Zoo Pack Elastic
ZOO Master Pouch 4H 5/16 14OZ Walrus
36manufacturers in China registered for this device type
53catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (8), Shanghai (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 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Zhejiang Risheng Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 8 |
| 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 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
Showing 12 of 36. All 36 manufacturers in China registered for Band, Elastic, Orthodontic
Record
| Listed by | Ormco Corporation, United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-04-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 635-0059 | 1/4inches, 6.35mm | 15 | In distribution |
| 634-0012 | 5/16inches, 7.94mm | 50 | In distribution |
| 630-0014 | 3/8inches, 9.35mm | 50 | In distribution |
| 634-0004 | 1/2inches, 12.7mm | 50 | In distribution |
| 635-0060 | 5/16inches, 7.94mm | 15 | In distribution |
| 634-0002 | 5/16inches, 7.94mm | 50 | In distribution |
| 630-0041 | 1/4inches, 6.35mm | 50 | In distribution |
| 630-0035 | 1/2inches, 12.7mm | 50 | In distribution |
| 636-0113 | 1/8inches, 3.18mm | 40 | In distribution |
| 635-0058 | 3/16inches, 4.76mm | 15 | In distribution |
| 630-0017 | 3/4inches, 19.1mm | 50 | In distribution |
| 635-0061 | 3/8inches, 9.35mm | 15 | In distribution |
| 630-0016 | 5/8inches, 15.9mm | 50 | In distribution |
| 630-0015 | 1/2inches, 12.7mm | 50 | In distribution |
| 636-0128 | 3/8inches, 9.35mm | 40 | In distribution |
| 635-0067 | 1/2inches, 12.7mm | 15 | In distribution |
| 635-0062 | 1/2inches, 12.7mm | 15 | In distribution |
| 630-0043 | 3/8inches, 9.35mm | 50 | In distribution |
| 630-0037 | 3/4inches, 19.1mm | 50 | In distribution |
| 630-0013 | 5/16inches, 7.94mm | 50 | In distribution |
| 630-0040 | 3/16inches, 4.76mm | 50 | In distribution |
| 636-0117 | 3/8inches, 9.35mm | 40 | In distribution |
| 636-0116 | 5/16inches, 7.94mm | 40 | In distribution |
| 630-0051 | 1/4inches, 6.35mm | 50 | In distribution |
| 630-0033 | 5/16inches, 7.94mm | 50 | In distribution |
| 636-0114 | 3/16inches, 4.76mm | 40 | In distribution |
| 636-0126 | 1/4inches, 6.35mm | 40 | In distribution |
| 630-0034 | 3/8inches, 9.35mm | 50 | In distribution |
| 630-0031 | 3/16inches, 4.76mm | 50 | In distribution |
| 635-0065 | 5/16inches, 7.94mm | 15 | In distribution |
| 630-0023 | 3/8inches, 9.35mm | 50 | In distribution |
| 630-0010 | 1/8inches, 3.18mm | 50 | In distribution |
| 634-0003 | 3/8inches, 9.35mm | 50 | In distribution |
| 630-0052 | 5/16inches, 7.94mm | 50 | In distribution |
| 630-0032 | 1/4inches, 6.35mm | 50 | In distribution |
| 634-0014 | 1/2inches, 12.7mm | 50 | In distribution |
| 630-0053 | 3/8inches, 9.35mm | 50 | In distribution |
| 630-0036 | 5/8inches, 15.9mm | 50 | In distribution |
| 634-0000 | 3/16inches, 4.76mm | 50 | In distribution |
| 636-0115 | 1/4inches, 6.35mm | 40 | In distribution |
| 634-0001 | 1/4inches, 6.35mm | 50 | In distribution |
| 630-0042 | 5/16inches, 7.94mm | 50 | In distribution |
| 635-0066 | 3/8inches, 9.35mm | 15 | In distribution |
| 630-0011 | 3/16inches, 4.76mm | 50 | In distribution |
| 630-0030 | 1/8inches, 3.18mm | 50 | In distribution |
| 630-0050 | 3/16inches, 4.76mm | 50 | In distribution |
| 630-0022 | 5/16inches, 7.94mm | 50 | In distribution |
| 636-0122 | 1/4inches, 6.35mm | 40 | In distribution |
| 630-0020 | 3/16inches, 4.76mm | 50 | In distribution |
| 630-0021 | 1/4inches, 6.35mm | 50 | In distribution |
| 630-0012 | 1/4inches, 6.35mm | 50 | In distribution |
| 636-0125 | 3/16inches, 4.76mm | 40 | In distribution |
| 636-0127 | 5/16inches, 7.94mm | 40 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Auradonics | Auradonics Incorporated | 743 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 312 |
| Conlin Molar Band | Ortho Arch Company Inc | 308 |
| Elastic Chain | Ortho Organizers, Inc. | 248 |
| Ligatures | American Orthodontics | 233 |
| 3M™ AlastiK™ | 3M Unitek | 220 |
| Morelli | Dental Morelli Ltda. | 207 |
| Mirabay | Mirabay Orthodontics Corporation | 185 |
| Orthometric Elastomerics – Chain | Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda | 182 |
| Maximum | Ortho Technology, Inc. | 177 |
| Halo Molar Band | Ortho Arch Company Inc | 177 |
| Colored Chain | American Orthodontics | 168 |
Showing 12 of 474. All products under Band, Elastic, 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.