Henry Schein
Intraoral Amber Elastics 3/16" 6 OZ X-Heavy
36manufacturers in China registered for this device type
144catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2019-09-06 |
| Record revised | 2021-06-22 (version 2) |
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 |
|---|---|---|---|
| 9004900 | 1,008 | In distribution | |
| 9004902 | 1,008 | In distribution | |
| 1069915 | In distribution | ||
| 9004909 | 1,008 | In distribution | |
| 9004957 | In distribution | ||
| 9004881 | 50 | In distribution | |
| 9004951 | In distribution | ||
| 9004950 | In distribution | ||
| 9004906 | 1,008 | In distribution | |
| 9004938 | In distribution | ||
| 1062571 | 5,000 | In distribution | |
| 9007639 | 1,000 | In distribution | |
| 1067941 | 5,000 | In distribution | |
| 9004960 | In distribution | ||
| 9004933 | In distribution | ||
| 9004926 | In distribution | ||
| 9004966 | In distribution | ||
| 9004946 | In distribution | ||
| 9004948 | In distribution | ||
| 9004919 | In distribution | ||
| 9004905 | 1,008 | In distribution | |
| 9004884 | 50 | In distribution | |
| 1065614 | 100 | In distribution | |
| 1066248 | 5,000 | In distribution | |
| 9004890 | 50 | In distribution | |
| 1068253 | 5,000 | In distribution | |
| 9004925 | In distribution | ||
| 1065025 | 5,000 | In distribution | |
| 9004898 | 1,008 | In distribution | |
| 1067648 | 5,000 | In distribution | |
| 9004936 | In distribution | ||
| 9004923 | In distribution | ||
| 1066621 | 5,000 | In distribution | |
| 9004892 | 1,008 | In distribution | |
| 9004944 | In distribution | ||
| 9004955 | In distribution | ||
| 9004939 | In distribution | ||
| 9004883 | 50 | In distribution | |
| 1063394 | 100 | In distribution | |
| 1061703 | 5,000 | In distribution | |
| 1068005 | 5,000 | In distribution | |
| 9004915 | In distribution | ||
| 1062836 | 5,000 | In distribution | |
| 9004921 | In distribution | ||
| 9004968 | In distribution | ||
| 1063215 | In distribution | ||
| 9004912 | In distribution | ||
| 9004872 | 50 | In distribution | |
| 9004917 | In distribution | ||
| 9004935 | In distribution | ||
| 1061854 | In distribution | ||
| 9004886 | 50 | In distribution | |
| 9004952 | In distribution | ||
| 1067313 | 5,000 | In distribution | |
| 9004949 | In distribution | ||
| 9004913 | In distribution | ||
| 9004945 | In distribution | ||
| 1063952 | 5,000 | In distribution | |
| 9004963 | In distribution | ||
| 9004882 | 50 | In distribution | |
| 9004956 | In distribution | ||
| 9004880 | 50 | In distribution | |
| 9007638 | 1,000 | In distribution | |
| 9004903 | 1,008 | In distribution | |
| 9004932 | In distribution | ||
| 9004927 | In distribution | ||
| 1064539 | 5,000 | In distribution | |
| 9004901 | 1,008 | In distribution | |
| 1064245 | 5,000 | In distribution | |
| 9004924 | In distribution | ||
| 9004896 | 1,008 | In distribution | |
| 9004891 | 50 | In distribution | |
| 9004962 | In distribution | ||
| 9004930 | In distribution | ||
| 9004894 | 1,008 | In distribution | |
| 1067206 | 1,000 | In distribution | |
| 1062317 | 5,000 | In distribution | |
| 9004922 | In distribution | ||
| 9004889 | 50 | In distribution | |
| 9004961 | In distribution | ||
| 9004931 | In distribution | ||
| 1068206 | 5,000 | In distribution | |
| 1069302 | 5,000 | In distribution | |
| 9004918 | In distribution | ||
| 9004899 | 1,008 | In distribution | |
| 9004920 | In distribution | ||
| 9004928 | In distribution | ||
| 9004942 | In distribution | ||
| 9004878 | 50 | In distribution | |
| 9004895 | 1,008 | In distribution | |
| 1067845 | 5,000 | In distribution | |
| 9004879 | 50 | In distribution | |
| 9004907 | 1,008 | In distribution | |
| 9004893 | 1,008 | In distribution | |
| 1062223 | 5,000 | In distribution | |
| 9004941 | In distribution | ||
| 9004940 | In distribution | ||
| 9004934 | In distribution | ||
| 9004953 | In distribution | ||
| 1064453 | 5,000 | In distribution | |
| 9004877 | 50 | In distribution | |
| 1064191 | 5,000 | In distribution | |
| 1064140 | 5,000 | In distribution | |
| 9004873 | 50 | In distribution | |
| 1062231 | 5,000 | In distribution | |
| 1067568 | 5,000 | In distribution | |
| 1066243 | 5,000 | In distribution | |
| 9004964 | In distribution | ||
| 1062632 | 5,000 | In distribution | |
| 9004943 | In distribution | ||
| 9004916 | In distribution | ||
| 9004911 | 1,008 | In distribution | |
| 9004897 | 1,008 | In distribution | |
| 9004910 | 1,008 | In distribution | |
| 1067579 | 100 | In distribution | |
| 1062524 | 5,000 | In distribution | |
| 9004914 | In distribution | ||
| 9004937 | In distribution | ||
| 1061448 | In distribution | ||
| 9004967 | In distribution | ||
| 9004965 | In distribution | ||
| 9004959 | In distribution | ||
| 9004908 | 1,008 | In distribution | |
| 1062338 | In distribution | ||
| 9004874 | 50 | In distribution | |
| 9004958 | In distribution | ||
| 1062915 | 5,000 | In distribution | |
| 9004929 | In distribution | ||
| 9004954 | In distribution | ||
| 1067510 | 1,000 | In distribution | |
| 1063042 | In distribution | ||
| 9004887 | 50 | In distribution | |
| 9004875 | 50 | In distribution | |
| 9004876 | 50 | In distribution | |
| 9004885 | 50 | In distribution | |
| 1061155 | In distribution | ||
| 9004947 | In distribution | ||
| 9004904 | 1,008 | In distribution | |
| 1065013 | 5,000 | In distribution | |
| 1067186 | In distribution | ||
| 1062210 | 100 | In distribution | |
| 1068512 | 5,000 | In distribution | |
| 1062915 | 5,000 | In distribution | |
| 1060550 | 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.