XR1 Europa Heat-Treated Stainless Steel
XR1 SS Efii 92%.016X.025
43manufacturers in China registered for this device type
151catalogue 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 |
| 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 | Per pack | Status |
|---|---|---|---|
| XREFU3825 | Width.025 in | 25 | In distribution |
| XREFU1825A | Width.025 in | 25 | In distribution |
| XREFU114A | Outer Diameter.014 in | 25 | In distribution |
| XREFL1818 | Height.018 in | 25 | In distribution |
| XREFL120 | Outer Diameter.020 in | 25 | In distribution |
| XREFU1822A | Width.022 in | 25 | In distribution |
| XREFL114A | Outer Diameter.014 in | 25 | In distribution |
| XREFM3625A | Width.025 in | 25 | In distribution |
| XREFU116 | Outer Diameter.016 in | 25 | In distribution |
| XREFU1722A | Height.017 in | 25 | In distribution |
| XREFU2020 | Width.020 in | 25 | In distribution |
| XREFU1725A | Width.025 in | 25 | In distribution |
| XREFL016 | Outer Diameter.016 in | 25 | In distribution |
| XREFL3925A | Height.019 in | 25 | In distribution |
| XREFL3825A | Width.025 in | 25 | In distribution |
| XREFU1825 | Height.018 in | 25 | In distribution |
| XREFU016A | Outer Diameter.016 in | 25 | In distribution |
| XREFL1722 | Height.017 in | 25 | In distribution |
| XREFU112A | Outer Diameter.012 in | 25 | In distribution |
| XREFL1818A | Width.018 in | 25 | In distribution |
| XREFU3625 | Width.025 in | 25 | In distribution |
| XREFU2125 | Height.021 in | 25 | In distribution |
| XREFS3925A | Width.025 in | 25 | In distribution |
| XREFL112 | Outer Diameter.012 in | 25 | In distribution |
| XREFU118 | Outer Diameter.018 in | 25 | In distribution |
| XREFL3725A | Width.025 in | 25 | In distribution |
| XREFL3925 | Width.025 in | 25 | In distribution |
| XREFL3825 | Height.018 in | 25 | In distribution |
| XREFL014 | Outer Diameter.014 in | 25 | In distribution |
| XREFU114 | Outer Diameter.014 in | 25 | In distribution |
| XREFU3622A | Width.022 in | 25 | In distribution |
| XREFL114 | Outer Diameter.014 in | 25 | In distribution |
| XREFU014A | Outer Diameter.014 in | 25 | In distribution |
| XREFL016A | Outer Diameter.016 in | 25 | In distribution |
| XREFU1925 | Width.025 in | 25 | In distribution |
| XREFU3818A | Width.018 in | 25 | In distribution |
| XREFL3822A | Width.022 in | 25 | In distribution |
| XREFL116A | Outer Diameter.016 in | 25 | In distribution |
| XREFM3925 | Width.025 in | 25 | In distribution |
| XREFU1818 | Width.018 in | 25 | In distribution |
| XREFU3925 | Height.019 in | 25 | In distribution |
| XREFU3925A | Width.025 in | 25 | In distribution |
| XREFU3622A | Height.016 in | 25 | In distribution |
| XREFL012 | Outer Diameter.012 in | 25 | In distribution |
| XREFU016 | Outer Diameter.016 in | 25 | In distribution |
| XREFL3020A | Height.020 in | 25 | In distribution |
| XREFL118A | Outer Diameter.018 in | 25 | In distribution |
| XREFL1725 | Width.025 in | 25 | In distribution |
| XREFU1622A | Height.016 in | 25 | In distribution |
| XREFL1622 | Height.016 in | 25 | In distribution |
| XREFU2020A | Height.020 in | 25 | In distribution |
| XREFU3625A | Width.025 in | 25 | In distribution |
| XREFU1625A | Height.016 in | 25 | In distribution |
| XREFL018A | Outer Diameter.018 in | 25 | In distribution |
| XREFL1822A | Height.018 in | 25 | In distribution |
| XREFU118A | Outer Diameter.018 in | 25 | In distribution |
| XREFL3925A | Width.025 in | 25 | In distribution |
| XREFU3818 | Height.018 in | 25 | In distribution |
| XREFL3125 | Width.025 in | 25 | In distribution |
| XREFU020 | Outer Diameter.020 in | 25 | In distribution |
| XREFL1616 | Width.016 in | 25 | In distribution |
| XREFU020A | Outer Diameter.020 in | 25 | In distribution |
| XREFU112 | Outer Diameter.012 in | 25 | In distribution |
| XREFS3625A | Width.025 in | 25 | In distribution |
| XREFL3622A | Width.022 in | 25 | In distribution |
| XREFL1725A | Width.025 in | 25 | In distribution |
| XREFL1625 | Height.016 in | 25 | In distribution |
| XREFL3622A | Height.016 in | 25 | In distribution |
| XREFL120A | Outer Diameter.020 in | 25 | In distribution |
| XREFL2125 | Height.021 in | 25 | In distribution |
| XREFL2125A | Height.021 in | 25 | In distribution |
| XREFL3622A | Width.022 in | 25 | In distribution |
| XREFL020A | Outer Diameter.020 in | 25 | In distribution |
| XREFU1717A | Width.017 in | 25 | In distribution |
| XREFS3625 | Height.016 in | 25 | In distribution |
| XREFL3725 | Width.025 in | 25 | In distribution |
| XREFU1616 | Height.016 in | 25 | In distribution |
| XREFU3616 | Height.016 in | 25 | In distribution |
| XREFL3822 | Height.018 in | 25 | In distribution |
| XREFU3725 | Height.017 in | 25 | In distribution |
| XREFU3725A | Height.017 in | 25 | In distribution |
| XREFU1616A | Width.016 in | 25 | In distribution |
| XREFU2125A | Width.025 in | 25 | In distribution |
| XREFL116 | Outer Diameter.016 in | 25 | In distribution |
| XREFU3020 | Height.020 in | 25 | In distribution |
| XREFL1717A | Height.017 in | 25 | In distribution |
| XREFU3622 | Width.022 in | 25 | In distribution |
| XREFU3722A | Height.017 in | 25 | In distribution |
| XREFL1722A | Height.017 in | 25 | In distribution |
| XREFL3622 | Height.016 in | 25 | In distribution |
| XREFL1616A | Width.016 in | 25 | In distribution |
| XREFU3822A | Height.018 in | 25 | In distribution |
| XREFU3825A | Height.018 in | 25 | In distribution |
| XREFL014A | Outer Diameter.014 in | 25 | In distribution |
| XREFL118 | Outer Diameter.018 in | 25 | In distribution |
| XREFU018A | Outer Diameter.018 in | 25 | In distribution |
| XREFU1725 | Width.025 in | 25 | In distribution |
| XREFU120A | Outer Diameter.020 in | 25 | In distribution |
| XREFU014 | Outer Diameter.014 in | 25 | In distribution |
| XREFL3717 | Height.017 in | 25 | In distribution |
| XREFL1622A | Height.016 in | 25 | In distribution |
| XREFU3020A | Width.020 in | 25 | In distribution |
| XREFS3125A | Height.021 in | 25 | In distribution |
| XREFM3925A | Width.025 in | 25 | In distribution |
| XREFM3925A | Width.025 in | 25 | In distribution |
| XREFL1625A | Height.016 in | 25 | In distribution |
| XREFU3822 | Width.022 in | 25 | In distribution |
| XREFU3722 | Width.022 in | 25 | In distribution |
| XREFU3125 | Width.025 in | 25 | In distribution |
| XREFL3925A | Width.025 in | 25 | In distribution |
| XREFU3616A | Width.016 in | 25 | In distribution |
| XREFU3020A | Width.020 in | 25 | In distribution |
| XREFL3616 | Width.016 in | 25 | In distribution |
| XREFL2020A | Width.020 in | 25 | In distribution |
| XREFL3616A | Width.016 in | 25 | In distribution |
| XREFU012A | Outer Diameter.012 in | 25 | In distribution |
| XREFL2020 | Height.020 in | 25 | In distribution |
| XREFL012A | Outer Diameter.012 in | 25 | In distribution |
| XREFL3625A | Width.025 in | 25 | In distribution |
| XREFS3125 | Height.021 in | 25 | In distribution |
| XREFL3125A | Height.021 in | 25 | In distribution |
| XREFU018 | Outer Diameter.018 in | 25 | In distribution |
| XREFU1625 | Width.025 in | 25 | In distribution |
| XREFU012 | Outer Diameter.012 in | 25 | In distribution |
| XREFM3925A | Width.025 in | 25 | In distribution |
| XREFU3622A | Height.016 in | 25 | In distribution |
| XREFM3625 | Height.016 in | 25 | In distribution |
| XREFU116A | Outer Diameter.016 in | 25 | In distribution |
| XREFS3925 | Height.019 in | 25 | In distribution |
| XREFU1925A | Width.025 in | 25 | In distribution |
| XREFL1925A | Height.019 in | 25 | In distribution |
| XREFL3020 | Width.020 in | 25 | In distribution |
| XREFL1925 | Width.025 in | 25 | In distribution |
| XREFL1717 | Height.017 in | 25 | In distribution |
| XREFU3925A | Height.019 in | 25 | In distribution |
| XREFL1825A | Height.018 in | 25 | In distribution |
| XREFL112A | Outer Diameter.012 in | 25 | In distribution |
| XREFU120 | Outer Diameter.020 in | 25 | In distribution |
| XREFU3020A | Width.020 in | 25 | In distribution |
| XREFU1822 | Height.018 in | 25 | In distribution |
| XREFL3722 | Width.022 in | 25 | In distribution |
| XREFU1622 | Width.022 in | 25 | In distribution |
| XREFU1722 | Width.022 in | 25 | In distribution |
| XREFU1717 | Width.017 in | 25 | In distribution |
| XREFU3925A | Height.019 in | 25 | In distribution |
| XREFU3125A | Width.025 in | 25 | In distribution |
| XREFL1825 | Height.018 in | 25 | In distribution |
| XREFL018 | Outer Diameter.018 in | 25 | In distribution |
| XREFL1822 | Height.018 in | 25 | In distribution |
| XREFL020 | Outer Diameter.020 in | 25 | In distribution |
| XREFL3625 | Height.016 in | 25 | 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
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.