Tooth Tone
NiTi Coated Lower 18x18 10 archwires per pack
43manufacturers in China registered for this device type
38catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (15), Guangdong (9), Jiangsu (6). 7 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| 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 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Heilongjiang Rainbow Technology Co., Ltd. | Jiamusi | Heilongjiang | Contract manufacturer | 2 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
Showing 12 of 43. All 43 manufacturers in China registered for Wire, Orthodontic
Record
| Listed by | Ortho Technology, Inc., United States |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2019-05-02 |
| Record revised | 2024-09-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-09-16 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8000-807 | In distribution | |
| 6000-708 | In distribution | |
| 8000-907 | In distribution | |
| 6000-601 | In distribution | |
| 8000-915 | In distribution | |
| 6000-703 | In distribution | |
| 8000-904 | In distribution | |
| 8000-905 | In distribution | |
| 8000-803 | In distribution | |
| 6000-707 | In distribution | |
| 6000-702 | In distribution | |
| 8000-903 | In distribution | |
| 6000-608 | In distribution | |
| 6000-612 | In distribution | |
| 6000-607 | In distribution | |
| 8000-809 | In distribution | |
| 6000-701 | In distribution | |
| 6000-711 | In distribution | |
| 6000-704 | In distribution | |
| 6000-604 | In distribution | |
| 6000-611 | In distribution | |
| 8000-804 | In distribution | |
| 6000-603 | In distribution | |
| 6000-602 | In distribution | |
| 8000-909 | In distribution | |
| 8000-815 | In distribution | |
| 8000-802 | In distribution | |
| 8000-810 | In distribution | |
| 8000-805 | In distribution | |
| 8000-902 | In distribution | |
| 6000-712 | In distribution | |
| 6000-713 | Withdrawn | |
| 8000-910 | Withdrawn | |
| 8000-914 | Withdrawn | |
| 8000-814 | Withdrawn | |
| 8000-817 | Withdrawn | |
| 6000-613 | Withdrawn | |
| 8000-917 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wire, Orthodontic | G & H Wire Company | 2,746 |
| Europa | G & H Wire Company | 2,409 |
| Pg Supply | PG Supply, Inc. | 1,990 |
| Trueform | G & H Wire Company | 1,984 |
| G4 Nickel Titanium | G & H Wire Company | 957 |
| Tanzo | American Orthodontics | 906 |
| Aditek | Aditek DO Brasil S/A | 879 |
| G4 Europa Nickel Titanium | G & H Wire Company | 819 |
| 3M™ Unitek™ | 3M Unitek | 729 |
| Orthodontic wire | Dentos, Incorporated | 711 |
| Orthoquest | Young Innovations Inc. | 698 |
| NT3 | American Orthodontics | 694 |
Showing 12 of 679. All products under Wire, 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.