Ultima
Lower Right Ultima Band Size 10
27manufacturers in China registered for this device type
128catalogue 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 | Ormco Corporation, United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 458-0005 | Band Size 5 | In distribution |
| 457-0007 | Band Size 7 | In distribution |
| 458-0023 | Band Size 23 | In distribution |
| 457-0006 | Band Size 6 | In distribution |
| 459-0010 | Band Size 10 | In distribution |
| 459-0028 | Band Size 28 | In distribution |
| 458-0006 | Band Size 6 | In distribution |
| 460-0031 | Band Size 31 | In distribution |
| 458-0034 | Band Size 34 | In distribution |
| 459-0025 | Band Size 25 | In distribution |
| 457-0031 | Band Size 31 | In distribution |
| 458-0029 | Band Size 29 | In distribution |
| 457-0036 | Band Size 36 | In distribution |
| 458-0028 | Band Size 28 | In distribution |
| 457-0018 | Band Size 18 | In distribution |
| 460-0034 | Band Size 34 | In distribution |
| 460-0023 | Band Size 23 | In distribution |
| 458-0020 | Band Size 20 | In distribution |
| 459-0030 | Band Size 30 | In distribution |
| 458-0012 | Band Size 12 | In distribution |
| 457-0005 | Band Size 5 | In distribution |
| 460-0021 | Band Size 21 | In distribution |
| 460-0020 | Band Size 20 | In distribution |
| 460-0006 | Band Size 6 | In distribution |
| 458-0021 | Band Size 21 | In distribution |
| 458-0022 | Band Size 22 | In distribution |
| 458-0036 | Band Size 36 | In distribution |
| 458-0018 | Band Size 18 | In distribution |
| 459-0017 | Band Size 17 | In distribution |
| 460-0035 | Band Size 35 | In distribution |
| 459-0023 | Band Size 23 | In distribution |
| 457-0020 | Band Size 20 | In distribution |
| 457-0017 | Band Size 17 | In distribution |
| 460-0018 | Band Size 18 | In distribution |
| 459-0014 | Band Size 14 | In distribution |
| 460-0007 | Band Size 7 | In distribution |
| 459-0006 | Band Size 6 | In distribution |
| 457-0027 | Band Size 27 | In distribution |
| 459-0009 | Band Size 9 | In distribution |
| 458-0032 | Band Size 32 | In distribution |
| 460-0005 | Band Size 5 | In distribution |
| 457-0026 | Band Size 26 | In distribution |
| 459-0005 | Band Size 5 | In distribution |
| 458-0007 | Band Size 7 | In distribution |
| 460-0013 | Band Size 13 | In distribution |
| 459-0032 | Band Size 32 | In distribution |
| 457-0021 | Band Size 21 | In distribution |
| 459-0021 | Band Size 21 | In distribution |
| 460-0014 | Band Size 14 | In distribution |
| 457-0029 | Band Size 29 | In distribution |
| 457-0030 | Band Size 30 | In distribution |
| 458-0035 | Band Size 35 | In distribution |
| 459-0031 | Band Size 31 | In distribution |
| 460-0024 | Band Size 24 | In distribution |
| 457-0009 | Band Size 9 | In distribution |
| 460-0022 | Band Size 22 | In distribution |
| 457-0028 | Band Size 28 | In distribution |
| 459-0012 | Band Size 12 | In distribution |
| 459-0011 | Band Size 11 | In distribution |
| 457-0015 | Band Size 15 | In distribution |
| 460-0036 | Band Size 36 | In distribution |
| 459-0008 | Band Size 8 | In distribution |
| 458-0031 | Band Size 31 | In distribution |
| 458-0030 | Band Size 30 | In distribution |
| 459-0036 | Band Size 36 | In distribution |
| 460-0030 | Band Size 30 | In distribution |
| 457-0012 | Band Size 12 | In distribution |
| 457-0032 | Band Size 32 | In distribution |
| 457-0023 | Band Size 23 | In distribution |
| 457-0022 | Band Size 22 | In distribution |
| 460-0016 | Band Size 16 | In distribution |
| 458-0010 | Band Size 10 | In distribution |
| 457-0010 | Band Size 10 | In distribution |
| 459-0027 | Band Size 27 | In distribution |
| 460-0017 | Band Size 17 | In distribution |
| 457-0011 | Band Size 11 | In distribution |
| 459-0024 | Band Size 24 | In distribution |
| 460-0008 | Band Size 8 | In distribution |
| 458-0009 | Band Size 9 | In distribution |
| 458-0027 | Band Size 27 | In distribution |
| 459-0018 | Band Size 18 | In distribution |
| 457-0013 | Band Size 13 | In distribution |
| 459-0007 | Band Size 7 | In distribution |
| 457-0016 | Band Size 16 | In distribution |
| 458-0014 | Band Size 14 | In distribution |
| 460-0009 | Band Size 9 | In distribution |
| 457-0025 | Band Size 25 | In distribution |
| 459-0029 | Band Size 29 | In distribution |
| 460-0027 | Band Size 27 | In distribution |
| 459-0033 | Band Size 33 | In distribution |
| 457-0024 | Band Size 24 | In distribution |
| 460-0019 | Band Size 19 | In distribution |
| 458-0015 | Band Size 15 | In distribution |
| 460-0025 | Band Size 25 | In distribution |
| 460-0032 | Band Size 32 | In distribution |
| 458-0016 | Band Size 16 | In distribution |
| 458-0024 | Band Size 24 | In distribution |
| 459-0020 | Band Size 20 | In distribution |
| 457-0014 | Band Size 14 | In distribution |
| 458-0011 | Band Size 11 | In distribution |
| 459-0015 | Band Size 15 | In distribution |
| 459-0035 | Band Size 35 | In distribution |
| 459-0026 | Band Size 26 | In distribution |
| 458-0017 | Band Size 17 | In distribution |
| 459-0016 | Band Size 16 | In distribution |
| 458-0026 | Band Size 26 | In distribution |
| 460-0029 | Band Size 29 | In distribution |
| 460-0028 | Band Size 28 | In distribution |
| 460-0012 | Band Size 12 | In distribution |
| 459-0013 | Band Size 13 | In distribution |
| 458-0008 | Band Size 8 | In distribution |
| 460-0015 | Band Size 15 | In distribution |
| 458-0019 | Band Size 19 | In distribution |
| 458-0025 | Band Size 25 | In distribution |
| 458-0013 | Band Size 13 | In distribution |
| 458-0033 | Band Size 33 | In distribution |
| 459-0034 | Band Size 34 | In distribution |
| 459-0022 | Band Size 22 | In distribution |
| 457-0035 | Band Size 35 | In distribution |
| 457-0008 | Band Size 8 | In distribution |
| 460-0011 | Band Size 11 | In distribution |
| 460-0010 | Band Size 10 | In distribution |
| 457-0019 | Band Size 19 | In distribution |
| 460-0033 | Band Size 33 | In distribution |
| 457-0034 | Band Size 34 | In distribution |
| 457-0033 | Band Size 33 | In distribution |
| 460-0026 | Band Size 26 | In distribution |
| 459-0019 | Band Size 19 | 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.