Solo-Pack
Superelastic NiTi, .016x.022 (,41mm x ,56mm), Lower, Reverse Curve I, Aesthetic, Solo-Pack
43manufacturers in China registered for this device type
498catalogue 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 0.01 to 0.02 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSBF3U018AS | Outer Diameter.018 in | In distribution |
| SSBF3L1925S | Height.019 in | In distribution |
| SELLL013S | Outer Diameter.013 in | In distribution |
| SEOFBU2020S | Height.020 in | In distribution |
| TLMU1622AS | Height.016 in | In distribution |
| SSBF3L014AES | Outer Diameter.014 in | In distribution |
| SERCU1825S | Height.018 in | In distribution |
| SEBF3L016AS | Outer Diameter.016 in | In distribution |
| SESFU014AS | Outer Diameter.014 in | In distribution |
| CSFL8725S | Height.017 in | In distribution |
| SEBF3L012DS | Outer Diameter.012 in | In distribution |
| SELSU010AS | Outer Diameter.010 in | In distribution |
| SELLUN014AS | Outer Diameter.014 in | In distribution |
| SSSFL016GS | Outer Diameter.016 in | In distribution |
| SSSFL1725S | Width.025 in | In distribution |
| SERCU016AES | Outer Diameter.016 in | In distribution |
| SERCU31925S | Width.025 in | In distribution |
| SERCL012AS | Outer Diameter.012 in | In distribution |
| SEBF3U012AS | Outer Diameter.012 in | In distribution |
| SESFU1616AS | Height.016 in | In distribution |
| SEBF3L020S | Outer Diameter.020 in | In distribution |
| SESFL016S | Outer Diameter.016 in | In distribution |
| SESFL012AS | Outer Diameter.012 in | In distribution |
| SERCL1622AES | Width.022 in | In distribution |
| TLLU016S | Outer Diameter.016 in | In distribution |
| TBF3U014AS | Outer Diameter.014 in | In distribution |
| SELML016S | Outer Diameter.016 in | In distribution |
| SSL1622AS | Width.022 in | In distribution |
| SSBF3L1725S | Height.017 in | In distribution |
| SERCU1622AS | Width.022 in | In distribution |
| SELSL013S | Outer Diameter.013 in | In distribution |
| SERCL016AS | Outer Diameter.016 in | In distribution |
| SEBF3L1925AS | Width.025 in | In distribution |
| SEMLUN012S | Outer Diameter.012 in | In distribution |
| TLML1717AS | Width.017 in | In distribution |
| SEBF3U016S | Outer Diameter.016 in | In distribution |
| SEOFTL1818AS | Width.018 in | In distribution |
| SSBF3U1616S | Width.016 in | In distribution |
| SEBF3U1616S | Height.016 in | In distribution |
| SELSL010S | Outer Diameter.010 in | In distribution |
| SELSU016S | Outer Diameter.016 in | In distribution |
| SSSFL1925S | Width.025 in | In distribution |
| SEBF3L012AS | Outer Diameter.012 in | In distribution |
| SSBF3U1622AES | Width.022 in | In distribution |
| SSSFL1825S | Width.025 in | In distribution |
| SERCU1616S | Height.016 in | In distribution |
| SEOFBL1616S | Height.016 in | In distribution |
| SSBF3L1925AS | Height.019 in | In distribution |
| TBF3U012AS | Outer Diameter.012 in | In distribution |
| TBF3U016S | Outer Diameter.016 in | In distribution |
| SELSU013AS | Outer Diameter.013 in | In distribution |
| TLLU016AS | Outer Diameter.016 in | In distribution |
| SSBF3L020AS | Outer Diameter.020 in | In distribution |
| SEOFBL1825AS | Height.018 in | In distribution |
| SSBF11925S | Width.025 in | In distribution |
| TBF3L1825AS | Width.025 in | In distribution |
| SEOFBL2020S | Height.020 in | In distribution |
| SELML010AS | Outer Diameter.010 in | In distribution |
| SERCL020S | Outer Diameter.020 in | In distribution |
| SESFL014S | Outer Diameter.014 in | In distribution |
| SSBF3L018S | Outer Diameter.018 in | In distribution |
| SSBF3U016S | Outer Diameter.016 in | In distribution |
| SEBF3L1825S | Width.025 in | In distribution |
| SSBF3L020S | Outer Diameter.020 in | In distribution |
| SEBF51616S | Height.016 in | In distribution |
| SEOFTL1825AS | Width.025 in | In distribution |
| SSSFL018GS | Outer Diameter.018 in | In distribution |
| SESFU018S | Outer Diameter.018 in | In distribution |
| SEBF3L2125AS | Width.025 in | In distribution |
| SEOFTU016S | Outer Diameter.016 in | In distribution |
| TBF3U1622S | Height.016 in | In distribution |
| SESFL1616AS | Width.016 in | In distribution |
| SEBF51616AS | Width.016 in | In distribution |
| TLSL1717S | Height.017 in | In distribution |
| TLMU1622S | Height.016 in | In distribution |
| TLMU016S | Outer Diameter.016 in | In distribution |
| SELSU013S | Outer Diameter.013 in | In distribution |
| SEBF3U1825AS | Width.025 in | In distribution |
| SERCU31622AS | Height.016 in | In distribution |
| SEBF3U1825S | Height.018 in | In distribution |
| SELLU016AS | Outer Diameter.016 in | In distribution |
| SSSFL1725GS | Height.017 in | In distribution |
| SSBF3L1725AES | Width.025 in | In distribution |
| TBF3U1925AS | Height.019 in | In distribution |
| TBF3L016S | Outer Diameter.016 in | In distribution |
| SSSFU016S | Outer Diameter.016 in | In distribution |
| SERCL1616AS | Height.016 in | In distribution |
| SEBF3U016AES | Outer Diameter.016 in | In distribution |
| SEBF3L020AES | Outer Diameter.020 in | In distribution |
| SERCU014S | Outer Diameter.014 in | In distribution |
| SELLU016S | Outer Diameter.016 in | In distribution |
| SELLL016S | Outer Diameter.016 in | In distribution |
| SSBF3L1825AS | Height.018 in | In distribution |
| SSSFU1616AS | Height.016 in | In distribution |
| SESFU020S | Outer Diameter.020 in | In distribution |
| CSFU8825S | Width.025 in | In distribution |
| SEMLUN016AS | Outer Diameter.016 in | In distribution |
| TBF3U018AS | Outer Diameter.018 in | In distribution |
| TLSL1717AS | Width.017 in | In distribution |
| SEOFTU1616S | Height.016 in | In distribution |
| CSFU8622S | Width.022 in | In distribution |
| TBF3L018AS | Outer Diameter.018 in | In distribution |
| SEOFTU2125S | Width.025 in | In distribution |
| SEBF3U012AES | Outer Diameter.012 in | In distribution |
| SSBF3L018AS | Outer Diameter.018 in | In distribution |
| SEBF3L1925AES | Width.025 in | In distribution |
| TLML016S | Outer Diameter.016 in | In distribution |
| TLMU016AS | Outer Diameter.016 in | In distribution |
| SSBF11622AS | Height.016 in | In distribution |
| SERCL3018DS | Outer Diameter.018 in | In distribution |
| SERCU020AS | Outer Diameter.020 in | In distribution |
| SEOFTL1925AS | Height.019 in | In distribution |
| SEBF3U1622AS | Width.022 in | In distribution |
| SESFU1725AS | Width.025 in | In distribution |
| CSFL8622AS | Width.022 in | In distribution |
| SEBF3U014S | Outer Diameter.014 in | In distribution |
| SEBF3U1925AS | Height.019 in | In distribution |
| SEOFBL1622AS | Height.016 in | In distribution |
| CSFL8622S | Width.022 in | In distribution |
| SEBF3U018AS | Outer Diameter.018 in | In distribution |
| SSBF3L1616S | Height.016 in | In distribution |
| SEBF3U1925AES | Height.019 in | In distribution |
| SERCU020S | Outer Diameter.020 in | In distribution |
| SSSFU1825AS | Width.025 in | In distribution |
| SEBF3U014AS | Outer Diameter.014 in | In distribution |
| SSSFL012S | Outer Diameter.012 in | In distribution |
| SESFL1622AS | Height.016 in | In distribution |
| SESFL012S | Outer Diameter.012 in | In distribution |
| SEBF3U1616AS | Height.016 in | In distribution |
| SELSL016S | Outer Diameter.016 in | In distribution |
| SESFU1825S | Width.025 in | In distribution |
| CSFU8622AS | Height.016 in | In distribution |
| SEOFTL1825S | Width.025 in | In distribution |
| SSBF3U1822S | Width.022 in | In distribution |
| SEMLUN014S | Outer Diameter.014 in | In distribution |
| TBF3L2020AS | Width.020 in | In distribution |
| SSSFU1622S | Height.016 in | In distribution |
| SESFL020S | Outer Diameter.020 in | In distribution |
| CSFU8616AS | Height.016 in | In distribution |
| SERCU1622DS | Height.016 in | In distribution |
| TLLU1622AS | Width.022 in | In distribution |
| TBF3L014S | Outer Diameter.014 in | In distribution |
| TLLL016S | Outer Diameter.016 in | In distribution |
| CSFU8725AS | Height.017 in | In distribution |
| SERCL31925AS | Width.025 in | In distribution |
| SERCL1825AS | Width.025 in | In distribution |
| SELSL016AS | Outer Diameter.016 in | In distribution |
| SERCU012S | Outer Diameter.012 in | In distribution |
| SESFL1622S | Width.022 in | In distribution |
| SEOFTU2020AS | Height.020 in | In distribution |
| SSSFU1925AS | Height.019 in | In distribution |
| SERCU1622ADS | Width.022 in | In distribution |
| SEBF3U1622AES | Height.016 in | In distribution |
| SERCU016AS | Outer Diameter.016 in | In distribution |
| SSSFU1622AS | Width.022 in | In distribution |
| SSBF3U1818AES | Width.018 in | In distribution |
| SESFL1825S | Width.025 in | In distribution |
| CSFU8616S | Height.016 in | In distribution |
| TBF3L1616AS | Width.016 in | In distribution |
| SERCU016S | Outer Diameter.016 in | In distribution |
| SERCU3018AS | Outer Diameter.018 in | In distribution |
| SEBF3L1622AS | Width.022 in | In distribution |
| SEBF3U1725AS | Width.025 in | In distribution |
| SELMU010AS | Outer Diameter.010 in | In distribution |
| SSSFL020S | Outer Diameter.020 in | In distribution |
| TLSL1622S | Height.016 in | In distribution |
| SERCL020AS | Outer Diameter.020 in | In distribution |
| SSBF3L1825AES | Width.025 in | In distribution |
| SEOFBL1825S | Width.025 in | In distribution |
| TLSU1622S | Width.022 in | In distribution |
| TBF3U1725AS | Width.025 in | In distribution |
| SSSFU020S | Outer Diameter.020 in | In distribution |
| SEOFTU2125AS | Width.025 in | In distribution |
| SSBF3U1925S | Height.019 in | In distribution |
| SEOFTL1725S | Height.017 in | In distribution |
| SSSFU016AS | Outer Diameter.016 in | In distribution |
| SEOFBL1622S | Height.016 in | In distribution |
| TBF3L012S | Outer Diameter.012 in | In distribution |
| TLML1717S | Height.017 in | In distribution |
| SSBF3U016AS | Outer Diameter.016 in | In distribution |
| SEOFBU1825S | Width.025 in | In distribution |
| TBF3U1925S | Height.019 in | In distribution |
| SSSFU1725AS | Width.025 in | In distribution |
| SELML013S | Outer Diameter.013 in | In distribution |
| SSBF3L1825S | Height.018 in | In distribution |
| SEBF3L1925S | Width.025 in | In distribution |
| SEBF3U1925S | Height.019 in | In distribution |
| SEOFBL1616AS | Width.016 in | In distribution |
| SERCL31622S | Width.022 in | In distribution |
| SSBF3L1622GS | Height.016 in | In distribution |
| TLLL1622AS | Height.016 in | In distribution |
| SSSFL018S | Outer Diameter.018 in | In distribution |
| SELLL013AS | Outer Diameter.013 in | In distribution |
| SEBF3L014S | Outer Diameter.014 in | In distribution |
| SEBF3L1825AES | Height.018 in | In distribution |
| SERCL31622AS | Height.016 in | In distribution |
| SERCL1725S | Width.025 in | In distribution |
| SELMU013AS | Outer Diameter.013 in | In distribution |
| SSL016AS | Outer Diameter.016 in | In distribution |
| TLSU016AS | Outer Diameter.016 in | In distribution |
| SERCL1825S | Height.018 in | In distribution |
| SELSU010S | Outer Diameter.010 in | In distribution |
| SELLL010AS | Outer Diameter.010 in | In distribution |
| SESFL016AS | Outer Diameter.016 in | In distribution |
| SEOFTU1818AS | Height.018 in | In distribution |
| SESFU012AS | Outer Diameter.012 in | In distribution |
| TLLL1717AS | Height.017 in | In distribution |
| SSBF3L014S | Outer Diameter.014 in | In distribution |
| SESFU1616S | Width.016 in | In distribution |
| CSFU8725S | Width.025 in | In distribution |
| SESFL014AS | Outer Diameter.014 in | In distribution |
| SERCU1825AS | Height.018 in | In distribution |
| TLSL016AS | Outer Diameter.016 in | In distribution |
| TLMU1725S | Height.017 in | In distribution |
| SESFU2125S | Height.021 in | In distribution |
| SESFU1925S | Height.019 in | In distribution |
| SSSFU020GS | Outer Diameter.020 in | In distribution |
| SSSFU1622GAS | Width.022 in | In distribution |
| SSBF3L2125S | Width.025 in | In distribution |
| SEBF3L020AS | Outer Diameter.020 in | In distribution |
| SSSFU1725S | Height.017 in | In distribution |
| SERCU1725S | Width.025 in | In distribution |
| SEOFTU1725AS | Width.025 in | In distribution |
| SERCU1622S | Height.016 in | In distribution |
| SSBF3L1616GS | Height.016 in | In distribution |
| TBF3L1925AS | Width.025 in | In distribution |
| TLLL1717S | Height.017 in | In distribution |
| SEOFTL1925S | Height.019 in | In distribution |
| SESFU016S | Outer Diameter.016 in | In distribution |
| SSSFU018AS | Outer Diameter.018 in | In distribution |
| TBF3L016AS | Outer Diameter.016 in | In distribution |
| TBF3U1616S | Width.016 in | In distribution |
| CSFL8616S | Width.016 in | In distribution |
| TBF3L1725AS | Width.025 in | In distribution |
| SEBF3L016S | Outer Diameter.016 in | In distribution |
| TLLL016AS | Outer Diameter.016 in | In distribution |
| SSBF3U014AS | Outer Diameter.014 in | In distribution |
| SSSFL018AS | Outer Diameter.018 in | In distribution |
| SEOFBU1925AS | Height.019 in | In distribution |
| SSBF3U1825AES | Width.025 in | In distribution |
| SELLL010S | Outer Diameter.010 in | In distribution |
| SEOFTU1725S | Width.025 in | In distribution |
| SERCU018AS | Outer Diameter.018 in | In distribution |
| SELLUN012AS | Outer Diameter.012 in | In distribution |
| SEBF3U1725AES | Width.025 in | In distribution |
| SSSFU018GS | Outer Diameter.018 in | In distribution |
| SEBF3U018AES | Outer Diameter.018 in | In distribution |
| SESFL2125AS | Width.025 in | In distribution |
| SESFL1725S | Height.017 in | In distribution |
| SELLU010S | Outer Diameter.010 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.