XR1 Heat-Treated Stainless Steel
XR1 BALL POST EUROPA II 016x025 - 40MM
43manufacturers in China registered for this device type
385catalogue 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 |
|---|---|---|---|
| XRBF3L1925 | Width.025 in | 25 | In distribution |
| PXBB3162228A | Width.022 in | 10 | In distribution |
| PXBT162242A | Height.016 in | 10 | In distribution |
| XRSFL1825A | Height.018 in | 25 | In distribution |
| XRBF3U1925A | Height.019 in | 25 | In distribution |
| PXBD362540 | Width.025 in | 10 | In distribution |
| XRSFL1825 | Height.018 in | 25 | In distribution |
| PXBE192522A | Height.019 in | 10 | In distribution |
| XRBF3U2125A | Width.025 in | 25 | In distribution |
| XRBF512 | Outer Diameter.012 in | 25 | In distribution |
| XRBF21622 | Height.016 in | 25 | In distribution |
| PXBE192538A | Height.019 in | 10 | In distribution |
| PXBB3162240A | Height.016 in | 10 | In distribution |
| PXBD192544 | Width.025 in | 10 | In distribution |
| XRBF3L1616A | Height.016 in | 25 | In distribution |
| XRSFL1616A | Width.016 in | 25 | In distribution |
| XRBF216 | Outer Diameter.016 in | 25 | In distribution |
| PXBB3162222A | Height.016 in | 10 | In distribution |
| XRBF11722A | Height.017 in | 25 | In distribution |
| PXBT162234 | Width.022 in | 10 | In distribution |
| PXBD362540A | Height.016 in | 10 | In distribution |
| XRBF11925 | Height.019 in | 25 | In distribution |
| PXBT162232A | Height.016 in | 10 | In distribution |
| PXBE172534 | Height.017 in | 10 | In distribution |
| XRSFU1818A | Width.018 in | 25 | In distribution |
| XRBF11725 | Width.025 in | 25 | In distribution |
| XRBF3L014 | Outer Diameter.014 in | 25 | In distribution |
| XRBF11722 | Height.017 in | 25 | In distribution |
| PXBD392538 | Height.019 in | 10 | In distribution |
| XRBF218A | Outer Diameter.018 in | 25 | In distribution |
| PXBE172536A | Height.017 in | 10 | In distribution |
| XRBF3L016 | Outer Diameter.016 in | 25 | In distribution |
| PXBE172540 | Height.017 in | 10 | In distribution |
| PXBT162236 | Height.016 in | 10 | In distribution |
| XRALLU1616 | Width.016 in | 25 | In distribution |
| XRBF418 | Outer Diameter.018 in | 25 | In distribution |
| XRSFL1725 | Width.025 in | 25 | In distribution |
| XRBF3U018A | Outer Diameter.018 in | 25 | In distribution |
| PXBD392530A | Height.019 in | 10 | In distribution |
| XRBF51925 | Width.025 in | 25 | In distribution |
| PXBB3192536 | Height.019 in | 10 | In distribution |
| PXBD392524 | Height.019 in | 10 | In distribution |
| PXBD192522 | Width.025 in | 10 | In distribution |
| PXBT192532A | Width.025 in | 10 | In distribution |
| XRBF114 | Outer Diameter.014 in | 25 | In distribution |
| PXBB3192538 | Height.019 in | 10 | In distribution |
| XRBF3L020A | Outer Diameter.020 in | 25 | In distribution |
| XRSFL020A | Outer Diameter.020 in | 25 | In distribution |
| XRBF118A | Outer Diameter.018 in | 25 | In distribution |
| XRBF41722 | Height.017 in | 25 | In distribution |
| PXBT192536 | Height.019 in | 10 | In distribution |
| XRSFL018 | Outer Diameter.018 in | 25 | In distribution |
| PXBE192528A | Width.025 in | 10 | In distribution |
| PXBE192542 | Width.025 in | 10 | In distribution |
| XRBF21725 | Height.017 in | 25 | In distribution |
| XRBF416A | Outer Diameter.016 in | 25 | In distribution |
| PXBB3162242 | Width.022 in | 10 | In distribution |
| PXBT192534 | Height.019 in | 10 | In distribution |
| XRBF21622A | Width.022 in | 25 | In distribution |
| PXBT192528A | Height.019 in | 10 | In distribution |
| XRBF3U1722A | Height.017 in | 25 | In distribution |
| PXBE192530A | Width.025 in | 10 | In distribution |
| PXBB3192528 | Width.025 in | 10 | In distribution |
| XRBF518A | Outer Diameter.018 in | 25 | In distribution |
| PXBE172534A | Height.017 in | 10 | In distribution |
| PXBT162228A | Width.022 in | 10 | In distribution |
| PXBB3162238 | Height.016 in | 10 | In distribution |
| PXBE172528 | Height.017 in | 10 | In distribution |
| PXBB3162242A | Height.016 in | 10 | In distribution |
| XRSFU016A | Outer Diameter.016 in | 25 | In distribution |
| PXBT192524A | Height.019 in | 10 | In distribution |
| XRSFU1825A | Height.018 in | 25 | In distribution |
| PXBD192530 | Height.019 in | 10 | In distribution |
| PXBB3162234 | Height.016 in | 10 | In distribution |
| PXBT192538 | Height.019 in | 10 | In distribution |
| PXBT192538A | Width.025 in | 10 | In distribution |
| XRBF3L2125 | Height.021 in | 25 | In distribution |
| PXBB3162236A | Width.022 in | 10 | In distribution |
| XRBF3U1616 | Width.016 in | 25 | In distribution |
| XRBF216A | Outer Diameter.016 in | 25 | In distribution |
| XRBF11622 | Width.022 in | 25 | In distribution |
| XRBF416 | Outer Diameter.016 in | 25 | In distribution |
| PXBT162226 | Height.016 in | 10 | In distribution |
| XRBF3U014 | Outer Diameter.014 in | 25 | In distribution |
| PXBE172530A | Width.025 in | 10 | In distribution |
| PXBD392528A | Width.025 in | 10 | In distribution |
| PXBB3192534A | Width.025 in | 10 | In distribution |
| XRSFU014A | Outer Diameter.014 in | 25 | In distribution |
| XRBF51725A | Height.017 in | 25 | In distribution |
| PXBD362522A | Height.016 in | 10 | In distribution |
| XRBF3U1725 | Width.025 in | 25 | In distribution |
| XRBF3U016A | Outer Diameter.016 in | 25 | In distribution |
| PXBB3172536 | Width.025 in | 10 | In distribution |
| PXBT162228 | Width.022 in | 10 | In distribution |
| PXBT162238A | Width.022 in | 10 | In distribution |
| XRBF518 | Outer Diameter.018 in | 25 | In distribution |
| XRALLU1717 | Width.017 in | 25 | In distribution |
| XRBF3U1818 | Height.018 in | 25 | In distribution |
| PXBT162240 | Height.016 in | 10 | In distribution |
| PXBD192534 | Width.025 in | 10 | In distribution |
| PXBB3162230A | Width.022 in | 10 | In distribution |
| XRBF3L1722 | Width.022 in | 25 | In distribution |
| PXBD392536A | Width.025 in | 10 | In distribution |
| PXBT192524 | Height.019 in | 10 | In distribution |
| XRALLL1717 | Height.017 in | 25 | In distribution |
| PXBD362536 | Width.025 in | 10 | In distribution |
| PXBT162234A | Width.022 in | 10 | In distribution |
| PXBB3192524A | Height.019 in | 10 | In distribution |
| XRSFL018A | Outer Diameter.018 in | 25 | In distribution |
| XRSFU018A | Outer Diameter.018 in | 25 | In distribution |
| XRBF3U014A | Outer Diameter.014 in | 25 | In distribution |
| XRALLL1722 | Height.017 in | 25 | In distribution |
| XRSFU018 | Outer Diameter.018 in | 25 | In distribution |
| PXBE172538A | Width.025 in | 10 | In distribution |
| XRSFL1722 | Width.022 in | 25 | In distribution |
| XRSFU016 | Outer Diameter.016 in | 25 | In distribution |
| XRBF512A | Outer Diameter.012 in | 25 | In distribution |
| PXBB3172534 | Width.025 in | 10 | In distribution |
| PXBT162242 | Width.022 in | 10 | In distribution |
| XRSFU1622 | Height.016 in | 25 | In distribution |
| XRBF11622A | Width.022 in | 25 | In distribution |
| PXBD362544 | Height.016 in | 10 | In distribution |
| PXBD192538 | Height.019 in | 10 | In distribution |
| PXBT192532 | Width.025 in | 10 | In distribution |
| PXBT162238 | Width.022 in | 10 | In distribution |
| PXBB3162244 | Width.022 in | 10 | In distribution |
| XRSFL2020A | Height.020 in | 25 | In distribution |
| PXBT192540 | Height.019 in | 10 | In distribution |
| XRBF3U1616A | Height.016 in | 25 | In distribution |
| XRBF514A | Outer Diameter.014 in | 25 | In distribution |
| PXBD362528 | Width.025 in | 10 | In distribution |
| PXBB3192536A | Width.025 in | 10 | In distribution |
| PXBB3192526 | Height.019 in | 10 | In distribution |
| XRBF3U1725A | Width.025 in | 25 | In distribution |
| PXBD362528A | Width.025 in | 10 | In distribution |
| PXBT192544 | Width.025 in | 10 | In distribution |
| PXBB3192528A | Width.025 in | 10 | In distribution |
| PXBB3162230 | Height.016 in | 10 | In distribution |
| XRBF41725A | Height.017 in | 25 | In distribution |
| PXBE192526A | Width.025 in | 10 | In distribution |
| PXBD392528A | Height.019 in | 10 | In distribution |
| PXBB3162238A | Height.016 in | 10 | In distribution |
| XRBF11925A | Height.019 in | 25 | In distribution |
| PXBT192542A | Width.025 in | 10 | In distribution |
| PXBB3162234A | Height.016 in | 10 | In distribution |
| XRSFU1925A | Height.019 in | 25 | In distribution |
| XRBF3L1825A | Width.025 in | 25 | In distribution |
| XRSFL014 | Outer Diameter.014 in | 25 | In distribution |
| XRBF41622A | Height.016 in | 25 | In distribution |
| XRBF51616 | Height.016 in | 25 | In distribution |
| XRSFL1925 | Height.019 in | 25 | In distribution |
| PXBT162230 | Height.016 in | 10 | In distribution |
| XRBF41722A | Width.022 in | 25 | In distribution |
| XRSFL1822A | Height.018 in | 25 | In distribution |
| XRBF514 | Outer Diameter.014 in | 25 | In distribution |
| PXBD362538 | Width.025 in | 10 | In distribution |
| XRALLU1722 | Width.022 in | 25 | In distribution |
| XRSFU2020A | Height.020 in | 25 | In distribution |
| XRALLL1822 | Width.022 in | 25 | In distribution |
| PXBD392542A | Height.019 in | 10 | In distribution |
| PXBD392538A | Width.025 in | 10 | In distribution |
| PXBE192542A | Width.025 in | 10 | In distribution |
| PXBB3192534 | Width.025 in | 10 | In distribution |
| PXBT162232 | Height.016 in | 10 | In distribution |
| XRBF51818A | Width.018 in | 25 | In distribution |
| XRSFL020 | Outer Diameter.020 in | 25 | In distribution |
| PXBT162236A | Width.022 in | 10 | In distribution |
| PXBE172526 | Width.025 in | 10 | In distribution |
| PXBB3172536A | Width.025 in | 10 | In distribution |
| PXBE192532A | Height.019 in | 10 | In distribution |
| PXBB3192538A | Width.025 in | 10 | In distribution |
| XRBF51725 | Width.025 in | 25 | In distribution |
| XRBF11725A | Height.017 in | 25 | In distribution |
| PXBD362530A | Width.025 in | 10 | In distribution |
| PXBD362526A | Width.025 in | 10 | In distribution |
| PXBD392526A | Width.025 in | 10 | In distribution |
| PXBD362524A | Height.016 in | 10 | In distribution |
| PXBD362522 | Height.016 in | 10 | In distribution |
| XRSFU2125A | Width.025 in | 25 | In distribution |
| PXBD362534A | Height.016 in | 10 | In distribution |
| PXBE192522 | Width.025 in | 10 | In distribution |
| XRBF3U1622A | Height.016 in | 25 | In distribution |
| XRBF21722 | Height.017 in | 25 | In distribution |
| XRBF3L1725 | Width.025 in | 25 | In distribution |
| XRSFU1822A | Width.022 in | 25 | In distribution |
| XRSFL016 | Outer Diameter.016 in | 25 | In distribution |
| PXBE192536A | Width.025 in | 10 | In distribution |
| XRBF3L1822A | Height.018 in | 25 | In distribution |
| XRBF3U1925 | Height.019 in | 25 | In distribution |
| PXBD362534 | Height.016 in | 10 | In distribution |
| XRBF114A | Outer Diameter.014 in | 25 | In distribution |
| XRBF12020 | Width.020 in | 25 | In distribution |
| PXBE192536 | Height.019 in | 10 | In distribution |
| XRALLL1616 | Width.016 in | 25 | In distribution |
| PXBB3162226A | Width.022 in | 10 | In distribution |
| PXBD392526 | Height.019 in | 10 | In distribution |
| XRSFL1818A | Width.018 in | 25 | In distribution |
| XRBF3U1818A | Width.018 in | 25 | In distribution |
| XRBF51722A | Height.017 in | 25 | In distribution |
| PXBB3192544A | Width.025 in | 10 | In distribution |
| PXBB3192530 | Width.025 in | 10 | In distribution |
| XRBF418A | Outer Diameter.018 in | 25 | In distribution |
| XRSFU1722A | Width.022 in | 25 | In distribution |
| XRBF3U018 | Outer Diameter.018 in | 25 | In distribution |
| PXBD392532A | Height.019 in | 10 | In distribution |
| PXBD392530 | Height.019 in | 10 | In distribution |
| PXBD362544A | Height.016 in | 10 | In distribution |
| XRBF11825A | Height.018 in | 25 | In distribution |
| PXBB3192532A | Height.019 in | 10 | In distribution |
| PXBE192538 | Width.025 in | 10 | In distribution |
| XRBF51622 | Height.016 in | 25 | In distribution |
| XRBF3L018A | Outer Diameter.018 in | 25 | In distribution |
| XRBF516A | Outer Diameter.016 in | 25 | In distribution |
| PXBB3162224 | Height.016 in | 10 | In distribution |
| XRBF3U2125 | Width.025 in | 25 | In distribution |
| PXBD392534A | Height.019 in | 10 | In distribution |
| XRBF51825 | Height.018 in | 25 | In distribution |
| PXBE192540 | Height.019 in | 10 | In distribution |
| PXBD362532A | Height.016 in | 10 | In distribution |
| PXBE192524 | Height.019 in | 10 | In distribution |
| XRSFU1822 | Width.022 in | 25 | In distribution |
| XRBF3U1822 | Height.018 in | 25 | In distribution |
| XRBF12020A | Height.020 in | 25 | In distribution |
| PXBB3162224A | Height.016 in | 10 | In distribution |
| PXBD392522A | Height.019 in | 10 | In distribution |
| PXBD392540A | Width.025 in | 10 | In distribution |
| PXBD392544A | Width.025 in | 10 | In distribution |
| PXBD392528A | Width.025 in | 10 | In distribution |
| XRBF218 | Outer Diameter.018 in | 25 | In distribution |
| PXBD362532 | Width.025 in | 10 | In distribution |
| PXBE192532 | Width.025 in | 10 | In distribution |
| PXBT192522 | Width.025 in | 10 | In distribution |
| XRSFU2020 | Width.020 in | 25 | In distribution |
| XRBF41725 | Height.017 in | 25 | In distribution |
| PXBT192540A | Width.025 in | 10 | In distribution |
| PXBD362536A | Width.025 in | 10 | In distribution |
| PXBB3192530A | Height.019 in | 10 | In distribution |
| PXBB3192540 | Width.025 in | 10 | In distribution |
| XRBF11616A | Width.016 in | 25 | In distribution |
| XRBF3L1616 | Height.016 in | 25 | In distribution |
| XRBF3L1825 | Height.018 in | 25 | In distribution |
| PXBE172524 | Width.025 in | 10 | In distribution |
| PXBT162230A | Width.022 in | 10 | In distribution |
| XRSFL2020 | Width.020 in | 25 | In distribution |
| XRSFU020A | Outer Diameter.020 in | 25 | In distribution |
| XRBF3L016A | Outer Diameter.016 in | 25 | In distribution |
| PXBD362534A | Width.025 in | 10 | In distribution |
| XRSFU1622A | Height.016 in | 25 | In distribution |
| XRSFL1622 | Width.022 in | 25 | In distribution |
| PXBD362542A | Height.016 in | 10 | 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.