Europa Solo-Pack
Superelastic NiTi, .016x.022 (,41mm x ,56mm), Upper, Europa Form II, Aesthetic, Solo-Pack
43manufacturers in China registered for this device type
649catalogue 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 | Height 0.014 to 0.021 in; width 0.016 to 0.025 in; outer diameter 0.012 to 0.02 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TEFL3425DS | Height.014 in | In distribution |
| SEEFU1825AES | Height.018 in | In distribution |
| SEEFU2020AS | Height.020 in | In distribution |
| SEEFU3725S | Height.017 in | In distribution |
| TEFU3725AS | Width.025 in | In distribution |
| SSEFL3825AS | Width.025 in | In distribution |
| TEFU3020S | Height.020 in | In distribution |
| SSEFL1622AS | Height.016 in | In distribution |
| CUEFU3825S | Height.018 in | In distribution |
| SEEFL114DS | Outer Diameter.014 in | In distribution |
| SSEFU012S | Outer Diameter.012 in | In distribution |
| SSEFL3616GS | Height.016 in | In distribution |
| TEFU018DS | Outer Diameter.018 in | In distribution |
| TEFL3622ADS | Height.016 in | In distribution |
| SSEFL120AES | Outer Diameter.020 in | In distribution |
| TEFL014DS | Outer Diameter.014 in | In distribution |
| SSEFU1622AS | Height.016 in | In distribution |
| CUEFU3625CS | Height.016 in | In distribution |
| SSEFL3725AS | Width.025 in | In distribution |
| SEEFL3925S | Width.025 in | In distribution |
| SSEFL3622GAS | Width.022 in | In distribution |
| SEEFU1625S | Height.016 in | In distribution |
| SEEFL3020AS | Height.020 in | In distribution |
| SSEFS3625S | Height.016 in | In distribution |
| SEEFL3020ADS | Height.020 in | In distribution |
| SEEFU1725ADS | Height.017 in | In distribution |
| CUEFU3825CS | Height.018 in | In distribution |
| SEEFU3622AES | Width.022 in | In distribution |
| SEEFL113S | Outer Diameter.013 in | In distribution |
| SEEFL2125S | Width.025 in | In distribution |
| SEEFU114AES | Outer Diameter.014 in | In distribution |
| TEFL3625AS | Width.025 in | In distribution |
| SSEFL020AS | Outer Diameter.020 in | In distribution |
| CUEFL016S | Outer Diameter.016 in | In distribution |
| SEEFU1616DS | Height.016 in | In distribution |
| SEEFM116CS | Outer Diameter.016 in | In distribution |
| TEFU014AS | Outer Diameter.014 in | In distribution |
| SEEFL1925S | Width.025 in | In distribution |
| SEEFU012DS | Outer Diameter.012 in | In distribution |
| SEEFU1925S | Width.025 in | In distribution |
| CUEFL2020S | Height.020 in | In distribution |
| TEFU1616DS | Width.016 in | In distribution |
| SEEFL3125AS | Height.021 in | In distribution |
| SEEFL3825CS | Height.018 in | In distribution |
| CUEFU1622S | Width.022 in | In distribution |
| TEFU018S | Outer Diameter.018 in | In distribution |
| SEEFL014DS | Outer Diameter.014 in | In distribution |
| SSEFL3125S | Height.021 in | In distribution |
| SSEFU3625S | Height.016 in | In distribution |
| SEEFU120S | Outer Diameter.020 in | In distribution |
| SEEFU3616AS | Height.016 in | In distribution |
| SEEFL016S | Outer Diameter.016 in | In distribution |
| TEFU3425ADS | Height.014 in | In distribution |
| SEEFU116ACS | Outer Diameter.016 in | In distribution |
| CUEFL014S | Outer Diameter.014 in | In distribution |
| SEEFS116ACS | Outer Diameter.016 in | In distribution |
| SSEFL020S | Outer Diameter.020 in | In distribution |
| TEFU1622ADS | Width.022 in | In distribution |
| SEEFU2125AS | Width.025 in | In distribution |
| SSEFU3925AS | Height.019 in | In distribution |
| SEEFL3425ACS | Height.014 in | In distribution |
| SSEFU3622GAS | Width.022 in | In distribution |
| SEEFL020AES | Outer Diameter.020 in | In distribution |
| SSEFL1616AS | Height.016 in | In distribution |
| SEEFL116S | Outer Diameter.016 in | In distribution |
| SSEFL016AES | Outer Diameter.016 in | In distribution |
| TEFL3625S | Width.025 in | In distribution |
| SEEFL012AS | Outer Diameter.012 in | In distribution |
| SEEFL3622ACS | Height.016 in | In distribution |
| SEEFL118AS | Outer Diameter.018 in | In distribution |
| SSEFL1925S | Width.025 in | In distribution |
| SEEFL1818AES | Width.018 in | In distribution |
| SEEFL1825S | Height.018 in | In distribution |
| TEFL2125ADS | Width.025 in | In distribution |
| TEFL1925AS | Width.025 in | In distribution |
| SSEFL2125AS | Height.021 in | In distribution |
| TEFU018AS | Outer Diameter.018 in | In distribution |
| CUEFL116CS | Outer Diameter.016 in | In distribution |
| SEEFU1825S | Height.018 in | In distribution |
| SEEFU3625ADS | Height.016 in | In distribution |
| SEEFU018DS | Outer Diameter.018 in | In distribution |
| SEEFL120ADS | Outer Diameter.020 in | In distribution |
| SEEFU1925ADS | Height.019 in | In distribution |
| SEEFL018CS | Outer Diameter.018 in | In distribution |
| SEEFU116ACS | Outer Diameter.016 in | In distribution |
| SSEFU2125AES | Height.021 in | In distribution |
| TEFL1825AS | Height.018 in | In distribution |
| TEFU1925AS | Width.025 in | In distribution |
| TEFL1725AS | Height.017 in | In distribution |
| SSEFL018GAS | Outer Diameter.018 in | In distribution |
| TEFL3925S | Height.019 in | In distribution |
| SSEFU1825AES | Height.018 in | In distribution |
| TEFL2125S | Height.021 in | In distribution |
| SSEFU016AES | Outer Diameter.016 in | In distribution |
| CUEFL118S | Outer Diameter.018 in | In distribution |
| SSEFU018GAS | Outer Diameter.018 in | In distribution |
| TEFL012AS | Outer Diameter.012 in | In distribution |
| SSEFL114S | Outer Diameter.014 in | In distribution |
| SEEFU013S | Outer Diameter.013 in | In distribution |
| SEEFL1622AS | Height.016 in | In distribution |
| TEFU116AS | Outer Diameter.016 in | In distribution |
| SEEFU016AS | Outer Diameter.016 in | In distribution |
| TEFU3825DS | Width.025 in | In distribution |
| TEFL116S | Outer Diameter.016 in | In distribution |
| SEEFU3622ACS | Width.022 in | In distribution |
| SEEFL116AS | Outer Diameter.016 in | In distribution |
| SEEFL114ADS | Outer Diameter.014 in | In distribution |
| SSEFU3616GS | Width.016 in | In distribution |
| SSEFU1622S | Width.022 in | In distribution |
| TEFU3825ADS | Width.025 in | In distribution |
| TEFU3825S | Height.018 in | In distribution |
| TEFU114AS | Outer Diameter.014 in | In distribution |
| TEFU016ADS | Outer Diameter.016 in | In distribution |
| SSEFL014AS | Outer Diameter.014 in | In distribution |
| SEEFL1925AES | Height.019 in | In distribution |
| SEEFU3925AES | Height.019 in | In distribution |
| SEEFU020S | Outer Diameter.020 in | In distribution |
| SEEFS116CS | Outer Diameter.016 in | In distribution |
| SEEFU3020AS | Height.020 in | In distribution |
| SEEFU113S | Outer Diameter.013 in | In distribution |
| SEEFU1625AS | Width.025 in | In distribution |
| SEEFU118AS | Outer Diameter.018 in | In distribution |
| SEEFL114ACS | Outer Diameter.014 in | In distribution |
| TEFL016DS | Outer Diameter.016 in | In distribution |
| SSEFL012AS | Outer Diameter.012 in | In distribution |
| CUEFL112S | Outer Diameter.012 in | In distribution |
| SEEFL116AS | Outer Diameter.016 in | In distribution |
| SEEFU3725AS | Height.017 in | In distribution |
| TEFL1616DS | Height.016 in | In distribution |
| TEFL3825S | Height.018 in | In distribution |
| SEEFU3625AS | Height.016 in | In distribution |
| SEEFL3425ACS | Width.025 in | In distribution |
| SEEFL3625ACS | Height.016 in | In distribution |
| SEEFU1925AS | Width.025 in | In distribution |
| SSEFU012AS | Outer Diameter.012 in | In distribution |
| SEEFU3020ADS | Height.020 in | In distribution |
| TEFL112S | Outer Diameter.012 in | In distribution |
| SEEFU1625ADS | Width.025 in | In distribution |
| SEEFU116AS | Outer Diameter.016 in | In distribution |
| SEEFL112CS | Outer Diameter.012 in | In distribution |
| SEEFU1825AS | Width.025 in | In distribution |
| SEEFL3925DS | Height.019 in | In distribution |
| TEFU1925DS | Width.025 in | In distribution |
| SSEFU118AS | Outer Diameter.018 in | In distribution |
| SSEFU120S | Outer Diameter.020 in | In distribution |
| TEFU3925S | Width.025 in | In distribution |
| TEFU2125DS | Width.025 in | In distribution |
| SSEFU114S | Outer Diameter.014 in | In distribution |
| SSEFL1822AS | Height.018 in | In distribution |
| SEEFU3925ADS | Width.025 in | In distribution |
| SEEFL1925DS | Width.025 in | In distribution |
| SEEFU3425S | Height.014 in | In distribution |
| TEFU3825AS | Width.025 in | In distribution |
| SEEFL2020AES | Height.020 in | In distribution |
| SEEFL112ACS | Outer Diameter.012 in | In distribution |
| SEEFL014CS | Outer Diameter.014 in | In distribution |
| TEFL012AS | Outer Diameter.012 in | In distribution |
| TEFL016ADS | Outer Diameter.016 in | In distribution |
| TEFL014AS | Outer Diameter.014 in | In distribution |
| SEEFU012AS | Outer Diameter.012 in | In distribution |
| SEEFL112AS | Outer Diameter.012 in | In distribution |
| SEEFU1825AS | Width.025 in | In distribution |
| SEEFL3425S | Width.025 in | In distribution |
| TEFU020AS | Outer Diameter.020 in | In distribution |
| TEFU3425S | Width.025 in | In distribution |
| TEFL1616ADS | Height.016 in | In distribution |
| SEEFU014AS | Outer Diameter.014 in | In distribution |
| SEEFL3925CS | Height.019 in | In distribution |
| SEEFU1622AES | Height.016 in | In distribution |
| TEFU2125ADS | Width.025 in | In distribution |
| SEEFL018S | Outer Diameter.018 in | In distribution |
| SSEFU1825AS | Width.025 in | In distribution |
| TEFL1725S | Width.025 in | In distribution |
| TEFL118S | Outer Diameter.018 in | In distribution |
| SEEFL1725S | Height.017 in | In distribution |
| SSEFU118AES | Outer Diameter.018 in | In distribution |
| SSEFL016S | Outer Diameter.016 in | In distribution |
| SEEFL1622DS | Width.022 in | In distribution |
| SEEFL1925AS | Height.019 in | In distribution |
| SSEFL012S | Outer Diameter.012 in | In distribution |
| SSEFU014AS | Outer Diameter.014 in | In distribution |
| TEFU3616AS | Width.016 in | In distribution |
| SEEFU1616ADS | Height.016 in | In distribution |
| SEEFU120ADS | Outer Diameter.020 in | In distribution |
| SSEFL2125S | Height.021 in | In distribution |
| SSEFL3825S | Height.018 in | In distribution |
| SSEFU1622AES | Width.022 in | In distribution |
| SSEFU1616S | Width.016 in | In distribution |
| TEFL018ADS | Outer Diameter.018 in | In distribution |
| SEEFL1622AES | Height.016 in | In distribution |
| SEEFU3825AS | Width.025 in | In distribution |
| SEEFL120S | Outer Diameter.020 in | In distribution |
| SEEFU016AS | Outer Diameter.016 in | In distribution |
| SSEFL1616S | Width.016 in | In distribution |
| TEFU016S | Outer Diameter.016 in | In distribution |
| TEFL1925AS | Height.019 in | In distribution |
| SEEFU1616AS | Height.016 in | In distribution |
| SEEFL020S | Outer Diameter.020 in | In distribution |
| SEEFU3725ACS | Width.025 in | In distribution |
| SSEFL1622AS | Height.016 in | In distribution |
| TEFU2020S | Height.020 in | In distribution |
| SEEFL3725AS | Width.025 in | In distribution |
| SEEFL116ACS | Outer Diameter.016 in | In distribution |
| TEFL014S | Outer Diameter.014 in | In distribution |
| SSEFU1925GS | Width.025 in | In distribution |
| SEEFU3725CS | Width.025 in | In distribution |
| TEFU1725ADS | Width.025 in | In distribution |
| TEFU1818S | Height.018 in | In distribution |
| SSEFU3725S | Height.017 in | In distribution |
| CUEFU118S | Outer Diameter.018 in | In distribution |
| TEFU012S | Outer Diameter.012 in | In distribution |
| SEEFU3925DS | Height.019 in | In distribution |
| CUEFU120S | Outer Diameter.020 in | In distribution |
| SSEFL1725S | Height.017 in | In distribution |
| SSEFL1925AS | Width.025 in | In distribution |
| TEFU1622DS | Height.016 in | In distribution |
| TEFL014ADS | Outer Diameter.014 in | In distribution |
| TEFL114AS | Outer Diameter.014 in | In distribution |
| SEEFL018ACS | Outer Diameter.018 in | In distribution |
| SEEFL1622ADS | Height.016 in | In distribution |
| SEEFL3625CS | Width.025 in | In distribution |
| SEEFL3616AS | Width.016 in | In distribution |
| SEEFL020AS | Outer Diameter.020 in | In distribution |
| SEEFU116AES | Outer Diameter.016 in | In distribution |
| SEEFL016ADS | Outer Diameter.016 in | In distribution |
| TEFU1616AS | Height.016 in | In distribution |
| SSEFL3125AS | Height.021 in | In distribution |
| TEFU018ADS | Outer Diameter.018 in | In distribution |
| SSEFU120AS | Outer Diameter.020 in | In distribution |
| TEFL1925AS | Height.019 in | In distribution |
| CUEFL3622CS | Width.022 in | In distribution |
| SEEFU013AS | Outer Diameter.013 in | In distribution |
| SEEFL118ACS | Outer Diameter.018 in | In distribution |
| SSEFU2125AS | Width.025 in | In distribution |
| SSEFU1616AS | Height.016 in | In distribution |
| TEFL1622AS | Width.022 in | In distribution |
| SSEFU3625AS | Height.016 in | In distribution |
| SEEFU116S | Outer Diameter.016 in | In distribution |
| SEEFU2125S | Height.021 in | In distribution |
| SEEFU012AS | Outer Diameter.012 in | In distribution |
| SEEFU116AS | Outer Diameter.016 in | In distribution |
| TEFL2020S | Width.020 in | In distribution |
| SEEFU014S | Outer Diameter.014 in | In distribution |
| SEEFL012DS | Outer Diameter.012 in | In distribution |
| SEEFU2020S | Width.020 in | In distribution |
| TEFL1825S | Width.025 in | In distribution |
| TEFU020DS | Outer Diameter.020 in | In distribution |
| SEEFL3925ACS | Height.019 in | In distribution |
| SEEFL1616DS | Height.016 in | In distribution |
| SSEFL1825AES | Height.018 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.