Ortho Specialties
Anatomical Molar Bands, Upper Right 1St & 2Nd Molars, Size 30.5 (Welded)
27manufacturers in China registered for this device type
443catalogue 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 | Young Innovations 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, Complaint-file establishment, Manufacturer |
| Record published | 2022-11-02 |
| Record revised | 2024-04-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Inner pack, package |
| Distribution end date | 2024-04-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 764-370 | In distribution | |
| 760-615W | In distribution | |
| 760-616W | In distribution | |
| 765-305W | In distribution | |
| 763-380 | In distribution | |
| 760-805 | In distribution | |
| 765-380 | In distribution | |
| 763-360W | In distribution | |
| 763-320W | In distribution | |
| 764-415W | In distribution | |
| 765-410 | In distribution | |
| 775-385 | In distribution | |
| 760-714 | In distribution | |
| 760-603W | In distribution | |
| 762-340 | In distribution | |
| 762-360 | In distribution | |
| 762-345W | In distribution | |
| 764-310 | In distribution | |
| 765-310 | In distribution | |
| 763-425 | In distribution | |
| 760-516 | In distribution | |
| 760-514W | In distribution | |
| 760-812W | In distribution | |
| 765-315 | In distribution | |
| 765-400 | In distribution | |
| 760-821W | In distribution | |
| 764-340W | In distribution | |
| 762-380 | In distribution | |
| 762-295W | In distribution | |
| 760-522 | In distribution | |
| 764-370W | In distribution | |
| 762-375 | In distribution | |
| 760-308W | In distribution | |
| 760-522W | In distribution | |
| 764-315W | In distribution | |
| 760-606 | In distribution | |
| 760-509W | In distribution | |
| 764-330 | In distribution | |
| 760-506W | In distribution | |
| 760-504 | In distribution | |
| 765-300 | In distribution | |
| 762-340W | In distribution | |
| 764-335 | In distribution | |
| 760-720 | In distribution | |
| 775-375 | In distribution | |
| 775-370 | In distribution | |
| 763-305W | In distribution | |
| 764-405W | In distribution | |
| 765-385W | In distribution | |
| 760-714W | In distribution | |
| 763-370 | In distribution | |
| 755-212W | In distribution | |
| 763-335 | In distribution | |
| 764-320W | In distribution | |
| 760-505W | In distribution | |
| 764-320 | In distribution | |
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| 765-370W | In distribution | |
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| 763-375W | In distribution | |
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| 765-295 | In distribution | |
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| 762-345 | In distribution | |
| 762-310W | In distribution | |
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| 765-385 | In distribution | |
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| 765-405W | In distribution | |
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| 764-355 | In distribution | |
| 762-390W | In distribution | |
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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.