Trueform Solo-Pack
Superelastic NiTi, .016x.022 (,41mm x ,56mm), Upper, Trueform I, Aesthetic, Solo-Pack
43manufacturers in China registered for this device type
343catalogue numbers in this listing
2recalls on this code
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 | G & H Wire Company, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 10 |
| Sizes | Width 0.016 to 0.025 in; height 0.016 to 0.021 in; outer diameter 0.012 to 0.02 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSTFU1818S | Width.018 in | In distribution |
| SSTFU1818AS | Height.018 in | In distribution |
| SSTFL2125AES | Height.021 in | In distribution |
| SSTFU1925AS | Height.019 in | In distribution |
| SSTFU116S | Outer Diameter.016 in | In distribution |
| TTFL016S | Outer Diameter.016 in | In distribution |
| SETFL014AS | Outer Diameter.014 in | In distribution |
| SSTFU014AES | Outer Diameter.014 in | In distribution |
| SETFL016AS | Outer Diameter.016 in | In distribution |
| TTFU3622AS | Width.022 in | In distribution |
| SSTFU3622AS | Width.022 in | In distribution |
| SSTFL018AES | Outer Diameter.018 in | In distribution |
| SETFU1925S | Height.019 in | In distribution |
| TTFU1825S | Width.025 in | In distribution |
| CUTFU1925S | Width.025 in | In distribution |
| TTFU116AS | Outer Diameter.016 in | In distribution |
| CTFL8725AS | Height.017 in | In distribution |
| SETFU1825AS | Width.025 in | In distribution |
| SETFL2125AS | Height.021 in | In distribution |
| TTFU2125S | Width.025 in | In distribution |
| SETFL012S | Outer Diameter.012 in | In distribution |
| SSTFU1717S | Height.017 in | In distribution |
| TTFL018DS | Outer Diameter.018 in | In distribution |
| SETFU012ADS | Outer Diameter.012 in | In distribution |
| SSTFU012S | Outer Diameter.012 in | In distribution |
| SSTFL3622S | Width.022 in | In distribution |
| TTFU016S | Outer Diameter.016 in | In distribution |
| SETFL1725ADS | Height.017 in | In distribution |
| SETFU1622AES | Height.016 in | In distribution |
| CTFU1616AS | Width.016 in | In distribution |
| SSTFU2125AES | Height.021 in | In distribution |
| SSTFL3622AS | Height.016 in | In distribution |
| TTFL3622S | Height.016 in | In distribution |
| CTFL1925S | Width.025 in | In distribution |
| SSTFU020GS | Outer Diameter.020 in | In distribution |
| SSTFU012AS | Outer Diameter.012 in | In distribution |
| TTFL020S | Outer Diameter.020 in | In distribution |
| SSTFL1622AS | Width.022 in | In distribution |
| SSTFU1818AES | Height.018 in | In distribution |
| CTFL8925AS | Height.019 in | In distribution |
| SETFU018S | Outer Diameter.018 in | In distribution |
| SETFL1616S | Height.016 in | In distribution |
| TTFU018AS | Outer Diameter.018 in | In distribution |
| SETFU2125S | Width.025 in | In distribution |
| SETFU016AS | Outer Diameter.016 in | In distribution |
| SSTFL016AS | Outer Diameter.016 in | In distribution |
| SETFU1825S | Height.018 in | In distribution |
| CTFL8925AS | Width.025 in | In distribution |
| TTFU2020S | Height.020 in | In distribution |
| CTFL8622S | Height.016 in | In distribution |
| TTFU018S | Outer Diameter.018 in | In distribution |
| TTFL114AS | Outer Diameter.014 in | In distribution |
| TTFU1925AS | Height.019 in | In distribution |
| SSTFU020GAS | Outer Diameter.020 in | In distribution |
| SSTFU1622AS | Height.016 in | In distribution |
| CTFU1725S | Height.017 in | In distribution |
| SETFU1622ADS | Width.022 in | In distribution |
| TTFL1825AS | Width.025 in | In distribution |
| SETFL016ADS | Outer Diameter.016 in | In distribution |
| SETFU018AS | Outer Diameter.018 in | In distribution |
| SETFU2020AS | Width.020 in | In distribution |
| TTFL020AS | Outer Diameter.020 in | In distribution |
| SSTFL1822GS | Width.022 in | In distribution |
| SSTFL1818S | Height.018 in | In distribution |
| SETFU016AS | Outer Diameter.016 in | In distribution |
| SSTFL1925AES | Width.025 in | In distribution |
| SETFL1622ADS | Height.016 in | In distribution |
| SSTFL020GS | Outer Diameter.020 in | In distribution |
| SETFL020AS | Outer Diameter.020 in | In distribution |
| SSTFL1825AES | Height.018 in | In distribution |
| TTFL018S | Outer Diameter.018 in | In distribution |
| SSTFU018S | Outer Diameter.018 in | In distribution |
| SSTFL1622GS | Width.022 in | In distribution |
| CTFL1725AS | Height.017 in | In distribution |
| SETFU012S | Outer Diameter.012 in | In distribution |
| CTFU8925AS | Width.025 in | In distribution |
| TTFL3622AS | Width.022 in | In distribution |
| TTFL116S | Outer Diameter.016 in | In distribution |
| SSTFL014AES | Outer Diameter.014 in | In distribution |
| CTFU1725AS | Width.025 in | In distribution |
| SETFU012AES | Outer Diameter.012 in | In distribution |
| TTFL016DS | Outer Diameter.016 in | In distribution |
| SSTFL020AES | Outer Diameter.020 in | In distribution |
| CTFL8925S | Height.019 in | In distribution |
| SETFU1925AS | Width.025 in | In distribution |
| SETFU016S | Outer Diameter.016 in | In distribution |
| SETFL020S | Outer Diameter.020 in | In distribution |
| SETFU2020S | Height.020 in | In distribution |
| SETFU1725DS | Width.025 in | In distribution |
| SETFL2020ADS | Width.020 in | In distribution |
| TTFU116S | Outer Diameter.016 in | In distribution |
| TTFL012AS | Outer Diameter.012 in | In distribution |
| CTFL1616S | Height.016 in | In distribution |
| CUTFU014S | Outer Diameter.014 in | In distribution |
| SSTFL1818AS | Height.018 in | In distribution |
| SETFL020AES | Outer Diameter.020 in | In distribution |
| TTFU020S | Outer Diameter.020 in | In distribution |
| SETFU020AS | Outer Diameter.020 in | In distribution |
| TTFU1818AS | Height.018 in | In distribution |
| SETFL014ADS | Outer Diameter.014 in | In distribution |
| SETFL1622AS | Width.022 in | In distribution |
| CUTFL016S | Outer Diameter.016 in | In distribution |
| TTFL016AS | Outer Diameter.016 in | In distribution |
| SETFL1825AS | Width.025 in | In distribution |
| SSTFL016AES | Outer Diameter.016 in | In distribution |
| TTFL1622S | Height.016 in | In distribution |
| TTFU2125AS | Height.021 in | In distribution |
| SETFL1725AES | Height.017 in | In distribution |
| SSTFU1725AS | Width.025 in | In distribution |
| TTFL2020S | Width.020 in | In distribution |
| CUTFU018S | Outer Diameter.018 in | In distribution |
| SSTFL1725S | Height.017 in | In distribution |
| SSTFL016S | Outer Diameter.016 in | In distribution |
| SETFL1616AS | Height.016 in | In distribution |
| SETFL014AES | Outer Diameter.014 in | In distribution |
| SETFL012ADS | Outer Diameter.012 in | In distribution |
| CUTFL012S | Outer Diameter.012 in | In distribution |
| CTFL1616AS | Height.016 in | In distribution |
| SSTFU1825S | Width.025 in | In distribution |
| SETFL014S | Outer Diameter.014 in | In distribution |
| SETFU1925AES | Width.025 in | In distribution |
| TTFU1616S | Width.016 in | In distribution |
| TTFL018ADS | Outer Diameter.018 in | In distribution |
| TTFU012S | Outer Diameter.012 in | In distribution |
| SSTFU1822AS | Height.018 in | In distribution |
| SSTFL014S | Outer Diameter.014 in | In distribution |
| SSTFU020AES | Outer Diameter.020 in | In distribution |
| SETFL1622S | Width.022 in | In distribution |
| SETFL1825DS | Height.018 in | In distribution |
| SETFU014DS | Outer Diameter.014 in | In distribution |
| TTFL012S | Outer Diameter.012 in | In distribution |
| TTFL016AS | Outer Diameter.016 in | In distribution |
| SETFU018AES | Outer Diameter.018 in | In distribution |
| SETFU1818AES | Height.018 in | In distribution |
| SSTFU1622AS | Height.016 in | In distribution |
| SSTFU018AS | Outer Diameter.018 in | In distribution |
| TTFL118AS | Outer Diameter.018 in | In distribution |
| CTFU8622AS | Height.016 in | In distribution |
| CTFU8725S | Height.017 in | In distribution |
| SSTFL1825S | Height.018 in | In distribution |
| TTFL1825S | Height.018 in | In distribution |
| SSTFL1722AS | Width.022 in | In distribution |
| SETFU016DS | Outer Diameter.016 in | In distribution |
| CUTFU012S | Outer Diameter.012 in | In distribution |
| SETFL012AES | Outer Diameter.012 in | In distribution |
| SSTFU2125AS | Height.021 in | In distribution |
| TTFL118S | Outer Diameter.018 in | In distribution |
| SETFL1825AES | Height.018 in | In distribution |
| SETFU018AS | Outer Diameter.018 in | In distribution |
| CTFL8125AS | Width.025 in | In distribution |
| SSTFU1725GAS | Height.017 in | In distribution |
| SSTFU016AS | Outer Diameter.016 in | In distribution |
| CTFU8925S | Width.025 in | In distribution |
| SSTFU1825AS | Height.018 in | In distribution |
| SETFL1622DS | Height.016 in | In distribution |
| SSTFL1725AS | Height.017 in | In distribution |
| SETFL2020AS | Width.020 in | In distribution |
| SSTFL2125AS | Width.025 in | In distribution |
| SSTFL018AS | Outer Diameter.018 in | In distribution |
| SETFL018DS | Outer Diameter.018 in | In distribution |
| SETFL1622AES | Width.022 in | In distribution |
| TTFL114S | Outer Diameter.014 in | In distribution |
| SSTFL012S | Outer Diameter.012 in | In distribution |
| SETFL014AS | Outer Diameter.014 in | In distribution |
| SSTFU1616AS | Height.016 in | In distribution |
| TTFL116AS | Outer Diameter.016 in | In distribution |
| CUTFU1825S | Height.018 in | In distribution |
| TTFU1818S | Width.018 in | In distribution |
| TTFL014AS | Outer Diameter.014 in | In distribution |
| SETFL1725AS | Height.017 in | In distribution |
| SSTFU016S | Outer Diameter.016 in | In distribution |
| TTFL1616AS | Width.016 in | In distribution |
| SETFU2020ADS | Width.020 in | In distribution |
| SSTFU1717AS | Height.017 in | In distribution |
| SETFL016AS | Outer Diameter.016 in | In distribution |
| SETFL014AS | Outer Diameter.014 in | In distribution |
| SSTFL020S | Outer Diameter.020 in | In distribution |
| SSTFU1622S | Width.022 in | In distribution |
| SSTFU014AS | Outer Diameter.014 in | In distribution |
| SSTFL1616AS | Height.016 in | In distribution |
| SETFL1925AES | Height.019 in | In distribution |
| SETFU012DS | Outer Diameter.012 in | In distribution |
| SETFU014AES | Outer Diameter.014 in | In distribution |
| SSTFU014S | Outer Diameter.014 in | In distribution |
| SSTFU3622S | Height.016 in | In distribution |
| SETFU018AS | Outer Diameter.018 in | In distribution |
| SETFL016DS | Outer Diameter.016 in | In distribution |
| CTFL8725S | Height.017 in | In distribution |
| TTFL1925AS | Width.025 in | In distribution |
| CTFU8622S | Height.016 in | In distribution |
| SSTFL1622AES | Height.016 in | In distribution |
| SETFU1725ADS | Height.017 in | In distribution |
| SETFL1825ADS | Width.025 in | In distribution |
| SETFU1818AS | Width.018 in | In distribution |
| SSTFL2125S | Width.025 in | In distribution |
| SSTFL016AS | Outer Diameter.016 in | In distribution |
| SETFL1818AES | Height.018 in | In distribution |
| CTFL8622AS | Height.016 in | In distribution |
| TTFL1616S | Height.016 in | In distribution |
| SSTFU1725S | Height.017 in | In distribution |
| TTFU2020AS | Width.020 in | In distribution |
| CTFL8825S | Height.018 in | In distribution |
| TTFL2020AS | Width.020 in | In distribution |
| SSTFU020S | Outer Diameter.020 in | In distribution |
| SETFL1825S | Width.025 in | In distribution |
| SETFU2020DS | Width.020 in | In distribution |
| SSTFL1622S | Width.022 in | In distribution |
| SETFL1622AS | Height.016 in | In distribution |
| SETFU014ADS | Outer Diameter.014 in | In distribution |
| CTFL8622AS | Height.016 in | In distribution |
| TTFL1622ADS | Width.022 in | In distribution |
| CTFL1925AS | Width.025 in | In distribution |
| CUTFU2020S | Width.020 in | In distribution |
| SETFU018ADS | Outer Diameter.018 in | In distribution |
| CTFU8825S | Height.018 in | In distribution |
| SSTFL1725AES | Height.017 in | In distribution |
| TTFL1622DS | Width.022 in | In distribution |
| TTFU1616AS | Width.016 in | In distribution |
| CTFL8622AS | Height.016 in | In distribution |
| SETFU1825AES | Height.018 in | In distribution |
| SETFU020AES | Outer Diameter.020 in | In distribution |
| TTFL016AS | Outer Diameter.016 in | In distribution |
| TTFU118AS | Outer Diameter.018 in | In distribution |
| SSTFU1616S | Height.016 in | In distribution |
| TTFU014S | Outer Diameter.014 in | In distribution |
| SSTFU1925AES | Width.025 in | In distribution |
| SETFU1725AES | Width.025 in | In distribution |
| SSTFU2125S | Height.021 in | In distribution |
| SETFU1622AS | Width.022 in | In distribution |
| SSTFU018AES | Outer Diameter.018 in | In distribution |
| TTFU016AS | Outer Diameter.016 in | In distribution |
| SSTFU1622GAS | Height.016 in | In distribution |
| TTFU020AS | Outer Diameter.020 in | In distribution |
| CTFU1616S | Height.016 in | In distribution |
| TTFU114S | Outer Diameter.014 in | In distribution |
| SETFU1622DS | Height.016 in | In distribution |
| TTFL016ADS | Outer Diameter.016 in | In distribution |
| CTFU8616S | Height.016 in | In distribution |
| CTFU8125S | Width.025 in | In distribution |
| SETFL016AS | Outer Diameter.016 in | In distribution |
| SSTFU020AS | Outer Diameter.020 in | In distribution |
| TTFL014ADS | Outer Diameter.014 in | In distribution |
| SETFL016S | Outer Diameter.016 in | In distribution |
| SSTFL2020AS | Height.020 in | In distribution |
| SETFU2125AS | Width.025 in | In distribution |
| SSTFL012AS | Outer Diameter.012 in | In distribution |
| SSTFL116S | Outer Diameter.016 in | In distribution |
| SSTFU1822S | Width.022 in | In distribution |
| CTFL8925AS | Width.025 in | In distribution |
| SETFL2125S | Height.021 in | In distribution |
Showing 250 of 300 catalogue numbers.
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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-12-13 | Class II | Employee error | Labeling issue: Product labeled as “Upper” may contain “Lower” archwires with a red midline mark. Product labeled ad “Lower” may contain “Upper” archwires with a black midline mark. | 9 packages of each lot number. | 2014-02-04 |
| 2013-12-13 | Class II | Employee error | Labeling issue: Product labeled as “Upper” may contain “Lower” archwires with a red midline mark. Product labeled ad “Lower” may contain “Upper” archwires with a black midline mark. | 37 packages | 2014-02-04 |
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.