Nitanium® BIO-Kinetix® Plus Archwires
.016 X .025 Upper Thermal Nitanium® Bio-Kinetix® Plus Pro Form™ Archwires
43manufacturers in China registered for this device type
42catalogue 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 | 2020-07-02 |
| 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, manufacturing date |
| Distribution end date | 2025-02-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 104-138 | In distribution | |
| 104-131 | In distribution | |
| 104-124 | In distribution | |
| 104-141 | In distribution | |
| 104-128 | In distribution | |
| 104-125 | In distribution | |
| 104-146 | In distribution | |
| 104-145 | In distribution | |
| 104-135 | In distribution | |
| 104-127 | In distribution | |
| 104-143 | In distribution | |
| 104-140 | In distribution | |
| 104-137 | In distribution | |
| 104-142 | In distribution | |
| 104-130 | In distribution | |
| 104-134 | In distribution | |
| 104-129 | In distribution | |
| 104-144 | In distribution | |
| 104-147 | In distribution | |
| 104-136 | In distribution | |
| 104-126 | In distribution | |
| 104-133 | In distribution | |
| 104-139 | In distribution | |
| 104-166 | Withdrawn | |
| 104-157 | Withdrawn | |
| 104-164 | Withdrawn | |
| 104-158 | Withdrawn | |
| 104-159 | Withdrawn | |
| 104-156 | Withdrawn | |
| 104-154 | Withdrawn | |
| 104-167 | Withdrawn | |
| 104-161 | Withdrawn | |
| 104-169 | Withdrawn | |
| 104-155 | Withdrawn | |
| 104-165 | Withdrawn | |
| 104-171 | Withdrawn | |
| 104-168 | Withdrawn | |
| 104-153 | Withdrawn | |
| 104-152 | Withdrawn | |
| 104-163 | Withdrawn | |
| 104-170 | Withdrawn | |
| 104-162 | 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.