Ormco
Spring Coil Close Wound PKG 009 X 030
22manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
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 | Ormco Corporation, United States |
|---|---|
| FDA product code | ECO |
| Device type | Spring, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 221-5510 | 010 X 030 inches | 3 | In distribution |
| 222-0930 | 009 X 030 inches | In distribution | |
| 221-0901 | 009 X 060 inches | 3 | In distribution |
| 221-1150 | 0115 X 060 inches | 3 | In distribution |
| 704-6021 | 009 X 030 inches | 50 | In distribution |
| 221-5512 | 012 X 030 inches | 3 | In distribution |
| 221-0930 | 009 X 030 inches | In distribution | |
| 222-5610 | 10 | In distribution | |
| 221-1001 | 010 x 060 inches | 3 | In distribution |
| 222-1001 | 010 X 060 inches | 3 | In distribution |
| 222-5612 | 10 | In distribution | |
| 222-5620 | 10 | In distribution | |
| 704-6022 | 011 X 030 inches | 50 | In distribution |
| 222-0901 | 009 X 060 inches | 3 | In distribution |
| 221-1030 | 010 X 030 inches | In distribution | |
| 221-0830 | 008 X 030 inches | In distribution | |
| 222-0830 | 008 X 030 inches | In distribution | |
| 221-5514 | 014 X 036 inches | 3 | In distribution |
| 222-1030 | 010 X 030 inches | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K943068 | 1994-08-17 |
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.