Colored Chain
Elastomeric Plastic Chain 15' Closed Lavender
36manufacturers in China registered for this device type
168catalogue numbers in this listing
1510(k) clearance
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 | American Orthodontics, United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-22 |
| Record revised | 2022-10-25 (version 5) |
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 |
| Storage | Storage environment humidity 0 to 80 % RH; Special storage condition: Keep Away from Light; Storage environment temperature 2 to 38 °C |
| Distribution end date | 2022-07-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 854-402 | In distribution | |
| 854-392 | In distribution | |
| 854-353 | In distribution | |
| 854-305 | In distribution | |
| 854-407 | In distribution | |
| 854-348 | In distribution | |
| 854-289 | In distribution | |
| 854-354 | In distribution | |
| 854-303 | In distribution | |
| 854-386 | In distribution | |
| 854-408 | In distribution | |
| 854-350 | In distribution | |
| 854-292 | In distribution | |
| 854-401 | In distribution | |
| 854-213 | In distribution | |
| 854-344 | In distribution | |
| 854-029755 | In distribution | |
| 854-299 | In distribution | |
| 854-345 | In distribution | |
| 854-332 | In distribution | |
| 854-335 | In distribution | |
| 854-341 | In distribution | |
| 854-287 | In distribution | |
| 854-286 | In distribution | |
| 854-290 | In distribution | |
| 854-280 | In distribution | |
| 854-334 | In distribution | |
| 854-351 | In distribution | |
| 854-310 | In distribution | |
| 854-288 | In distribution | |
| 854-398 | In distribution | |
| 854-333 | In distribution | |
| 854-235 | In distribution | |
| 854-231 | In distribution | |
| 854-211 | In distribution | |
| 854-296 | In distribution | |
| 854-342 | In distribution | |
| 854-411 | In distribution | |
| 854-396 | In distribution | |
| 854-404 | In distribution | |
| 854-340 | In distribution | |
| 854-295 | In distribution | |
| 854-394 | In distribution | |
| 854-405 | In distribution | |
| 854-390 | In distribution | |
| 854-293 | In distribution | |
| 854-382 | In distribution | |
| 854-306 | In distribution | |
| 854-029759 | In distribution | |
| 854-302 | In distribution | |
| 854-309 | In distribution | |
| 854-282 | In distribution | |
| 854-285 | In distribution | |
| 854-283 | In distribution | |
| 854-284 | In distribution | |
| 854-297 | In distribution | |
| 854-400 | In distribution | |
| 854-409 | In distribution | |
| 854-210 | In distribution | |
| 854-336 | In distribution | |
| 854-347 | In distribution | |
| 854-406 | In distribution | |
| 854-337 | In distribution | |
| 854-410 | In distribution | |
| 854-298 | In distribution | |
| 854-343 | In distribution | |
| 854-338 | In distribution | |
| 854-294 | In distribution | |
| 854-352 | In distribution | |
| 854-388 | In distribution | |
| 854-281 | In distribution | |
| 854-331 | In distribution | |
| 854-301 | In distribution | |
| 854-403 | In distribution | |
| 854-399 | In distribution | |
| 854-304 | In distribution | |
| 854-384 | In distribution | |
| 854-349 | In distribution | |
| 854-346 | In distribution | |
| 854-212 | In distribution | |
| 854-330 | In distribution | |
| 854-308 | In distribution | |
| 854-291 | In distribution | |
| 854-029757 | In distribution | |
| 854-344 | Withdrawn | |
| 854-290 | Withdrawn | |
| 854-341 | Withdrawn | |
| 854-294 | Withdrawn | |
| 854-336 | Withdrawn | |
| 854-386 | Withdrawn | |
| 854-235 | Withdrawn | |
| 854-304 | Withdrawn | |
| 854-399 | Withdrawn | |
| 854-280 | Withdrawn | |
| 854-351 | Withdrawn | |
| 854-343 | Withdrawn | |
| 854-409 | Withdrawn | |
| 854-388 | Withdrawn | |
| 854-350 | Withdrawn | |
| 854-313 | Withdrawn | |
| 854-284 | Withdrawn | |
| 854-392 | Withdrawn | |
| 854-233 | Withdrawn | |
| 854-406 | Withdrawn | |
| 854-334 | Withdrawn | |
| 854-234 | Withdrawn | |
| 854-348 | Withdrawn | |
| 854-283 | Withdrawn | |
| 854-282 | Withdrawn | |
| 854-289 | Withdrawn | |
| 854-411 | Withdrawn | |
| 854-288 | Withdrawn | |
| 854-295 | Withdrawn | |
| 854-394 | Withdrawn | |
| 854-404 | Withdrawn | |
| 854-401 | Withdrawn | |
| 854-298 | Withdrawn | |
| 854-213 | Withdrawn | |
| 854-292 | Withdrawn | |
| 854-354 | Withdrawn | |
| 854-286 | Withdrawn | |
| 854-211 | Withdrawn | |
| 854-231 | Withdrawn | |
| 854-281 | Withdrawn | |
| 854-340 | Withdrawn | |
| 854-349 | Withdrawn | |
| 854-398 | Withdrawn | |
| 854-400 | Withdrawn | |
| 854-342 | Withdrawn | |
| 854-384 | Withdrawn | |
| 854-287 | Withdrawn | |
| 854-330 | Withdrawn | |
| 854-337 | Withdrawn | |
| 854-403 | Withdrawn | |
| 854-285 | Withdrawn | |
| 854-396 | Withdrawn | |
| 854-408 | Withdrawn | |
| 854-210 | Withdrawn | |
| 854-407 | Withdrawn | |
| 854-338 | Withdrawn | |
| 854-311 | Withdrawn | |
| 854-299 | Withdrawn | |
| 854-303 | Withdrawn | |
| 854-345 | Withdrawn | |
| 854-296 | Withdrawn | |
| 854-302 | Withdrawn | |
| 854-291 | Withdrawn | |
| 854-353 | Withdrawn | |
| 854-346 | Withdrawn | |
| 854-232 | Withdrawn | |
| 854-293 | Withdrawn | |
| 854-306 | Withdrawn | |
| 854-297 | Withdrawn | |
| 854-347 | Withdrawn | |
| 854-410 | Withdrawn | |
| 854-312 | Withdrawn | |
| 854-305 | Withdrawn | |
| 854-301 | Withdrawn | |
| 854-405 | Withdrawn | |
| 854-402 | Withdrawn | |
| 854-382 | Withdrawn | |
| 854-390 | Withdrawn | |
| 854-212 | Withdrawn | |
| 854-331 | Withdrawn | |
| 854-352 | Withdrawn | |
| 854-332 | Withdrawn | |
| 854-333 | Withdrawn | |
| 854-335 | Withdrawn |
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 |
| The Orthodontic Store | Young Innovations Inc. | 155 |
Showing 12 of 474. All products under Band, Elastic, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K926578 | 1993-03-31 |
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.