The Orthodontic Store
.010 X .030 Adjustable Force Closed Coil Spring, 12Mm, Niti
22manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (4), Jiangsu (3). 3 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 |
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Guangzhou Cheer-U Material Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 15 |
| Innovative Material & Devices, Inc. | Wuxi | Jiangsu | Contract manufacturer | 13 |
Showing 12 of 22. All 22 manufacturers in China registered for Spring, Orthodontic
Record
| Listed by | Young Innovations Inc., United States |
|---|---|
| FDA product code | ECO |
| Device type | Spring, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2022-11-01 |
| Record revised | 2024-04-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Inner pack, inner pack of 10, inner pack of 3, reel |
| Distribution end date | 2024-04-13 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 428-305 | In distribution | |
| 102-13 | In distribution | |
| 102-25 | In distribution | |
| 428-200 | In distribution | |
| 102-52-7 | In distribution | |
| 102-27 | In distribution | |
| 102-52-15 | In distribution | |
| 428-105 | In distribution | |
| 102-35 | In distribution | |
| 102-18 | In distribution | |
| 428-205 | In distribution | |
| 428-800 | In distribution | |
| 615-501 | In distribution | |
| 102-51-7 | In distribution | |
| 250-100 | In distribution | |
| 102-01 | In distribution | |
| 428-300 | In distribution | |
| 102-07 | In distribution | |
| 250-200 | In distribution | |
| 102-02 | In distribution | |
| 102-03 | In distribution | |
| 102-11 | In distribution | |
| 102-26 | In distribution | |
| 428-700 | In distribution | |
| 428-550 | In distribution | |
| 615-502 | In distribution | |
| 102-05 | In distribution | |
| ECCM12 | Withdrawn | |
| 015-550 | Withdrawn | |
| ECCH9 | Withdrawn | |
| ECCH12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RMO | RMO | 57 |
| 3M™ Unitek™ | 3M Unitek | 51 |
| Aditek | Aditek DO Brasil S/A | 47 |
| OSE | Orthodontic Supply & Equipment Co., Inc. | 40 |
| 3M™ Forsus™ | 3M Unitek | 35 |
| Masel | Ortho Organizers, Inc. | 33 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 30 |
| Mico One Orthodontic Spring | ZE Fang Technology Co., Ltd. | 29 |
| NiTi Spring | American Orthodontics | 26 |
| Orthodontic Spring | Dentos, Incorporated | 25 |
| Phoenix Nickel Titanium | Phoenix Orthodontics Inc | 21 |
| Morelli | Dental Morelli Ltda. | 20 |
Showing 12 of 168. All products under Spring, 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.