Trimline
Lower Right AND Left 1ST Molar Trimline Band Size 5 -36
27manufacturers in China registered for this device type
256catalogue 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 | 2022-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 479-0031 | Band Size 31 | In distribution |
| 486-0028 | Band Size 28 | In distribution |
| 488-0015 | Band Size 15 | In distribution |
| 487-0006 | Band Size 6 | In distribution |
| 489-0007 | Band Size 7 | In distribution |
| 489-0006 | Band Size 6 | In distribution |
| 480-0036 | Band Size 36 | In distribution |
| 435-0026 | Band Size 26 | In distribution |
| 435-0019 | Band Size 19 | In distribution |
| 489-0030 | Band Size 30 | In distribution |
| 488-0031 | Band Size 31 | In distribution |
| 480-0024 | Band Size 24 | In distribution |
| 479-0023 | Band Size 23 | In distribution |
| 480-0015 | Band Size 15 | In distribution |
| 434-0034 | Band Size 34 | In distribution |
| 480-0012 | Band Size 12 | In distribution |
| 486-0024 | Band Size 24 | In distribution |
| 488-0016 | Band Size 16 | In distribution |
| 486-0015 | Band Size 15 | In distribution |
| 479-0005 | Band Size 5 | In distribution |
| 488-0020 | Band Size 20 | In distribution |
| 480-0030 | Band Size 30 | In distribution |
| 487-0005 | Band Size 5 | In distribution |
| 479-0006 | Band Size 6 | In distribution |
| 488-0030 | Band Size 30 | In distribution |
| 489-0005 | Band Size 5 | In distribution |
| 486-0097 | Band Size 97 | In distribution |
| 486-0007 | Band Size 7 | In distribution |
| 488-0011 | Band Size 11 | In distribution |
| 434-0020 | Band Size 20 | In distribution |
| 487-0004 | Band Size 4 | In distribution |
| 479-0028 | Band Size 28 | In distribution |
| 487-0018 | Band Size 18 | In distribution |
| 480-0016 | Band Size 16 | In distribution |
| 489-0028 | Band Size 28 | In distribution |
| 488-0022 | Band Size 22 | In distribution |
| 488-0018 | Band Size 18 | In distribution |
| 487-0007 | Band Size 7 | In distribution |
| 487-0098 | Band Size 98 | In distribution |
| 434-0016 | Band Size 16 | In distribution |
| 480-0025 | Band Size 25 | In distribution |
| 487-0024 | Band Size 24 | In distribution |
| 479-0025 | Band Size 25 | In distribution |
| 487-0013 | Band Size 13 | In distribution |
| 489-0019 | Band Size 19 | In distribution |
| 489-0031 | Band Size 31 | In distribution |
| 480-0031 | Band Size 31 | In distribution |
| 479-0024 | Band Size 24 | In distribution |
| 488-0001 | Band Size 1 | In distribution |
| 488-0026 | Band Size 26 | In distribution |
| 489-0010 | Band Size 10 | In distribution |
| 489-0023 | Band Size 23 | In distribution |
| 435-0024 | Band Size 24 | In distribution |
| 489-0015 | Band Size 15 | In distribution |
| 486-0020 | Band Size 20 | In distribution |
| 486-0019 | Band Size 19 | In distribution |
| 434-0017 | Band Size 17 | In distribution |
| 487-0000 | Band Size 0 | In distribution |
| 480-0014 | Band Size 14 | In distribution |
| 480-0013 | Band Size 13 | In distribution |
| 488-0010 | Band Size 10 | In distribution |
| 434-0011 | Band Size 11 | In distribution |
| 434-0023 | Band Size 23 | In distribution |
| 479-0036 | Band Size 36 | In distribution |
| 486-0004 | Band Size 4 | In distribution |
| 489-0016 | Band Size 16 | In distribution |
| 480-0019 | Band Size 19 | In distribution |
| 487-0011 | Band Size 11 | In distribution |
| 487-0019 | Band Size 19 | In distribution |
| 480-0007 | Band Size 7 | In distribution |
| 487-0027 | Band Size 27 | In distribution |
| 486-0099 | Band Size 99 | In distribution |
| 487-0010 | Band Size 10 | In distribution |
| 489-0017 | Band Size 17 | In distribution |
| 434-0029 | Band Size 29 | In distribution |
| 435-0005 | Band Size 5 | In distribution |
| 486-0025 | Band Size 25 | In distribution |
| 486-0002 | Band Size 2 | In distribution |
| 488-0028 | Band Size 28 | In distribution |
| 488-0002 | Band Size 2 | In distribution |
| 486-0012 | Band Size 12 | In distribution |
| 486-0009 | Band Size 9 | In distribution |
| 435-0011 | Band Size 11 | In distribution |
| 489-0014 | Band Size 14 | In distribution |
| 486-0013 | Band Size 13 | In distribution |
| 479-0034 | Band Size 34 | In distribution |
| 435-0030 | Band Size 30 | In distribution |
| 486-0021 | Band Size 21 | In distribution |
| 480-0010 | Band Size 10 | In distribution |
| 486-0005 | Band Size 5 | In distribution |
| 488-0007 | Band Size 7 | In distribution |
| 487-0026 | Band Size 26 | In distribution |
| 435-0022 | Band Size 22 | In distribution |
| 488-0004 | Band Size 4 | In distribution |
| 480-0020 | Band Size 20 | In distribution |
| 435-0033 | Band Size 33 | In distribution |
| 489-0024 | Band Size 24 | In distribution |
| 487-0015 | Band Size 15 | In distribution |
| 480-0008 | Band Size 8 | In distribution |
| 480-0028 | Band Size 28 | In distribution |
| 488-0024 | Band Size 24 | In distribution |
| 434-0015 | Band Size 15 | In distribution |
| 434-0014 | Band Size 14 | In distribution |
| 489-0009 | Band Size 9 | In distribution |
| 435-0036 | Band Size 36 | In distribution |
| 488-0021 | Band Size 21 | In distribution |
| 488-0019 | Band Size 19 | In distribution |
| 489-0003 | Band Size 3 | In distribution |
| 479-0033 | Band Size 33 | In distribution |
| 479-0015 | Band Size 15 | In distribution |
| 486-0008 | Band Size 8 | In distribution |
| 479-0013 | Band Size 13 | In distribution |
| 479-0027 | Band Size 27 | In distribution |
| 480-0018 | Band Size 18 | In distribution |
| 434-0032 | Band Size 32 | In distribution |
| 487-0016 | Band Size 16 | In distribution |
| 435-0006 | Band Size 6 | In distribution |
| 479-0010 | Band Size 10 | In distribution |
| 479-0017 | Band Size 17 | In distribution |
| 434-0035 | Band Size 35 | In distribution |
| 434-0031 | Band Size 31 | In distribution |
| 486-0014 | Band Size 14 | In distribution |
| 479-0021 | Band Size 21 | In distribution |
| 435-0031 | Band Size 31 | In distribution |
| 479-0009 | Band Size 9 | In distribution |
| 486-0023 | Band Size 23 | In distribution |
| 487-0012 | Band Size 12 | In distribution |
| 479-0018 | Band Size 18 | In distribution |
| 434-0008 | Band Size 8 | In distribution |
| 434-0036 | Band Size 36 | In distribution |
| 480-0009 | Band Size 9 | In distribution |
| 487-0097 | Band Size 97 | In distribution |
| 435-0035 | Band Size 35 | In distribution |
| 486-0001 | Band Size 1 | In distribution |
| 479-0019 | Band Size 19 | In distribution |
| 434-0030 | Band Size 30 | In distribution |
| 479-0012 | Band Size 12 | In distribution |
| 480-0033 | Band Size 33 | In distribution |
| 487-0028 | Band Size 28 | In distribution |
| 487-0025 | Band Size 25 | In distribution |
| 479-0016 | Band Size 16 | In distribution |
| 486-0027 | Band Size 27 | In distribution |
| 489-0020 | Band Size 20 | In distribution |
| 480-0026 | Band Size 26 | In distribution |
| 434-0012 | Band Size 12 | In distribution |
| 488-0012 | Band Size 12 | In distribution |
| 489-0011 | Band Size 11 | In distribution |
| 435-0014 | Band Size 14 | In distribution |
| 489-0026 | Band Size 26 | In distribution |
| 486-0010 | Band Size 10 | In distribution |
| 489-0004 | Band Size 4 | In distribution |
| 435-0034 | Band Size 34 | In distribution |
| 434-0022 | Band Size 22 | In distribution |
| 435-0032 | Band Size 32 | In distribution |
| 487-0023 | Band Size 23 | In distribution |
| 479-0011 | Band Size 11 | In distribution |
| 479-0008 | Band Size 8 | In distribution |
| 479-0007 | Band Size 7 | In distribution |
| 487-0003 | Band Size 3 | In distribution |
| 479-0020 | Band Size 20 | In distribution |
| 435-0021 | Band Size 21 | In distribution |
| 487-0099 | Band Size 99 | In distribution |
| 435-0012 | Band Size 12 | In distribution |
| 489-0018 | Band Size 18 | In distribution |
| 434-0021 | Band Size 21 | In distribution |
| 480-0006 | Band Size 6 | In distribution |
| 488-0006 | Band Size 6 | In distribution |
| 480-0023 | Band Size 23 | In distribution |
| 480-0027 | Band Size 27 | In distribution |
| 489-0013 | Band Size 13 | In distribution |
| 486-0022 | Band Size 22 | In distribution |
| 489-0032 | Band Size 32 | In distribution |
| 488-0032 | Band Size 32 | In distribution |
| 489-0008 | Band Size 8 | In distribution |
| 487-0009 | Band Size 9 | In distribution |
| 486-0026 | Band Size 26 | In distribution |
| 434-0026 | Band Size 26 | In distribution |
| 489-0029 | Band Size 29 | In distribution |
| 479-0035 | Band Size 35 | In distribution |
| 488-0023 | Band Size 23 | In distribution |
| 435-0027 | Band Size 27 | In distribution |
| 489-0027 | Band Size 27 | In distribution |
| 434-0028 | Band Size 28 | In distribution |
| 486-0011 | Band Size 11 | In distribution |
| 488-0009 | Band Size 9 | In distribution |
| 487-0022 | Band Size 22 | In distribution |
| 488-0013 | Band Size 13 | In distribution |
| 479-0022 | Band Size 22 | In distribution |
| 486-0098 | Band Size 98 | In distribution |
| 488-0008 | Band Size 8 | In distribution |
| 486-0018 | Band Size 18 | In distribution |
| 488-0017 | Band Size 17 | In distribution |
| 480-0029 | Band Size 29 | In distribution |
| 480-0032 | Band Size 32 | In distribution |
| 434-0007 | Band Size 7 | In distribution |
| 479-0026 | Band Size 26 | In distribution |
| 487-0014 | Band Size 14 | In distribution |
| 434-0009 | Band Size 9 | In distribution |
| 486-0006 | Band Size 6 | In distribution |
| 479-0014 | Band Size 14 | In distribution |
| 480-0011 | Band Size 11 | In distribution |
| 487-0001 | Band Size 1 | In distribution |
| 435-0023 | Band Size 23 | In distribution |
| 480-0021 | Band Size 21 | In distribution |
| 435-0020 | Band Size 20 | In distribution |
| 489-0001 | Band Size 1 | In distribution |
| 480-0022 | Band Size 22 | In distribution |
| 435-0015 | Band Size 15 | In distribution |
| 487-0008 | Band Size 8 | In distribution |
| 434-0033 | Band Size 33 | In distribution |
| 479-0030 | Band Size 30 | In distribution |
| 479-0032 | Band Size 32 | In distribution |
| 489-0002 | Band Size 2 | In distribution |
| 435-0007 | Band Size 7 | In distribution |
| 488-0027 | Band Size 27 | In distribution |
| 486-0017 | Band Size 17 | In distribution |
| 435-0008 | Band Size 8 | In distribution |
| 489-0012 | Band Size 12 | In distribution |
| 434-0025 | Band Size 25 | In distribution |
| 435-0018 | Band Size 18 | In distribution |
| 488-0005 | Band Size 5 | In distribution |
| 488-0014 | Band Size 14 | In distribution |
| 435-0025 | Band Size 25 | In distribution |
| 434-0013 | Band Size 13 | In distribution |
| 480-0005 | Band Size 5 | In distribution |
| 434-0010 | Band Size 10 | In distribution |
| 435-0013 | Band Size 13 | In distribution |
| 479-0029 | Band Size 29 | In distribution |
| 434-0027 | Band Size 27 | In distribution |
| 489-0025 | Band Size 25 | In distribution |
| 434-0006 | Band Size 6 | In distribution |
| 488-0025 | Band Size 25 | In distribution |
| 487-0021 | Band Size 21 | In distribution |
| 489-0022 | Band Size 22 | In distribution |
| 487-0002 | Band Size 2 | In distribution |
| 487-0017 | Band Size 17 | In distribution |
| 434-0024 | Band Size 24 | In distribution |
| 480-0034 | Band Size 34 | In distribution |
| 434-0018 | Band Size 18 | In distribution |
| 435-0028 | Band Size 28 | In distribution |
| 489-0021 | Band Size 21 | In distribution |
| 487-0020 | Band Size 20 | In distribution |
| 435-0010 | Band Size 10 | In distribution |
| 488-0003 | Band Size 3 | In distribution |
| 434-0019 | Band Size 19 | In distribution |
| 434-0005 | Band Size 5 | In distribution |
| 480-0017 | Band Size 17 | In distribution |
| 486-0000 | Band Size 0 | In distribution |
| 486-0016 | Band Size 16 | In distribution |
| 435-0016 | Band Size 16 | In distribution |
Showing 250 of 256 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.