | ||
| 911-362091E-40 | In distribution | ||
| 911-312091E-39 | In distribution | ||
| 911-311091E-36 | In distribution | ||
| 902-304081E | In distribution | ||
| 911-361091E-29.5 | In distribution | ||
| 902-352061E-3 | In distribution | ||
| 911-361091E-30.5 | In distribution | ||
| 911-312091E-36 | In distribution | ||
| 911-312091E-32 | In distribution | ||
| 902-253081E-3 | In distribution | ||
| 911-361091E-32 | In distribution | ||
| 911-362091E-29.5 | In distribution | ||
| 911-311091E-29.5 | In distribution | ||
| 911-311091E-42.5 | In distribution | ||
| 911-311091E-30 | In distribution | ||
| 911-311091E-37.5 | In distribution | ||
| 902-304061E | In distribution | ||
| 911-312091E-30.5 | In distribution | ||
| 902-301061E-3 | In distribution | ||
| 911-361091E-42 | In distribution | ||
| 902-303063E | In distribution | ||
| 911-314071E-3 | In distribution | ||
| 911-312091E-30 | In distribution | ||
| 911-362091E-44 | In distribution | ||
| 902-30206E-3 | In distribution | ||
| 902-354082E-3 | In distribution | ||
| 911-362091E-30 | In distribution | ||
| 911-311091E-34 | In distribution | ||
| 911-361091E | In distribution | ||
| 911-361091E-32.5 | In distribution | ||
| 902-354061E | In distribution | ||
| 911-361091E-31 | In distribution | ||
| 902-20208E | In distribution | ||
| 902-304066E | In distribution | ||
| 902-30108E-3 | In distribution | ||
| 902-30106E | In distribution | ||
| 902-30406E | In distribution | ||
| 911-312091E-40.5 | In distribution | ||
| 911-312091E-40 | In distribution | ||
| 911-361091E-39.5 | In distribution | ||
| 902-352061E | In distribution | ||
| 911-261091E-3 | In distribution | ||
| 902-353061E-3 | In distribution | ||
| 902-353081E | In distribution | ||
| 902-354061E-3 | In distribution | ||
| 902-302061E-3 | In distribution | ||
| 902-353082E-3 | In distribution | ||
| 911-311091E | In distribution | ||
| 911-261091E | In distribution | ||
| 911-363071E-3 | In distribution | ||
| 902-303063E-3 | In distribution | ||
| 911-361091E-40.5 | In distribution | ||
| 902-354081E-3 | In distribution | ||
| 911-312091E-34.5 | In distribution | ||
| 911-362091E-34.5 | In distribution | ||
| 911-362091E-34 | In distribution | ||
| 911-361091E-30 | In distribution | ||
| 911-361091E-33 | In distribution | ||
| 902-253081E | In distribution | ||
| 902-303081E | In distribution | ||
| 911-311091E-41.5 | In distribution | ||
| 902-354083E-3 | 3 | In distribution | |
| 911-361091E-37 | In distribution | ||
| 902-202083E | In distribution | ||
| 902-203081E-3 | In distribution | ||
| 911-361091E-38.5 | In distribution | ||
| 902-351061E | In distribution | ||
| 911-312091E-42.5 | In distribution | ||
| 911-362091E-39 | In distribution | ||
| 902-35106E | In distribution | ||
| 902-30106E-3 | In distribution | ||
| 902-303061E-3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Band, Preformed, Orthodontic | Forestadent Bernhard Förster GmbH | 8,646 |
| TruFit 2.0 | Ortho Technology, Inc. | 4,890 |
| TruFit™ | Ortho Organizers, Inc. | 3,943 |
| Leone SPA | Leone SPA | 2,549 |
| dentaform® | Dentaurum GmbH & Co. KG | 1,763 |
| Band Assemblies | Ortho Organizers, Inc. | 1,642 |
| 3M™ Victory Series™ | 3M Unitek | 1,388 |
| The Orthodontic Store | Young Innovations Inc. | 925 |
| Elite® Band Assemblies | Ortho Organizers, Inc. | 924 |
| TruFit™ 2.0 | Ortho Organizers, Inc. | 916 |
| 3M™ Unitek™ | 3M Unitek | 771 |
| Elite | Ortho Organizers, Inc. | 722 |
Showing 12 of 154. All products under Band, Preformed, 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.