The Orthodontic Store
Anatomical Molar Bands, Upper Left 1St & 2Nd Molars, Size 40.5 (Welded)
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 |
| Premarket notification | Exempt |
| Record published | 2022-11-02 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 716-365 | In distribution | |
| 714-385W | In distribution | |
| 770-809W | In distribution | |
| 713-395 | In distribution | |
| 714-345W | In distribution | |
| 722-390 | In distribution | |
| 711-305W | In distribution | |
| 770-813 | In distribution | |
| 755-123 | In distribution | |
| 760-219 | In distribution | |
| 760-411W | In distribution | |
| 770-432 | In distribution | |
| 770-622W | In distribution | |
| 770-617 | In distribution | |
| 770-201W | In distribution | |
| 770-331 | In distribution | |
| 714-350W | In distribution | |
| 770-316W | In distribution | |
| 770-519 | In distribution | |
| 711-355W | In distribution | |
| 770-404 | In distribution | |
| 715-390 | In distribution | |
| 760-419W | In distribution | |
| 760-432 | In distribution | |
| 722-385 | In distribution | |
| 770-424 | In distribution | |
| 770-812W | In distribution | |
| 770-827W | In distribution | |
| 712-405 | In distribution | |
| 721-345 | In distribution | |
| 770-413W | In distribution | |
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| 760-312W | In distribution | |
| 760-422 | In distribution | |
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| 770-326 | In distribution | |
| 770-822 | In distribution | |
| 770-313W | In distribution | |
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| 713-330 | In distribution | |
| 711-310W | In distribution | |
| 712-320W | In distribution | |
| 722-365W | In distribution | |
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| 770-215 | In distribution | |
| 712-330 | In distribution | |
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| 717-395 | In distribution | |
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| 713-430 | In distribution | |
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| 770-409 | In distribution | |
| 760-210 | In distribution | |
| 755-202 | In distribution | |
| 714-335 | In distribution | |
| 770-113 | In distribution | |
| 760-229W | In distribution | |
| 770-411W | In distribution | |
| 760-327W | In distribution | |
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| 770-428 | In distribution | |
| 711-395 | In distribution | |
| 760-301 | In distribution | |
| 760-127 | In distribution | |
| 760-316W | In distribution | |
| 713-375 | In distribution | |
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| 712-305 | In distribution | |
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| 760-116 | In distribution | |
| 770-327W | In distribution | |
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| 770-131W | In distribution | |
| 717-375 | In distribution | |
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| 770-125W | In distribution | |
| 770-219W | In distribution | |
| 712-330W | In distribution | |
| 712-295 | In distribution | |
| 713-310W | In distribution | |
| 770-323 | In distribution | |
| 714-395W | In distribution | |
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| 770-101W | In distribution | |
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| 760-427W | In distribution | |
| 760-308 | In distribution | |
| 770-117W | In distribution | |
| 718-370W | In distribution | |
| 722-395 | In distribution | |
| 770-211 | In distribution | |
| 760-131 | In distribution | |
| 755-107 | In distribution | |
| 760-214 | In distribution | |
| 711-315 | In distribution | |
| 770-620 | In distribution | |
| 715-345 | In distribution | |
| 770-227 | In distribution | |
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| 717-385 | In distribution | |
| 718-395 | In distribution | |
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| 760-227 | In distribution | |
| 770-307W | In distribution | |
| 760-117 | In distribution | |
| 770-820 | In distribution | |
| 770-117 | In distribution | |
| 770-410 | 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 |
| Elite® Band Assemblies | Ortho Organizers, Inc. | 924 |
| TruFit™ 2.0 | Ortho Organizers, Inc. | 916 |
| 3M™ Unitek™ | 3M Unitek | 771 |
| Elite | Ortho Organizers, Inc. | 722 |
| Rollo Bands | American Orthodontics | 660 |
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.