BIO-Kinetix® Thermal Nitanium®archwires
.018 X .025 Lower Bio-Kinetix® Thermal Nitanium® ProForm™ Archwires with Dimple
43manufacturers in China registered for this device type
46catalogue 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 Organizers, Inc., United States |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-30 |
| Record revised | 2025-12-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100-852 | In distribution | |
| 100-867DM | In distribution | |
| 100-873DM | In distribution | |
| 101-463 | In distribution | |
| 101-474 | In distribution | |
| 101-473 | In distribution | |
| 101-480 | In distribution | |
| 100-853 | In distribution | |
| 101-471 | In distribution | |
| 100-874DM | In distribution | |
| 101-464 | In distribution | |
| 100-854 | In distribution | |
| 101-466 | In distribution | |
| 100-866 | In distribution | |
| 100-870 | In distribution | |
| 101-472 | In distribution | |
| 100-851 | In distribution | |
| 100-866DM | In distribution | |
| 100-863 | In distribution | |
| 100-872DM | In distribution | |
| 100-867 | In distribution | |
| 100-857 | In distribution | |
| 100-855 | In distribution | |
| 100-860 | In distribution | |
| 100-852DM | In distribution | |
| 101-481 | In distribution | |
| 100-865 | In distribution | |
| 100-869 | In distribution | |
| 100-854DM | In distribution | |
| 100-862 | In distribution | |
| 100-856DM | In distribution | |
| 100-856 | In distribution | |
| 100-871 | In distribution | |
| 100-853DM | In distribution | |
| 100-850 | In distribution | |
| 100-864 | In distribution | |
| 100-857DM | In distribution | |
| 100-861 | In distribution | |
| 101-465 | In distribution | |
| 100-855DM | In distribution | |
| 101-475 | In distribution | |
| 101-462 | In distribution | |
| 100-868 | In distribution | |
| 100-875DM | In distribution | |
| 101-470 | In distribution | |
| 101-467 | In distribution |
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.