Pro-Max Bands
Bands 1st Molar UL 28: Orthodontic bands 1st Molar Upper Left , size 28
27manufacturers in China registered for this device type
312catalogue 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 Pro Dent LLC, United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2024-11-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature up to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B2-LR-385 | In distribution | |
| B1-LL-44 | In distribution | |
| B2-UL-285 | In distribution | |
| B2-UL-445 | In distribution | |
| B2-LR-39 | In distribution | |
| BS-180-000 | In distribution | |
| B1-UL-385 | In distribution | |
| B1-LL-28 | In distribution | |
| B1-UL-345 | In distribution | |
| B1-LL-455 | In distribution | |
| B1-LR-37 | In distribution | |
| B2-LR-315 | In distribution | |
| B1-UL-405 | In distribution | |
| B1-LL-305 | In distribution | |
| B2-LL-455 | In distribution | |
| B1-LR-39 | In distribution | |
| B1-UL-435 | In distribution | |
| B1-LR-445 | In distribution | |
| B1-LR-375 | In distribution | |
| B1-LR-30 | In distribution | |
| B1-UR-37 | In distribution | |
| B2-UL-415 | In distribution | |
| B2-LL-33 | In distribution | |
| B2-UL-44 | In distribution | |
| B1-LL-405 | In distribution | |
| B1-UR-38 | In distribution | |
| B1-LR-325 | In distribution | |
| B1-UL-285 | In distribution | |
| B1-UL-28 | In distribution | |
| B2-LL-345 | In distribution | |
| BS-18-000 | In distribution | |
| B2-UR-385 | In distribution | |
| B1-LR-305 | In distribution | |
| B1-LL-435 | In distribution | |
| B1-UR-325 | In distribution | |
| BS-22-000 | In distribution | |
| B2-UL-37 | In distribution | |
| B1-UL-33 | In distribution | |
| B2-LL-445 | In distribution | |
| B1-UL-445 | In distribution | |
| B2-UR-42 | In distribution | |
| B1-LR-38 | In distribution | |
| B2-LR-375 | In distribution | |
| B2-LL-42 | In distribution | |
| B1-LL-33 | In distribution | |
| B1-LR-385 | In distribution | |
| B1-UL-31 | In distribution | |
| B1-LL-425 | In distribution | |
| B2-LL-45 | In distribution | |
| B2-UR-34 | In distribution | |
| B2-UL-305 | In distribution | |
| B1-UR-375 | In distribution | |
| B1-UR-305 | In distribution | |
| B1-LL-285 | In distribution | |
| B2-UR-40 | In distribution | |
| B1-UL-29 | In distribution | |
| B2-LR-425 | In distribution | |
| B1-UR-31 | In distribution | |
| B2-UR-335 | In distribution | |
| B1-LR-28 | In distribution | |
| B2-LR-285 | In distribution | |
| BS-22-000 | In distribution | |
| B1-LL-335 | In distribution | |
| B1-LR-35 | In distribution | |
| B2-UL-315 | In distribution | |
| B1-UL-425 | In distribution | |
| B1-UR-35 | In distribution | |
| B1-UR-445 | In distribution | |
| B2-LR-395 | In distribution | |
| B1-UL-38 | In distribution | |
| B2-UL-455 | In distribution | |
| B1-UR-435 | In distribution | |
| B1-LL-395 | In distribution | |
| B1-UR-285 | In distribution | |
| B1-UR-36 | In distribution | |
| B1-LL-28 | In distribution | |
| B2-UR-29 | In distribution | |
| B1-LL-40 | In distribution | |
| B1-UR-29 | In distribution | |
| B2-UR-44 | In distribution | |
| B2-LL-405 | In distribution | |
| B1-UL-37 | In distribution | |
| B1-LR-345 | In distribution | |
| B2-UL-29 | In distribution | |
| B2-LL-375 | In distribution | |
| B1-UR-455 | In distribution | |
| B1-LR-45 | In distribution | |
| B1-LR-28 | In distribution | |
| B1-UR-345 | In distribution | |
| B2-LL-285 | In distribution | |
| B2-UL-38 | In distribution | |
| B2-UL-295 | In distribution | |
| B1-UL-00 | In distribution | |
| B2-LL-325 | In distribution | |
| B1-UL-34 | In distribution | |
| B2-LL-335 | In distribution | |
| B1-LR-335 | In distribution | |
| B2-LR-41 | In distribution | |
| B2-UR-285 | In distribution | |
| B2-LR-00 | In distribution | |
| B1-LL-385 | In distribution | |
| B1-UR-00 | In distribution | |
| B1-LR-00 | In distribution | |
| B1-UR-44 | In distribution | |
| B1-LR-36 | In distribution | |
| B2-LL-36 | In distribution | |
| B2-LL-41 | In distribution | |
| B2-UL-335 | In distribution | |
| B1-LL-38 | In distribution | |
| B1-UR-32 | In distribution | |
| B1-LR-41 | In distribution | |
| B2-LL-30 | In distribution | |
| B1-LL-345 | In distribution | |
| B2-UL-31 | In distribution | |
| B2-LL-385 | In distribution | |
| B2-UR-00 | In distribution | |
| B1-LL-325 | In distribution | |
| B2-UR-315 | In distribution | |
| B2-UL-34 | In distribution | |
| B2-UR-405 | In distribution | |
| B2-LL-37 | In distribution | |
| B2-UL-42 | In distribution | |
| B1-LR-435 | In distribution | |
| B1-LL-00 | In distribution | |
| BS-180-000 | In distribution | |
| B2-LL-35 | In distribution | |
| B2-UL-425 | In distribution | |
| B1-UL-295 | In distribution | |
| B1-LR-455 | In distribution | |
| B2-UR-36 | In distribution | |
| B2-LL-34 | In distribution | |
| B2-UR-295 | In distribution | |
| B2-UL-375 | In distribution | |
| B1-UR-30 | In distribution | |
| B2-LR-305 | In distribution | |
| B1-LR-44 | In distribution | |
| B2-UL-405 | In distribution | |
| B2-UR-28 | In distribution | |
| B1-UL-43 | In distribution | |
| B2-LL-395 | In distribution | |
| B1-UR-295 | In distribution | |
| B1-UL-44 | In distribution | |
| B1-LR-34 | In distribution | |
| B1-UL-30 | In distribution | |
| B2-UL-35 | In distribution | |
| B1-LL-375 | In distribution | |
| B1-LR-425 | In distribution | |
| B2-LL-43 | In distribution | |
| B2-UR-32 | In distribution | |
| B2-LR-31 | In distribution | |
| B2-UR-41 | In distribution | |
| B2-LR-42 | In distribution | |
| B1-UL-365 | In distribution | |
| B2-LR-455 | In distribution | |
| B2-LR-43 | In distribution | |
| B1-UR-28 | In distribution | |
| B2-UL-36 | In distribution | |
| B1-UL-36 | In distribution | |
| B1-UR-425 | In distribution | |
| B2-UL-385 | In distribution | |
| B1-LR-32 | In distribution | |
| BS-220-000 | In distribution | |
| B2-LL-355 | In distribution | |
| B2-LR-365 | In distribution | |
| B1-UL-39 | In distribution | |
| B1-UR-00 | In distribution | |
| B1-UR-335 | In distribution | |
| B2-LL-39 | In distribution | |
| B2-LL-435 | In distribution | |
| B2-LR-325 | In distribution | |
| B1-LR-315 | In distribution | |
| B1-UL-35 | In distribution | |
| B1-LR-285 | In distribution | |
| B2-LR-435 | In distribution | |
| B2-LL-28 | In distribution | |
| B1-LL-295 | In distribution | |
| B2-UL-355 | In distribution | |
| B2-LR-36 | In distribution | |
| B2-UR-375 | In distribution | |
| B1-UR-385 | In distribution | |
| B1-LL-34 | In distribution | |
| B2-LR-40 | In distribution | |
| B1-UL-305 | In distribution | |
| B2-LL-38 | In distribution | |
| B2-UL-395 | In distribution | |
| B2-UL-365 | In distribution | |
| B1-LR-42 | In distribution | |
| B1-LL-365 | In distribution | |
| B2-LR-33 | In distribution | |
| B1-UL-45 | In distribution | |
| B1-LL-355 | In distribution | |
| B2-UR-38 | In distribution | |
| B2-UR-33 | In distribution | |
| B2-UL-39 | In distribution | |
| B1-LL-445 | In distribution | |
| B1-UR-33 | In distribution | |
| B1-UR-365 | In distribution | |
| B1-LL-00 | In distribution | |
| B2-LR-38 | In distribution | |
| B2-UR-425 | In distribution | |
| B1-UR-28 | In distribution | |
| B1-UL-355 | In distribution | |
| B1-LL-315 | In distribution | |
| B1-LR-31 | In distribution | |
| B2-UL-32 | In distribution | |
| B2-UR-37 | In distribution | |
| B1-LR-00 | In distribution | |
| B2-UR-325 | In distribution | |
| B2-LL-305 | In distribution | |
| B1-UL-415 | In distribution | |
| B2-UL-41 | In distribution | |
| B1-UR-45 | In distribution | |
| B1-UL-28 | In distribution | |
| B2-UR-435 | In distribution | |
| B2-LR-29 | In distribution | |
| B1-LR-43 | In distribution | |
| B2-LL-295 | In distribution | |
| B1-UL-32 | In distribution | |
| B1-UR-42 | In distribution | |
| B1-LL-43 | In distribution | |
| B2-LL-415 | In distribution | |
| B1-LL-45 | In distribution | |
| B2-LR-415 | In distribution | |
| B2-LL-425 | In distribution | |
| B1-UR-41 | In distribution | |
| B1-LR-33 | In distribution | |
| B2-LR-30 | In distribution | |
| B1-LL-32 | In distribution | |
| B2-LR-45 | In distribution | |
| B2-LR-445 | In distribution | |
| B2-UL-40 | In distribution | |
| B1-LL-42 | In distribution | |
| B1-LL-29 | In distribution | |
| B2-UL-00 | In distribution | |
| B2-LR-345 | In distribution | |
| B1-LL-39 | In distribution | |
| B1-UR-355 | In distribution | |
| B2-UR-305 | In distribution | |
| B2-UR-345 | In distribution | |
| B2-LL-29 | In distribution | |
| B2-UR-395 | In distribution | |
| B1-UL-42 | In distribution | |
| B1-UL-325 | In distribution | |
| B2-LL-40 | In distribution | |
| B1-UL-375 | In distribution | |
| B2-UL-45 | In distribution | |
| B1-UL-40 | In distribution | |
| B2-UL-345 | In distribution | |
| B2-LL-32 | In distribution | |
| B2-LR-34 | In distribution |
Showing 250 of 300 catalogue numbers.
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.