Ultraesthetic Europa Solo-Pack
SE NITI EUROPA II UPR 017x025 TOOTH SOLO-PACK
43manufacturers in China registered for this device type
55catalogue 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 | Height 0.016 to 0.021 in; width 0.018 to 0.025 in; outer diameter 0.012 to 0.02 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEEFL012TS | Outer Diameter.012 in | In distribution |
| SSEFL1622TS | Height.016 in | In distribution |
| SSEFU3725TS | Width.025 in | In distribution |
| SEEFU3725TS | Width.025 in | In distribution |
| SSEFU3925TS | Width.025 in | In distribution |
| SSEFL020TS | Outer Diameter.020 in | In distribution |
| SSEFU1725TS | Width.025 in | In distribution |
| SSEFL1725TS | Height.017 in | In distribution |
| SEEFL2125TS | Height.021 in | In distribution |
| SEEFL020TS | Outer Diameter.020 in | In distribution |
| SEEFU118TS | Outer Diameter.018 in | In distribution |
| SEEFU3622TS | Height.016 in | In distribution |
| SEEFU2020TS | Width.020 in | In distribution |
| SEEFU016TS | Outer Diameter.016 in | In distribution |
| SSEFU2125TS | Height.021 in | In distribution |
| SEEFU3925TS | Width.025 in | In distribution |
| SEEFU2125TS | Height.021 in | In distribution |
| SEEFU1825TS | Width.025 in | In distribution |
| SSEFU1825TS | Width.025 in | In distribution |
| SEEFU012TS | Outer Diameter.012 in | In distribution |
| SEEFL1622TS | Width.022 in | In distribution |
| SSEFU1925TS | Width.025 in | In distribution |
| SSEFU2020TS | Height.020 in | In distribution |
| SEEFU020TS | Outer Diameter.020 in | In distribution |
| SEEFU116TS | Outer Diameter.016 in | In distribution |
| SSEFL018TS | Outer Diameter.018 in | In distribution |
| SEEFU018TS | Outer Diameter.018 in | In distribution |
| SEEFL016TS | Outer Diameter.016 in | In distribution |
| SEEFU014TS | Outer Diameter.014 in | In distribution |
| SSEFL016TS | Outer Diameter.016 in | In distribution |
| SSEFU118TS | Outer Diameter.018 in | In distribution |
| SSEFL2125TS | Width.025 in | In distribution |
| SEEFU1622TS | Height.016 in | In distribution |
| SEEFU3020TS | Height.020 in | In distribution |
| SSEFU120TS | Outer Diameter.020 in | In distribution |
| SEEFL018TS | Outer Diameter.018 in | In distribution |
| SSEFL014TS | Outer Diameter.014 in | In distribution |
| SSEFU016TS | Outer Diameter.016 in | In distribution |
| SEEFL1925TS | Width.025 in | In distribution |
| SSEFL120TS | Outer Diameter.020 in | In distribution |
| SEEFL1725TS | Height.017 in | In distribution |
| SSEFL1825TS | Height.018 in | In distribution |
| SEEFU114TS | Outer Diameter.014 in | In distribution |
| SSEFU020TS | Outer Diameter.020 in | In distribution |
| SSEFU018TS | Outer Diameter.018 in | In distribution |
| SSEFL1925TS | Width.025 in | In distribution |
| SEEFL014TS | Outer Diameter.014 in | In distribution |
| SEEFU1725TS | Height.017 in | In distribution |
| SSEFU1622TS | Height.016 in | In distribution |
| SEEFL2020TS | Width.020 in | In distribution |
| SEEFU1818TS | Width.018 in | In distribution |
| SEEFL1825TS | Width.025 in | In distribution |
| SSEFU014TS | Outer Diameter.014 in | In distribution |
| SEEFU1925TS | Width.025 in | In distribution |
| SEEFL1818TS | Height.018 in | 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.