RMO
ENERGY THREAD SQUARE .018" x .018" CLEAR 25FT
36manufacturers in China registered for this device type
118catalogue 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 | RMO, United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| J00272 | In distribution | ||
| I00810 | In distribution | ||
| J00168 | In distribution | ||
| J01183 | 1,000 | In distribution | |
| J00261 | In distribution | ||
| J00342 | In distribution | ||
| J00340 | In distribution | ||
| J00192 | In distribution | ||
| J01131 | 500 | In distribution | |
| J01451 | 1,000 | In distribution | |
| J00193 | In distribution | ||
| J00141 | In distribution | ||
| J00359 | In distribution | ||
| J00269 | In distribution | ||
| J01124 | 500 | In distribution | |
| J00353 | In distribution | ||
| J00195 | In distribution | ||
| J00267 | In distribution | ||
| J00357 | In distribution | ||
| J00223 | In distribution | ||
| J00355 | In distribution | ||
| J00235 | In distribution | ||
| J01142 | 500 | In distribution | |
| A04159 | 500 | In distribution | |
| M02373 | In distribution | ||
| J00360 | In distribution | ||
| J00224 | In distribution | ||
| J00138 | In distribution | ||
| J01132 | 500 | In distribution | |
| J00146 | In distribution | ||
| J01181 | 1,000 | In distribution | |
| J00239 | In distribution | ||
| J01114 | 500 | In distribution | |
| J00277 | In distribution | ||
| J00167 | In distribution | ||
| J00145 | In distribution | ||
| J01185 | 500 | In distribution | |
| J00278 | In distribution | ||
| J01123 | 500 | In distribution | |
| M02335 | In distribution | ||
| J01133 | 500 | In distribution | |
| J00180 | In distribution | ||
| J00264 | In distribution | ||
| J00344 | In distribution | ||
| J01450 | 1,000 | In distribution | |
| J00364 | In distribution | ||
| J00236 | In distribution | ||
| A00788 | In distribution | ||
| J00350 | In distribution | ||
| J00231 | In distribution | ||
| J00122 | In distribution | ||
| J00352 | In distribution | ||
| J00273 | In distribution | ||
| J00278 | In distribution | ||
| J01120 | 500 | In distribution | |
| J01101 | 500 | In distribution | |
| J00181 | In distribution | ||
| J01140 | 500 | In distribution | |
| J00144 | In distribution | ||
| J00341 | In distribution | ||
| J00275 | In distribution | ||
| J00136 | In distribution | ||
| J00262 | In distribution | ||
| J01143 | 500 | In distribution | |
| J00346 | In distribution | ||
| J00142 | In distribution | ||
| J01184 | 1,000 | In distribution | |
| J01103 | 500 | In distribution | |
| M02349 | 1,000 | In distribution | |
| J01112 | 500 | In distribution | |
| J00268 | In distribution | ||
| J00137 | In distribution | ||
| J00343 | In distribution | ||
| J00279 | In distribution | ||
| J00140 | In distribution | ||
| J01104 | 500 | In distribution | |
| J01144 | 500 | In distribution | |
| J00120 | In distribution | ||
| J00354 | In distribution | ||
| A07121 | In distribution | ||
| J00270 | In distribution | ||
| J00271 | In distribution | ||
| J00266 | In distribution | ||
| J01100 | 500 | In distribution | |
| J00337 | In distribution | ||
| J01111 | 500 | In distribution | |
| J00361 | In distribution | ||
| J00122 | In distribution | ||
| J00348 | In distribution | ||
| J00143 | In distribution | ||
| J01113 | 500 | In distribution | |
| J00356 | In distribution | ||
| J00177 | In distribution | ||
| J01102 | 500 | In distribution | |
| J00349 | In distribution | ||
| J00196 | In distribution | ||
| J01182 | 1,000 | In distribution | |
| J00121 | In distribution | ||
| J00240 | In distribution | ||
| J01141 | 500 | In distribution | |
| J00139 | In distribution | ||
| J00351 | In distribution | ||
| J00194 | In distribution | ||
| J00158 | 600 | In distribution | |
| J00191 | In distribution | ||
| J00347 | In distribution | ||
| J01174 | 1,000 | In distribution | |
| J00147 | In distribution | ||
| J00358 | In distribution | ||
| J00263 | In distribution | ||
| J00265 | In distribution | ||
| J00232 | In distribution | ||
| J00227 | In distribution | ||
| J00274 | In distribution | ||
| J00345 | In distribution | ||
| J00228 | In distribution | ||
| J01122 | 500 | In distribution | |
| J01121 | 500 | 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.