Tru-Chrome
TRU-Chrome Preformed Expanded Arch MX/MN 019X025
43manufacturers in China registered for this device type
123catalogue 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 | RMO, United States |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-20 |
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 |
|---|---|---|---|
| E07040 | 10 | In distribution | |
| E00128 | In distribution | ||
| A00781 | 100 | In distribution | |
| E00016 | 10 | In distribution | |
| A07226 | 10 | In distribution | |
| E07041 | 10 | In distribution | |
| A0078 | 100 | In distribution | |
| E00120 | In distribution | ||
| A00824 | 10 | In distribution | |
| E00063 | 5 | In distribution | |
| A07201 | 100 | In distribution | |
| A07253 | 100 | In distribution | |
| A07272 | 100 | In distribution | |
| E01400 | 10 | In distribution | |
| A07203 | 100 | In distribution | |
| A00808 | 10 | In distribution | |
| A07207-1 | 10 | In distribution | |
| A07207 | 10 | In distribution | |
| E00022 | 5 | In distribution | |
| A07252 | 100 | In distribution | |
| E01403 | 10 | In distribution | |
| A00787 | 100 | In distribution | |
| A07662 | 100 | In distribution | |
| E00010 | 10 | In distribution | |
| A01433 | 10 | In distribution | |
| A07276 | 10 | In distribution | |
| E00019 | 10 | In distribution | |
| A07261 | 10 | In distribution | |
| A07260 | 10 | In distribution | |
| A00803 | 10 | In distribution | |
| A07251 | 100 | In distribution | |
| E00015 | 10 | In distribution | |
| A00813 | 10 | In distribution | |
| A07223 | 100 | In distribution | |
| A07227 | 10 | In distribution | |
| A07210 | 10 | In distribution | |
| A00783 | 100 | In distribution | |
| A07280 | 10 | In distribution | |
| A07227-1 | 10 | In distribution | |
| A00801 | 10 | In distribution | |
| E00177 | 10 | In distribution | |
| A07206 | 10 | In distribution | |
| E00021 | 6 | In distribution | |
| E00024 | 5 | In distribution | |
| A00788 | 100 | In distribution | |
| E00009 | 30 | In distribution | |
| E00126 | In distribution | ||
| A07255 | 10 | In distribution | |
| A07208-1 | 10 | In distribution | |
| A00782 | 100 | In distribution | |
| E00098 | 10 | In distribution | |
| E00122 | In distribution | ||
| A07271 | 100 | In distribution | |
| E01405 | 10 | In distribution | |
| E00005 | 30 | In distribution | |
| A07275 | 10 | In distribution | |
| E00182 | 10 | In distribution | |
| A07209 | 10 | In distribution | |
| A07202 | 100 | In distribution | |
| A00798 | 10 | In distribution | |
| A07212 | 10 | In distribution | |
| A00800 | 10 | In distribution | |
| A07221 | 100 | In distribution | |
| E00314 | 10 | In distribution | |
| A07225 | 10 | In distribution | |
| E00018 | 10 | In distribution | |
| E00062 | 5 | In distribution | |
| A00810 | 10 | In distribution | |
| A07667 | 10 | In distribution | |
| E00311 | 10 | In distribution | |
| A07208 | 10 | In distribution | |
| A07258 | 10 | In distribution | |
| E00090 | 10 | In distribution | |
| E00099 | 10 | In distribution | |
| A07277 | 10 | In distribution | |
| E00020 | 6 | In distribution | |
| A07232 | 10 | In distribution | |
| A07279 | 10 | In distribution | |
| A07229 | 10 | In distribution | |
| E00117 | 20 | In distribution | |
| A07273 | 100 | In distribution | |
| E00181 | 10 | In distribution | |
| E01401 | 10 | In distribution | |
| A07257 | 10 | In distribution | |
| E00097 | 10 | In distribution | |
| E00134 | In distribution | ||
| E00096 | 10 | In distribution | |
| A07228 | 10 | In distribution | |
| E00121 | In distribution | ||
| E00084 | 6 | In distribution | |
| A07230 | 10 | In distribution | |
| E00013 | 20 | In distribution | |
| A07222 | 100 | In distribution | |
| E00082 | 10 | In distribution | |
| A07205 | 10 | In distribution | |
| E00080 | 10 | In distribution | |
| E00017 | 10 | In distribution | |
| A07228-1 | 10 | In distribution | |
| A07231 | 10 | In distribution | |
| A07281 | 10 | In distribution | |
| E00123 | In distribution | ||
| A00819 | 10 | In distribution | |
| A07259 | 10 | In distribution | |
| E00129 | In distribution | ||
| A07211 | 10 | In distribution | |
| A00802 | 10 | In distribution | |
| E00081 | 10 | In distribution | |
| E00095 | 10 | In distribution | |
| E01404 | 10 | In distribution | |
| E00133 | In distribution | ||
| A00811 | 10 | In distribution | |
| E00125 | In distribution | ||
| A04159 | 10 | In distribution | |
| A07278 | 10 | In distribution | |
| E00313 | 10 | In distribution | |
| E00083 | 10 | In distribution | |
| E00007 | 30 | In distribution | |
| A00812 | 10 | In distribution | |
| E00130 | In distribution | ||
| E00178 | 10 | In distribution | |
| E00175 | 10 | In distribution | |
| E00176 | 10 | In distribution | |
| E00011 | 10 | 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.