G4 Europa Nickel Titanium Solo-Pack
G4 NiTi, .017x.025 (,43mm x ,64mm), Upper, Europa Form II, Aesthetic, Solo-Pack
43manufacturers in China registered for this device type
519catalogue 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 |
|---|---|---|
| G4EFU112AS | Outer Diameter.012 in | In distribution |
| G4EFU3725DS | Width.025 in | In distribution |
| PTEF372538ACS | Width.025 in | In distribution |
| G4EFM120AS | Outer Diameter.020 in | In distribution |
| G4EFL3825ACS | Height.018 in | In distribution |
| G4EFU3725ADS | Width.025 in | In distribution |
| G4EFU3725AES | Width.025 in | In distribution |
| G4EFL018ACS | Outer Diameter.018 in | In distribution |
| G4EFL016AES | Outer Diameter.016 in | In distribution |
| G4EFL1925ACS | Height.019 in | In distribution |
| G4EFL1818AES | Width.018 in | In distribution |
| G4EFS3925S | Width.025 in | In distribution |
| G4EFL3818ACS | Height.018 in | In distribution |
| G4EFU1622AS | Height.016 in | In distribution |
| G4EFL120AS | Outer Diameter.020 in | In distribution |
| G4EFL3622S | Height.016 in | In distribution |
| G4EFS118AS | Outer Diameter.018 in | In distribution |
| G4EFU3725ADS | Height.017 in | In distribution |
| G4EFL2020AS | Width.020 in | In distribution |
| G4EFU3020ACS | Height.020 in | In distribution |
| G4EFU014CS | Outer Diameter.014 in | In distribution |
| G4EFL012AS | Outer Diameter.012 in | In distribution |
| G4EFM3425CS | Width.025 in | In distribution |
| G4EFL1825S | Height.018 in | In distribution |
| G4EFU114ADS | Outer Diameter.014 in | In distribution |
| G4EFL118ADS | Outer Diameter.018 in | In distribution |
| G4EFS118CS | Outer Diameter.018 in | In distribution |
| G4EFU3622ADS | Width.022 in | In distribution |
| G4EFU3925DS | Width.025 in | In distribution |
| G4EFM3825ACS | Height.018 in | In distribution |
| G4EFU120AES | Outer Diameter.020 in | In distribution |
| G4EFU1725AS | Height.017 in | In distribution |
| G4EFD013CS | Outer Diameter.013 in | In distribution |
| G4EFL3616ACS | Height.016 in | In distribution |
| G4EFL112DS | Outer Diameter.012 in | In distribution |
| G4EFU120ADS | Outer Diameter.020 in | In distribution |
| G4EFU018ADS | Outer Diameter.018 in | In distribution |
| G4EFL3622AS | Width.022 in | In distribution |
| G4EFU1425AS | Height.014 in | In distribution |
| G4EFL118ACS | Outer Diameter.018 in | In distribution |
| G4EFL3125S | Height.021 in | In distribution |
| G4EFS3425CS | Height.014 in | In distribution |
| G4EFS116S | Outer Diameter.016 in | In distribution |
| G4EFM114S | Outer Diameter.014 in | In distribution |
| G4EFS3925CS | Width.025 in | In distribution |
| G4EFM3622AS | Height.016 in | In distribution |
| PTEF372534AS | Height.017 in | In distribution |
| G4EFU3622ACS | Width.022 in | In distribution |
| G4EFM3616CS | Height.016 in | In distribution |
| G4EFL3725ADS | Width.025 in | In distribution |
| G4EFU118S | Outer Diameter.018 in | In distribution |
| G4EFL112AS | Outer Diameter.012 in | In distribution |
| G4EFL3625ACS | Width.025 in | In distribution |
| G4EFU1925AS | Height.019 in | In distribution |
| G4EFL1825AS | Width.025 in | In distribution |
| G4EFU3725AS | Height.017 in | In distribution |
| PTEF392538S | Height.019 in | In distribution |
| G4EFU3622S | Width.022 in | In distribution |
| PTEF372528AS | Height.017 in | In distribution |
| G4EFL1925AS | Height.019 in | In distribution |
| G4EFL1725AS | Height.017 in | In distribution |
| G4EFU3622DS | Width.022 in | In distribution |
| G4EFL020ACS | Outer Diameter.020 in | In distribution |
| G4EFU1818AS | Height.018 in | In distribution |
| PTEF392534S | Width.025 in | In distribution |
| G4EFU3725CS | Width.025 in | In distribution |
| G4EFS3625CS | Width.025 in | In distribution |
| G4EFL112AES | Outer Diameter.012 in | In distribution |
| G4EFL113ADS | Outer Diameter.013 in | In distribution |
| G4EFD1825CS | Width.025 in | In distribution |
| G4EFS3825CS | Width.025 in | In distribution |
| G4EFL3818ACS | Height.018 in | In distribution |
| G4EFL3425DS | Width.025 in | In distribution |
| G4EFS3625ACS | Height.016 in | In distribution |
| G4EFU113ACS | Outer Diameter.013 in | In distribution |
| G4EFU3622AES | Width.022 in | In distribution |
| G4EFU2125AS | Height.021 in | In distribution |
| G4EFM114CS | Outer Diameter.014 in | In distribution |
| G4EFL120DS | Outer Diameter.020 in | In distribution |
| G4EFL1622AS | Width.022 in | In distribution |
| G4EFL1925AES | Height.019 in | In distribution |
| G4EFM120S | Outer Diameter.020 in | In distribution |
| G4EFU1616AS | Width.016 in | In distribution |
| G4EFU3825AES | Height.018 in | In distribution |
| G4EFS3725S | Width.025 in | In distribution |
| G4EFU1622AS | Width.022 in | In distribution |
| G4EFL014S | Outer Diameter.014 in | In distribution |
| G4EFU013CS | Outer Diameter.013 in | In distribution |
| G4EFL1925DS | Width.025 in | In distribution |
| G4EFM112AS | Outer Diameter.012 in | In distribution |
| G4EFL3725DS | Width.025 in | In distribution |
| G4EFU016AS | Outer Diameter.016 in | In distribution |
| PTEF372534ACS | Height.017 in | In distribution |
| G4EFL1925S | Height.019 in | In distribution |
| G4EFU1425DS | Height.014 in | In distribution |
| G4EFU3625ACS | Width.025 in | In distribution |
| G4EFL1425AS | Height.014 in | In distribution |
| G4EFS3622S | Height.016 in | In distribution |
| G4EFL016S | Outer Diameter.016 in | In distribution |
| G4EFU018AS | Outer Diameter.018 in | In distribution |
| G4EFL112CS | Outer Diameter.012 in | In distribution |
| G4EFL1825AES | Width.025 in | In distribution |
| G4EFU116AS | Outer Diameter.016 in | In distribution |
| G4EFM3425ACS | Height.014 in | In distribution |
| G4EFL1818AS | Width.018 in | In distribution |
| G4EFU3020CS | Height.020 in | In distribution |
| G4EFS3925AS | Width.025 in | In distribution |
| G4EFU114S | Outer Diameter.014 in | In distribution |
| PTEF372538AS | Width.025 in | In distribution |
| G4EFU113ADS | Outer Diameter.013 in | In distribution |
| G4EFL1725DS | Height.017 in | In distribution |
| G4EFU018DS | Outer Diameter.018 in | In distribution |
| G4EFL112ADS | Outer Diameter.012 in | In distribution |
| G4EFS116AS | Outer Diameter.016 in | In distribution |
| G4EFM112S | Outer Diameter.012 in | In distribution |
| G4EFU3925S | Height.019 in | In distribution |
| G4EFU016AS | Outer Diameter.016 in | In distribution |
| G4EFS3825ACS | Width.025 in | In distribution |
| G4EFM118AS | Outer Diameter.018 in | In distribution |
| G4EFL114CS | Outer Diameter.014 in | In distribution |
| G4EFL016DS | Outer Diameter.016 in | In distribution |
| G4EFU014S | Outer Diameter.014 in | In distribution |
| G4EFM3425AS | Height.014 in | In distribution |
| G4EFL3425S | Width.025 in | In distribution |
| G4EFU1818AES | Width.018 in | In distribution |
| G4EFU012AS | Outer Diameter.012 in | In distribution |
| G4EFL1925CS | Width.025 in | In distribution |
| G4EFU118CS | Outer Diameter.018 in | In distribution |
| G4EFL3725AS | Height.017 in | In distribution |
| G4EFL1616AS | Width.016 in | In distribution |
| G4EFL3425CS | Width.025 in | In distribution |
| G4EFU118ACS | Outer Diameter.018 in | In distribution |
| G4EFL113ADS | Outer Diameter.013 in | In distribution |
| G4EFU3925CS | Height.019 in | In distribution |
| G4EFL112ACS | Outer Diameter.012 in | In distribution |
| PTEF392528ACS | Height.019 in | In distribution |
| G4EFM3825CS | Width.025 in | In distribution |
| G4EFU1725AES | Height.017 in | In distribution |
| G4EFU3725ACS | Height.017 in | In distribution |
| G4EFU113DS | Outer Diameter.013 in | In distribution |
| G4EFL114AS | Outer Diameter.014 in | In distribution |
| G4EFL3625AS | Width.025 in | In distribution |
| G4EFM3825S | Height.018 in | In distribution |
| G4EFL114DS | Outer Diameter.014 in | In distribution |
| G4EFL120CS | Outer Diameter.020 in | In distribution |
| G4EFL3925AS | Width.025 in | In distribution |
| G4EFU3616ACS | Height.016 in | In distribution |
| G4EFL114S | Outer Diameter.014 in | In distribution |
| G4EFL118ACSE | Outer Diameter.018 in | In distribution |
| G4EFL113S | Outer Diameter.013 in | In distribution |
| G4EFU3425AS | Height.014 in | In distribution |
| G4EFL113CS | Outer Diameter.013 in | In distribution |
| G4EFL016ACS | Outer Diameter.016 in | In distribution |
| G4EFD018ACS | Outer Diameter.018 in | In distribution |
| G4EFL118AS | Outer Diameter.018 in | In distribution |
| G4EFU1616AS | Height.016 in | In distribution |
| G4EFL012AS | Outer Diameter.012 in | In distribution |
| G4EFL120ADS | Outer Diameter.020 in | In distribution |
| G4EFU3825AS | Height.018 in | In distribution |
| G4EFD1425ACS | Width.025 in | In distribution |
| G4EFS3825S | Width.025 in | In distribution |
| G4EFL014AES | Outer Diameter.014 in | In distribution |
| G4EFL012DS | Outer Diameter.012 in | In distribution |
| G4EFL1622ADS | Width.022 in | In distribution |
| G4EFD1625ACS | Width.025 in | In distribution |
| G4EFU1425ACS | Width.025 in | In distribution |
| G4EFL3020S | Height.020 in | In distribution |
| G4EFL1622DS | Width.022 in | In distribution |
| G4EFU3818CS | Height.018 in | In distribution |
| G4EFL020AS | Outer Diameter.020 in | In distribution |
| G4EFU014DS | Outer Diameter.014 in | In distribution |
| G4EFU3625DS | Height.016 in | In distribution |
| G4EFU1725DS | Height.017 in | In distribution |
| G4EFU3616S | Width.016 in | In distribution |
| PTEF362534AS | Width.025 in | In distribution |
| G4EFL020S | Outer Diameter.020 in | In distribution |
| G4EFL1725CS | Height.017 in | In distribution |
| G4EFU120DS | Outer Diameter.020 in | In distribution |
| G4EFU3125AS | Width.025 in | In distribution |
| G4EFL118S | Outer Diameter.018 in | In distribution |
| G4EFU3616CS | Height.016 in | In distribution |
| G4EFL116AS | Outer Diameter.016 in | In distribution |
| G4EFL116ACS | Outer Diameter.016 in | In distribution |
| G4EFM114ACS | Outer Diameter.014 in | In distribution |
| G4EFL1818AS | Width.018 in | In distribution |
| G4EFS120AS | Outer Diameter.020 in | In distribution |
| G4EFS3425AS | Width.025 in | In distribution |
| G4EFL3818DS | Width.018 in | In distribution |
| G4EFU112ACS | Outer Diameter.012 in | In distribution |
| G4EFS3925ACS | Height.019 in | In distribution |
| G4EFU114AS | Outer Diameter.014 in | In distribution |
| G4EFU012S | Outer Diameter.012 in | In distribution |
| G4EFD018CS | Outer Diameter.018 in | In distribution |
| G4EFL3622AES | Width.022 in | In distribution |
| G4EFL3725AES | Height.017 in | In distribution |
| G4EFS3725CS | Height.017 in | In distribution |
| G4EFL3725CS | Width.025 in | In distribution |
| G4EFL116ADS | Outer Diameter.016 in | In distribution |
| G4EFD014CS | Outer Diameter.014 in | In distribution |
| G4EFL3020AS | Width.020 in | In distribution |
| G4EFL016AS | Outer Diameter.016 in | In distribution |
| G4EFL1925AS | Width.025 in | In distribution |
| G4EFS114ACS | Outer Diameter.014 in | In distribution |
| G4EFL3725ADS | Width.025 in | In distribution |
| G4EFU016AES | Outer Diameter.016 in | In distribution |
| G4EFL114ACSE | Outer Diameter.014 in | In distribution |
| G4EFL3622ACS | Width.022 in | In distribution |
| G4EFL1818S | Width.018 in | In distribution |
| G4EFL014CS | Outer Diameter.014 in | In distribution |
| PTEF362538AS | Width.025 in | In distribution |
| G4EFL1425CS | Width.025 in | In distribution |
| G4EFU113S | Outer Diameter.013 in | In distribution |
| G4EFU1625CS | Height.016 in | In distribution |
| PTEF362534S | Height.016 in | In distribution |
| G4EFM114AS | Outer Diameter.014 in | In distribution |
| G4EFL1818AS | Width.018 in | In distribution |
| G4EFU3622ADS | Height.016 in | In distribution |
| G4EFU1622CS | Height.016 in | In distribution |
| G4EFL1925AS | Width.025 in | In distribution |
| G4EFU016DS | Outer Diameter.016 in | In distribution |
| G4EFL1425S | Width.025 in | In distribution |
| G4EFU1825S | Width.025 in | In distribution |
| G4EFU116ADS | Outer Diameter.016 in | In distribution |
| G4EFL3818ADS | Width.018 in | In distribution |
| G4EFU114ACS | Outer Diameter.014 in | In distribution |
| G4EFL020CS | Outer Diameter.020 in | In distribution |
| G4EFD1825ACS | Width.025 in | In distribution |
| G4EFU3725S | Height.017 in | In distribution |
| G4EFU016CS | Outer Diameter.016 in | In distribution |
| G4EFU3625CS | Height.016 in | In distribution |
| G4EFD1625CS | Height.016 in | In distribution |
| G4EFM116S | Outer Diameter.016 in | In distribution |
| G4EFS3925AS | Width.025 in | In distribution |
| G4EFU018AS | Outer Diameter.018 in | In distribution |
| G4EFU012AS | Outer Diameter.012 in | In distribution |
| G4EFU116CS | Outer Diameter.016 in | In distribution |
| G4EFU114ACS | Outer Diameter.014 in | In distribution |
| G4EFD1425CS | Height.014 in | In distribution |
| G4EFS118S | Outer Diameter.018 in | In distribution |
| G4EFU120ADS | Outer Diameter.020 in | In distribution |
| G4EFL1625AS | Height.016 in | In distribution |
| G4EFS114CS | Outer Diameter.014 in | In distribution |
| G4EFU1725AS | Width.025 in | In distribution |
| PTEF392528CS | Width.025 in | In distribution |
| G4EFL1622CS | Width.022 in | In distribution |
| G4EFL3625DS | Height.016 in | In distribution |
| G4EFM3622S | Height.016 in | In distribution |
| G4EFU1625AS | Height.016 in | In distribution |
| G4EFU3825CS | Height.018 in | In distribution |
| G4EFL3616CS | Height.016 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.