G4 Trueform Nickel Titanium Solo-Pack
G4 NiTi, .021x.025 (,53mm x ,64mm), Lower, Trueform I, Aesthetic, Solo-Pack
43manufacturers in China registered for this device type
276catalogue 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 | 2025-03-26 |
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 0.014 to 0.021 in; outer diameter 0.012 to 0.02 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G4TFU118AS | Outer Diameter.018 in | In distribution |
| G4TFU3622ADS | Width.022 in | In distribution |
| G4TFL1725ACS | Width.025 in | In distribution |
| G4TFM018CS | Outer Diameter.018 in | In distribution |
| G4TFU2020ADS | Height.020 in | In distribution |
| G4TFU1725CS | Height.017 in | In distribution |
| G4TFL1725AS | Height.017 in | In distribution |
| G4TFL2125AES | Height.021 in | In distribution |
| G4TFL018S | Outer Diameter.018 in | In distribution |
| G4TFU1425AS | Width.025 in | In distribution |
| G4TFL020AES | Outer Diameter.020 in | In distribution |
| G4TFU118S | Outer Diameter.018 in | In distribution |
| G4TFL016AS | Outer Diameter.016 in | In distribution |
| G4TFU1925AS | Width.025 in | In distribution |
| G4TFU020ADS | Outer Diameter.020 in | In distribution |
| G4TFU018AS | Outer Diameter.018 in | In distribution |
| PTTF192534S | Width.025 in | In distribution |
| G4TFU1425CS | Width.025 in | In distribution |
| G4TFU1425S | Height.014 in | In distribution |
| G4TFL014CS | Outer Diameter.014 in | In distribution |
| G4TFL3622ADS | Width.022 in | In distribution |
| G4TFU1616DS | Width.016 in | In distribution |
| G4TFL014AES | Outer Diameter.014 in | In distribution |
| G4TFU1825AS | Height.018 in | In distribution |
| G4TFU014DS | Outer Diameter.014 in | In distribution |
| PTTF192534ACS | Width.025 in | In distribution |
| G4TFM1925S | Width.025 in | In distribution |
| G4TFL1622CS | Height.016 in | In distribution |
| G4TFL1825AS | Height.018 in | In distribution |
| G4TFL1825S | Width.025 in | In distribution |
| G4TFU016ADS | Outer Diameter.016 in | In distribution |
| G4TFL2125AS | Height.021 in | In distribution |
| G4TFU020AES | Outer Diameter.020 in | In distribution |
| G4TFU114S | Outer Diameter.014 in | In distribution |
| G4TFL2020ACS | Height.020 in | In distribution |
| G4TFL1616AS | Width.016 in | In distribution |
| G4TFL012S | Outer Diameter.012 in | In distribution |
| G4TFL1622AES | Height.016 in | In distribution |
| G4TFL016DS | Outer Diameter.016 in | In distribution |
| G4TFL2020CS | Height.020 in | In distribution |
| G4TFU016AS | Outer Diameter.016 in | In distribution |
| G4TFU018ADS | Outer Diameter.018 in | In distribution |
| PTTF212528S | Height.021 in | In distribution |
| G4TFL1925ACS | Width.025 in | In distribution |
| G4TFL020ADS | Outer Diameter.020 in | In distribution |
| G4TFU1622AS | Width.022 in | In distribution |
| G4TFL2125S | Height.021 in | In distribution |
| G4TFL112AS | Outer Diameter.012 in | In distribution |
| G4TFL012AES | Outer Diameter.012 in | In distribution |
| G4TFU020ACS | Outer Diameter.020 in | In distribution |
| G4TFL014ACS | Outer Diameter.014 in | In distribution |
| G4TFL1925AS | Height.019 in | In distribution |
| G4TFL1818S | Height.018 in | In distribution |
| PTTF192528AS | Width.025 in | In distribution |
| G4TFU016AS | Outer Diameter.016 in | In distribution |
| PTTF172534CS | Width.025 in | In distribution |
| G4TFM018ACS | Outer Diameter.018 in | In distribution |
| G4TFU1616S | Width.016 in | In distribution |
| G4TFL2020ADS | Width.020 in | In distribution |
| G4TFU1925AS | Height.019 in | In distribution |
| PTTF212534S | Width.025 in | In distribution |
| G4TFU1925AS | Width.025 in | In distribution |
| G4TFU012DS | Outer Diameter.012 in | In distribution |
| G4TFM1825CS | Width.025 in | In distribution |
| G4TFU018S | Outer Diameter.018 in | In distribution |
| G4TFU1616ADS | Height.016 in | In distribution |
| G4TFL020ACS | Outer Diameter.020 in | In distribution |
| PTTF172528CS | Width.025 in | In distribution |
| PTTF192534AS | Width.025 in | In distribution |
| G4TFU1825DS | Height.018 in | In distribution |
| G4TFU1825CS | Width.025 in | In distribution |
| G4TFS1825ACS | Width.025 in | In distribution |
| G4TFL1818AES | Height.018 in | In distribution |
| PTTF172534ACS | Width.025 in | In distribution |
| G4TFU018DS | Outer Diameter.018 in | In distribution |
| G4TFU1725AS | Width.025 in | In distribution |
| G4TFM016S | Outer Diameter.016 in | In distribution |
| G4TFM014S | Outer Diameter.014 in | In distribution |
| PTTF172528AS | Width.025 in | In distribution |
| G4TFL016ADS | Outer Diameter.016 in | In distribution |
| G4TFL118AS | Outer Diameter.018 in | In distribution |
| G4TFU2125AES | Width.025 in | In distribution |
| G4TFU112AS | Outer Diameter.012 in | In distribution |
| G4TFL1818DS | Height.018 in | In distribution |
| G4TFU014AS | Outer Diameter.014 in | In distribution |
| G4TFL1725AES | Width.025 in | In distribution |
| G4TFU1622CS | Height.016 in | In distribution |
| G4TFU014AS | Outer Diameter.014 in | In distribution |
| G4TFL1622DS | Width.022 in | In distribution |
| G4TFU2020DS | Width.020 in | In distribution |
| G4TFL018DS | Outer Diameter.018 in | In distribution |
| G4TFL1725AS | Width.025 in | In distribution |
| G4TFU1717ADS | Height.017 in | In distribution |
| G4TFL120AS | Outer Diameter.020 in | In distribution |
| G4TFL1725S | Height.017 in | In distribution |
| G4TFU1725S | Height.017 in | In distribution |
| G4TFM1425CS | Height.014 in | In distribution |
| PTTF172538ACS | Width.025 in | In distribution |
| G4TFL020AS | Outer Diameter.020 in | In distribution |
| G4TFL1622ACS | Width.022 in | In distribution |
| G4TFU1825ADS | Height.018 in | In distribution |
| G4TFU012ADS | Outer Diameter.012 in | In distribution |
| PTTF172538CS | Width.025 in | In distribution |
| PTTF192538S | Width.025 in | In distribution |
| G4TFL1616ADS | Height.016 in | In distribution |
| G4TFL012DS | Outer Diameter.012 in | In distribution |
| G4TFU120S | Outer Diameter.020 in | In distribution |
| G4TFU012S | Outer Diameter.012 in | In distribution |
| G4TFU014ADS | Outer Diameter.014 in | In distribution |
| G4TFU1616CS | Height.016 in | In distribution |
| G4TFU1925CS | Height.019 in | In distribution |
| G4TFL018ACS | Outer Diameter.018 in | In distribution |
| PTTF212538AS | Width.025 in | In distribution |
| PTTF172538S | Height.017 in | In distribution |
| G4TFU1622ACS | Height.016 in | In distribution |
| G4TFU016AES | Outer Diameter.016 in | In distribution |
| G4TFL014AS | Outer Diameter.014 in | In distribution |
| G4TFL1925ADS | Height.019 in | In distribution |
| G4TFU3725S | Height.017 in | In distribution |
| G4TFU020DS | Outer Diameter.020 in | In distribution |
| G4TFL1725ADS | Width.025 in | In distribution |
| G4TFL018AS | Outer Diameter.018 in | In distribution |
| G4TFL1825CS | Width.025 in | In distribution |
| G4TFL1818CS | Height.018 in | In distribution |
| G4TFU1925S | Height.019 in | In distribution |
| G4TFU012AES | Outer Diameter.012 in | In distribution |
| G4TFU3622S | Height.016 in | In distribution |
| G4TFL114AS | Outer Diameter.014 in | In distribution |
| G4TFU1725ADS | Height.017 in | In distribution |
| G4TFL018AS | Outer Diameter.018 in | In distribution |
| G4TFU1825AES | Height.018 in | In distribution |
| PTTF212538S | Height.021 in | In distribution |
| G4TFL114S | Outer Diameter.014 in | In distribution |
| G4TFL3725AS | Width.025 in | In distribution |
| G4TFU020AS | Outer Diameter.020 in | In distribution |
| G4TFU2125S | Width.025 in | In distribution |
| G4TFU014AES | Outer Diameter.014 in | In distribution |
| G4TFU1622AS | Height.016 in | In distribution |
| G4TFL1622S | Width.022 in | In distribution |
| G4TFL2020S | Height.020 in | In distribution |
| G4TFL2020AS | Height.020 in | In distribution |
| G4TFL116S | Outer Diameter.016 in | In distribution |
| G4TFU018AES | Outer Diameter.018 in | In distribution |
| G4TFU016DS | Outer Diameter.016 in | In distribution |
| G4TFU1818AS | Width.018 in | In distribution |
| G4TFL2020DS | Width.020 in | In distribution |
| G4TFL016AS | Outer Diameter.016 in | In distribution |
| G4TFU014CS | Outer Diameter.014 in | In distribution |
| G4TFL1622ADS | Height.016 in | In distribution |
| G4TFL018CS | Outer Diameter.018 in | In distribution |
| G4TFL120S | Outer Diameter.020 in | In distribution |
| G4TFL020S | Outer Diameter.020 in | In distribution |
| G4TFU018AS | Outer Diameter.018 in | In distribution |
| G4TFS018ACS | Outer Diameter.018 in | In distribution |
| G4TFL1818ADS | Height.018 in | In distribution |
| G4TFL020CS | Outer Diameter.020 in | In distribution |
| G4TFU1616AES | Height.016 in | In distribution |
| G4TFL012AS | Outer Diameter.012 in | In distribution |
| G4TFU1622DS | Width.022 in | In distribution |
| G4TFU1818ACS | Width.018 in | In distribution |
| G4TFL1825ADS | Height.018 in | In distribution |
| G4TFL1818ACS | Height.018 in | In distribution |
| G4TFL014S | Outer Diameter.014 in | In distribution |
| G4TFL018AES | Outer Diameter.018 in | In distribution |
| PTTF192528S | Width.025 in | In distribution |
| G4TFL014ADS | Outer Diameter.014 in | In distribution |
| G4TFU1622ADS | Height.016 in | In distribution |
| PTTF192528ACS | Height.019 in | In distribution |
| G4TFU2020AES | Height.020 in | In distribution |
| G4TFS014S | Outer Diameter.014 in | In distribution |
| G4TFL1925S | Height.019 in | In distribution |
| G4TFU2020S | Width.020 in | In distribution |
| G4TFL1717DS | Height.017 in | In distribution |
| G4TFU2020ACS | Height.020 in | In distribution |
| G4TFL3622DS | Width.022 in | In distribution |
| G4TFL1616AES | Height.016 in | In distribution |
| G4TFU116S | Outer Diameter.016 in | In distribution |
| G4TFU1825ACS | Height.018 in | In distribution |
| G4TFU1818S | Width.018 in | In distribution |
| G4TFL1616S | Height.016 in | In distribution |
| PTTF172528ACS | Height.017 in | In distribution |
| G4TFU020S | Outer Diameter.020 in | In distribution |
| G4TFL016CS | Outer Diameter.016 in | In distribution |
| G4TFS018CS | Outer Diameter.018 in | In distribution |
| PTTF172528S | Height.017 in | In distribution |
| G4TFU1622ADS | Height.016 in | In distribution |
| G4TFU3622DS | Height.016 in | In distribution |
| G4TFU2020CS | Height.020 in | In distribution |
| G4TFL3622S | Width.022 in | In distribution |
| G4TFL2020AES | Height.020 in | In distribution |
| G4TFU020CS | Outer Diameter.020 in | In distribution |
| G4TFU1622AES | Height.016 in | In distribution |
| G4TFU1818AES | Height.018 in | In distribution |
| G4TFL112S | Outer Diameter.012 in | In distribution |
| PTTF212528AS | Height.021 in | In distribution |
| G4TFU014S | Outer Diameter.014 in | In distribution |
| G4TFU1717DS | Width.017 in | In distribution |
| G4TFL1925DS | Height.019 in | In distribution |
| G4TFL3622AS | Height.016 in | In distribution |
| G4TFL1925CS | Height.019 in | In distribution |
| PTTF212534AS | Height.021 in | In distribution |
| PTTF192534CS | Height.019 in | In distribution |
| PTTF192528CS | Height.019 in | In distribution |
| G4TFL1725DS | Width.025 in | In distribution |
| G4TFU1725AES | Height.017 in | In distribution |
| G4TFU1425ACS | Height.014 in | In distribution |
| G4TFU018ACS | Outer Diameter.018 in | In distribution |
| G4TFU014AS | Outer Diameter.014 in | In distribution |
| G4TFL018ADS | Outer Diameter.018 in | In distribution |
| G4TFU016AS | Outer Diameter.016 in | In distribution |
| G4TFU1925DS | Width.025 in | In distribution |
| PTTF192538AS | Height.019 in | In distribution |
| G4TFM1818S | Width.018 in | In distribution |
| PTTF172534AS | Height.017 in | In distribution |
| G4TFL014AS | Outer Diameter.014 in | In distribution |
| G4TFL1925ADS | Width.025 in | In distribution |
| G4TFU018CS | Outer Diameter.018 in | In distribution |
| G4TFU2020AS | Height.020 in | In distribution |
| G4TFL1825AES | Height.018 in | In distribution |
| G4TFL1717ADS | Height.017 in | In distribution |
| G4TFU3622AS | Height.016 in | In distribution |
| G4TFU016S | Outer Diameter.016 in | In distribution |
| G4TFL1825ACS | Width.025 in | In distribution |
| G4TFU114AS | Outer Diameter.014 in | In distribution |
| G4TFL1925AS | Width.025 in | In distribution |
| G4TFL014DS | Outer Diameter.014 in | In distribution |
| G4TFL012ADS | Outer Diameter.012 in | In distribution |
| G4TFM1925AS | Height.019 in | In distribution |
| G4TFL1725CS | Width.025 in | In distribution |
| G4TFS1825CS | Height.018 in | In distribution |
| G4TFL016ACS | Outer Diameter.016 in | In distribution |
| G4TFL1725AS | Height.017 in | In distribution |
| G4TFL1925AES | Height.019 in | In distribution |
| G4TFM1818AS | Width.018 in | In distribution |
| G4TFL3725S | Height.017 in | In distribution |
| G4TFU1825ACS | Height.018 in | In distribution |
| G4TFL020DS | Outer Diameter.020 in | In distribution |
| G4TFU1825ACS | Height.018 in | In distribution |
| PTTF172534S | Height.017 in | In distribution |
| G4TFU1725ACS | Height.017 in | In distribution |
| G4TFU1725DS | Height.017 in | In distribution |
| G4TFU1622S | Height.016 in | In distribution |
| G4TFL1825DS | Height.018 in | In distribution |
| G4TFM1825ACS | Height.018 in | In distribution |
| G4TFL1818AS | Height.018 in | In distribution |
| G4TFL016S | Outer Diameter.016 in | In distribution |
| G4TFU112S | Outer Diameter.012 in | In distribution |
| G4TFU3725AS | Width.025 in | In distribution |
| G4TFL116AS | Outer Diameter.016 in | In distribution |
| G4TFU012AS | Outer Diameter.012 in | In distribution |
Showing 250 of 276 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.