Ortho Organizers
Vertical Slot Rotation Springs Medium Counter-Clockwise
22manufacturers in China registered for this device type
19catalogue 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 | Ortho Organizers, 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-09-08 |
| Record revised | 2025-12-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2025-02-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100-644 | In distribution | |
| 100-647 | In distribution | |
| 105-020 | In distribution | |
| 100-623 | In distribution | |
| 100-622 | In distribution | |
| 100-642 | In distribution | |
| 100-636 | In distribution | |
| 100-638 | In distribution | |
| 100-637 | In distribution | |
| 100-691 | In distribution | |
| 100-643 | In distribution | |
| 100-690 | In distribution | |
| 100-639 | Withdrawn | |
| 105-044 | Withdrawn | |
| 105-045 | Withdrawn | |
| 105-025 | Withdrawn | |
| 105-041 | Withdrawn | |
| 105-064 | Withdrawn | |
| 105-040 | 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 |
| The Orthodontic Store | Young Innovations Inc. | 31 |
| 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 |
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.