PRO-Elast
Elastomerics Tuff-Ligature Thread 0.030 ” 25 ft / spool Clear
36manufacturers in China registered for this device type
48catalogue 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 | Ortho Pro Dent LLC, United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2024-11-04 |
| Record revised | 2024-11-05 (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, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ELN-4516 | In distribution | |
| EL-0638 | In distribution | |
| EL-0614 | In distribution | |
| ELN-4514 | In distribution | |
| ELLT-G30 | In distribution | |
| EL-4518 | In distribution | |
| ELLT-C30 | In distribution | |
| EL-25516 | In distribution | |
| ELN-2538 | In distribution | |
| ELN-3516 | In distribution | |
| EL-3514 | In distribution | |
| ELN-2514 | In distribution | |
| ELN-2518 | In distribution | |
| ELRG-700 | In distribution | |
| EL-2518 | In distribution | |
| ELN-45516 | In distribution | |
| ELN-3514 | In distribution | |
| ELN-3518 | In distribution | |
| EL-4538 | In distribution | |
| ELRC-700 | In distribution | |
| ELN-25516 | In distribution | |
| EL-3516 | In distribution | |
| EL-3518 | In distribution | |
| ELN-0616 | In distribution | |
| EL-45516 | In distribution | |
| ELN-4518 | In distribution | |
| EL-2516 | In distribution | |
| ELS-1000 | In distribution | |
| ELN-3538 | In distribution | |
| ELN-4538 | In distribution | |
| EL-3538 | In distribution | |
| ELN-0618 | In distribution | |
| EL-2538 | In distribution | |
| ELLT-G25 | In distribution | |
| EL-0616 | In distribution | |
| ELN-0614 | In distribution | |
| ELN-35516 | In distribution | |
| EL-4514 | In distribution | |
| ELN-0638 | In distribution | |
| ELLT-C25 | In distribution | |
| ELN-06516 | In distribution | |
| EL-0618 | In distribution | |
| EL-35516 | In distribution | |
| EL-06516 | In distribution | |
| EL-2514 | In distribution | |
| EL-4516 | In distribution | |
| ELN-2518 | In distribution | |
| ELN-2516 | 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.