Phoenix Elastics
NON LATEX AMBER 1-4 MEDIUM 4.5 OUNCE ELASTICS (2) 50 PK=100 Patient Packs
36manufacturers in China registered for this device type
64catalogue 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 | Phoenix Orthodontics Inc, 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 | 2020-08-17 |
| Record revised | 2024-08-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 6 to 25 °C |
| Distribution end date | 2024-09-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| E-450-NGC | 100 | Withdrawn | |
| E-NLMC-38 | 100 | Withdrawn | |
| E-450-ORE | 100 | Withdrawn | |
| E-NLLC-38 | 100 | Withdrawn | |
| E-450-NORE | 100 | Withdrawn | |
| E-450-ORC | 100 | Withdrawn | |
| E-450-NBE | 100 | Withdrawn | |
| E-NLMC-516 | 100 | Withdrawn | |
| E-NLH-516 | 100 | Withdrawn | |
| E-450-ORB | 100 | Withdrawn | |
| E-450-NBB | 100 | Withdrawn | |
| E-450-PD | 100 | Withdrawn | |
| E-NLH-38 | 100 | Withdrawn | |
| E-450-BA | 100 | Withdrawn | |
| E-450-NBD | 100 | Withdrawn | |
| E-NLL-38 | 100 | Withdrawn | |
| E-NLL-18 | 100 | Withdrawn | |
| E-NLH-316 | 100 | Withdrawn | |
| E-450-NORB | 100 | Withdrawn | |
| E-NLM-14 | 100 | Withdrawn | |
| E-450-GE | 100 | Withdrawn | |
| E-450-ORD | 100 | Withdrawn | |
| E-NLM-18 | 100 | Withdrawn | |
| E-NLH-18 | 100 | Withdrawn | |
| E-NLMC-316 | 100 | Withdrawn | |
| E-450-NORD | 100 | Withdrawn | |
| E-450-GA | 100 | Withdrawn | |
| E-450-GB | 100 | Withdrawn | |
| E-450-NPB | 100 | Withdrawn | |
| E-NLHC-38 | 100 | Withdrawn | |
| E-NLM-38 | 100 | Withdrawn | |
| E-450-NBA | 100 | Withdrawn | |
| E-NLLC-316 | 100 | Withdrawn | |
| E-450-NBC | 100 | Withdrawn | |
| E-450-NGE | 100 | Withdrawn | |
| E-450-BD | 100 | Withdrawn | |
| E-450-NGB | 100 | Withdrawn | |
| E-450-BE | 100 | Withdrawn | |
| E-450-BB | 100 | Withdrawn | |
| E-450-BC | 100 | Withdrawn | |
| E-NLLC-516 | 100 | Withdrawn | |
| E-NLHC-14 | 100 | Withdrawn | |
| E-NLLC-14 | 100 | Withdrawn | |
| E-450-GC | 100 | Withdrawn | |
| E-450-PB | 100 | Withdrawn | |
| E-NLHC-18 | 100 | Withdrawn | |
| E-450-NORC | 100 | Withdrawn | |
| E-450-NORA | 100 | Withdrawn | |
| E-NLLC-18 | 100 | Withdrawn | |
| E-NLMC-14 | 100 | Withdrawn | |
| E-NLMC-18 | 100 | Withdrawn | |
| E-NLHC-516 | 100 | Withdrawn | |
| E-NLHC-316 | 100 | Withdrawn | |
| E-NLH-14 | 100 | Withdrawn | |
| E-NLL-316 | 100 | Withdrawn | |
| E-450-PC | 100 | Withdrawn | |
| E-450-GD | 100 | Withdrawn | |
| E-450-NGA | 100 | Withdrawn | |
| E-NLM-516 | 100 | Withdrawn | |
| E-450-NGD | 100 | Withdrawn | |
| E-NLL-516 | 100 | Withdrawn | |
| E-NLL-14 | 100 | Withdrawn | |
| E-NLM-316 | 100 | Withdrawn | |
| E-450-ORA | 100 | 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 |
| 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.