Proclinic
ARCO NITI SUPERELESTICO ESTETICO OVOIDE INF .018" x .025"
43manufacturers in China registered for this device type
501catalogue 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 0.014 to 0.021 in; outer diameter 0.012 to 0.051 in; length 14 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| L0619 | Outer Diameter.014 in | 10 | In distribution |
| L0718 | Width.022 in | 10 | In distribution |
| L9916 | Outer Diameter.014 in | 25 | In distribution |
| L6264 | Outer Diameter.014 in | 25 | In distribution |
| L0849 | Width.025 in | 25 | In distribution |
| L0681 | Width.022 in | 10 | In distribution |
| L0788 | Height.016 in | 25 | In distribution |
| L0591 | Height.021 in | 25 | In distribution |
| L0702 | Height.019 in | 10 | In distribution |
| L0518 | Width.018 in | 10 | In distribution |
| L0592 | Width.025 in | 25 | In distribution |
| L0542 | Height.018 in | 10 | In distribution |
| L0705 | Width.025 in | 10 | In distribution |
| L6276 | Height.018 in | 25 | In distribution |
| L3262 | Width.025 in | 25 | In distribution |
| L0792 | Length 14 in | 25 | In distribution |
| L5158 | Height.017 in | 25 | In distribution |
| L9965 | Height.014 in | 25 | In distribution |
| L0815 | 100 | In distribution | |
| L0520 | Height.018 in | 10 | In distribution |
| L9943 | Width.025 in | 25 | In distribution |
| L0669 | Height.016 in | 10 | In distribution |
| L0512 | Width.016 in | 25 | In distribution |
| L9932 | Width.025 in | 25 | In distribution |
| L0544 | Width.025 in | 10 | In distribution |
| L0764 | Height.017 in | 10 | In distribution |
| L0675 | Width.025 in | 25 | In distribution |
| L3043 | Outer Diameter.014 in | 25 | In distribution |
| L5157 | Height.016 in | 25 | In distribution |
| L6257 | Height.017 in | 10 | In distribution |
| L5147 | Outer Diameter.018 in | 25 | In distribution |
| L9927 | Height.016 in | 25 | In distribution |
| L9946 | Width.025 in | 25 | In distribution |
| L0758 | Width.022 in | 10 | In distribution |
| L0607 | Width.025 in | 10 | In distribution |
| L3063 | Width.025 in | 25 | In distribution |
| L0510 | Outer Diameter.020 in | 10 | In distribution |
| L0671 | Height.017 in | 10 | In distribution |
| L0769 | Height.019 in | 10 | In distribution |
| L3069 | Outer Diameter.036 in | 25 | In distribution |
| L9949 | Outer Diameter.018 in | 25 | In distribution |
| L0762 | Width.025 in | 10 | In distribution |
| L0552 | Outer Diameter.016 in | 10 | In distribution |
| L32622 | Height.017 in | 25 | In distribution |
| L5149 | Outer Diameter.020 in | 25 | In distribution |
| L0972 | Width.025 in | 25 | In distribution |
| L0625 | Outer Diameter.020 in | 10 | In distribution |
| L6281 | Height.021 in | 25 | In distribution |
| L0521 | Width.025 in | 10 | In distribution |
| L5152 | Height.016 in | 25 | In distribution |
| L3068 | Length 14 in | 25 | In distribution |
| L3254 | Outer Diameter.018 in | 25 | In distribution |
| L0528 | Outer Diameter.014 in | 10 | In distribution |
| L0623 | Outer Diameter.018 in | 10 | In distribution |
| L0717 | Width.022 in | 10 | In distribution |
| L0606 | Width.022 in | 10 | In distribution |
| L3056 | Height.016 in | 25 | In distribution |
| L6271 | Outer Diameter.020 in | 25 | In distribution |
| L0781 | Outer Diameter.018 in | 25 | In distribution |
| L0965 | Width.025 in | 25 | In distribution |
| L0596 | Outer Diameter.014 in | 25 | In distribution |
| L0751 | Height.016 in | 10 | In distribution |
| L0760 | Height.017 in | 10 | In distribution |
| L0657 | Height.019 in | 10 | In distribution |
| L0772 | Width.025 in | 10 | In distribution |
| L5145 | Outer Diameter.016 in | 25 | In distribution |
| L5150 | Height.014 in | 25 | In distribution |
| L0791 | Length 14 in | 25 | In distribution |
| L3062 | Height.018 in | 25 | In distribution |
| L9967 | Height.016 in | 25 | In distribution |
| L0545 | Width.025 in | 10 | In distribution |
| L0765 | Height.017 in | 10 | In distribution |
| L0548 | Outer Diameter.012 in | 10 | In distribution |
| L0564 | Width.025 in | 10 | In distribution |
| L0844 | Height.016 in | 25 | In distribution |
| L0848 | Height.017 in | 25 | In distribution |
| L0561 | Width.025 in | 10 | In distribution |
| L0526 | Outer Diameter.012 in | 10 | In distribution |
| L0737 | Height.019 in | 10 | In distribution |
| L0766 | Height.017 in | 10 | In distribution |
| L9953 | Height.016 in | 25 | In distribution |
| L3072 | Height.016 in | 25 | In distribution |
| L0513 | Width.022 in | 25 | In distribution |
| L0731 | Height.017 in | 10 | In distribution |
| L5159 | Width.025 in | 25 | In distribution |
| L6263 | Height.021 in | 10 | In distribution |
| L5163 | Height.018 in | 25 | In distribution |
| L0569 | Outer Diameter.012 in | 25 | In distribution |
| L0680 | Width.022 in | 10 | In distribution |
| L0754 | Height.016 in | 10 | In distribution |
| L0729 | Width.025 in | 10 | In distribution |
| L0556 | Outer Diameter.020 in | 10 | In distribution |
| L0715 | Height.016 in | 10 | In distribution |
| L0784 | Length 14 in | 25 | In distribution |
| L0688 | Width.025 in | 10 | In distribution |
| L3257 | Width.025 in | 25 | In distribution |
| L0676 | Width.025 in | 25 | In distribution |
| L0630 | Height.016 in | 10 | In distribution |
| L1123 | Outer Diameter.014 in | 25 | In distribution |
| L0583 | Width.025 in | 25 | In distribution |
| L9923 | Outer Diameter.018 in | 25 | In distribution |
| L0633 | Height.018 in | 10 | In distribution |
| L0971 | Height.019 in | 25 | In distribution |
| L9926 | Height.016 in | 25 | In distribution |
| L0797 | Length 14 in | 25 | In distribution |
| L6280 | Height.021 in | 25 | In distribution |
| L5148 | Outer Diameter.020 in | 25 | In distribution |
| L9928 | Height.016 in | 25 | In distribution |
| L0610 | Height.018 in | 10 | In distribution |
| L3073 | Height.017 in | 25 | In distribution |
| L0956 | Outer Diameter.020 in | 25 | In distribution |
| L0722 | Height.016 in | 10 | In distribution |
| L9934 | Height.020 in | 25 | In distribution |
| L6253 | Outer Diameter.020 in | 10 | In distribution |
| L9948 | Outer Diameter.016 in | 25 | In distribution |
| L0953 | Outer Diameter.018 in | 25 | In distribution |
| L0684 | Height.016 in | 10 | In distribution |
| L9944 | Height.019 in | 25 | In distribution |
| L0961 | Width.022 in | 25 | In distribution |
| L5166 | Height.020 in | 25 | In distribution |
| L0960 | Width.016 in | 25 | In distribution |
| L0546 | Width.025 in | 10 | In distribution |
| L0954 | Outer Diameter.018 in | 25 | In distribution |
| L0536 | Height.016 in | 10 | In distribution |
| L0756 | Height.016 in | 10 | In distribution |
| L0716 | Height.016 in | 10 | In distribution |
| L3259 | Height.016 in | 25 | In distribution |
| L6284 | 1,000 | In distribution | |
| L0725 | Width.025 in | 10 | In distribution |
| L1132 | Height.021 in | 25 | In distribution |
| L6254 | Width.022 in | 10 | In distribution |
| L9960 | Outer Diameter.012 in | 25 | In distribution |
| L0948 | Outer Diameter.012 in | 25 | In distribution |
| L3042 | Outer Diameter.014 in | 25 | In distribution |
| L0845 | Height.016 in | 25 | In distribution |
| L9957 | Height.018 in | 25 | In distribution |
| L0541 | Height.018 in | 10 | In distribution |
| L9511 | Width.022 in | 10 | In distribution |
| L0639 | Width.025 in | 10 | In distribution |
| L0796 | Length 14 in | 25 | In distribution |
| L0964 | Height.016 in | 25 | In distribution |
| L0640 | Height.021 in | 10 | In distribution |
| L0793 | Height.021 in | 25 | In distribution |
| L3044 | Outer Diameter.016 in | 25 | In distribution |
| L0668 | Height.016 in | 10 | In distribution |
| L0753 | Height.016 in | 10 | In distribution |
| L0605 | Height.016 in | 10 | In distribution |
| L9936 | Width.025 in | 25 | In distribution |
| L0559 | Width.022 in | 10 | In distribution |
| L0790 | Width.025 in | 25 | In distribution |
| L0530 | Outer Diameter.016 in | 10 | In distribution |
| L0963 | Width.025 in | 25 | In distribution |
| L0740 | Width.025 in | 10 | In distribution |
| L3066 | Height.021 in | 25 | In distribution |
| L0501 | Outer Diameter.012 in | 25 | In distribution |
| L6279 | Width.025 in | 25 | In distribution |
| L6255 | Width.022 in | 10 | In distribution |
| L5169 | Width.025 in | 25 | In distribution |
| L9952 | Height.016 in | 25 | In distribution |
| L0779 | Outer Diameter.014 in | 25 | In distribution |
| L6262 | Width.025 in | 10 | In distribution |
| L0800 | Length 14 in | 25 | In distribution |
| L3048 | Outer Diameter.020 in | 25 | In distribution |
| L9970 | Height.017 in | 25 | In distribution |
| L0563 | Height.018 in | 10 | In distribution |
| L0626 | Outer Diameter.020 in | 10 | In distribution |
| L0841 | Outer Diameter.018 in | 25 | In distribution |
| L3059 | Height.017 in | 25 | In distribution |
| L6285 | 1,000 | In distribution | |
| L0719 | Height.016 in | 10 | In distribution |
| L0738 | Width.025 in | 10 | In distribution |
| L0525 | Outer Diameter.012 in | 10 | In distribution |
| L0735 | Width.025 in | 10 | In distribution |
| L0847 | Width.022 in | 25 | In distribution |
| L0836 | Outer Diameter.014 in | 25 | In distribution |
| L6247 | Outer Diameter.014 in | 10 | In distribution |
| L0683 | Height.016 in | 10 | In distribution |
| L0576 | Outer Diameter.018 in | 100 | In distribution |
| L0967 | Width.018 in | 25 | In distribution |
| L6252 | Outer Diameter.020 in | 10 | In distribution |
| L0553 | Outer Diameter.018 in | 10 | In distribution |
| L0533 | Outer Diameter.020 in | 10 | In distribution |
| L0523 | Width.025 in | 25 | In distribution |
| L6277 | Height.018 in | 25 | In distribution |
| L6249 | Outer Diameter.016 in | 10 | In distribution |
| L0773 | Height.019 in | 10 | In distribution |
| L5154 | Width.022 in | 25 | In distribution |
| L9935 | Height.021 in | 25 | In distribution |
| L0966 | Height.017 in | 25 | In distribution |
| L0834 | Outer Diameter.012 in | 25 | In distribution |
| L0692 | Height.017 in | 10 | In distribution |
| L9921 | Outer Diameter.014 in | 25 | In distribution |
| L6248 | Outer Diameter.016 in | 10 | In distribution |
| L3251 | Outer Diameter.014 in | 25 | In distribution |
| L0579 | Height.016 in | 25 | In distribution |
| L3065 | Height.019 in | 25 | In distribution |
| L0505 | Outer Diameter.016 in | 10 | In distribution |
| L9950 | Outer Diameter.020 in | 25 | In distribution |
| L0787 | Outer Diameter.040 in | 25 | In distribution |
| L9955 | Height.017 in | 25 | In distribution |
| L0629 | Width.022 in | 10 | In distribution |
| L3040 | Outer Diameter.012 in | 25 | In distribution |
| L9962 | Outer Diameter.016 in | 25 | In distribution |
| L0551 | Outer Diameter.016 in | 10 | In distribution |
| L6274 | Height.017 in | 25 | In distribution |
| L0574 | Outer Diameter.016 in | 25 | In distribution |
| L0627 | Height.016 in | 10 | In distribution |
| L0703 | Width.025 in | 10 | In distribution |
| L3061 | Width.018 in | 25 | In distribution |
| L3260 | Width.025 in | 25 | In distribution |
| L0653 | Height.017 in | 10 | In distribution |
| L0696 | Height.017 in | 10 | In distribution |
| L5165 | Height.019 in | 25 | In distribution |
| L0535 | Width.016 in | 10 | In distribution |
| L9954 | Height.016 in | 25 | In distribution |
| L1126 | Length 14 in | 25 | In distribution |
| L0543 | Width.025 in | 10 | In distribution |
| L0678 | Height.021 in | 25 | In distribution |
| L1131 | Length 14 in | 25 | In distribution |
| L6269 | Outer Diameter.018 in | 25 | In distribution |
| L0774 | Width.025 in | 10 | In distribution |
| L0755 | Width.022 in | 10 | In distribution |
| L0955 | Outer Diameter.020 in | 25 | In distribution |
| L0601 | Outer Diameter.020 in | 10 | In distribution |
| L0685 | Width.022 in | 10 | In distribution |
| L0704 | Width.025 in | 10 | In distribution |
| L0843 | Outer Diameter.020 in | 25 | In distribution |
| L0789 | Height.016 in | 25 | In distribution |
| L9973 | Width.025 in | 25 | In distribution |
| L9971 | Width.018 in | 25 | In distribution |
| L3252 | Outer Diameter.016 in | 25 | In distribution |
| L0620 | Outer Diameter.014 in | 10 | In distribution |
| L9938 | Width.022 in | 25 | In distribution |
| L3050 | Height.014 in | 25 | In distribution |
| L3045 | Outer Diameter.016 in | 25 | In distribution |
| L3058 | Height.017 in | 25 | In distribution |
| L3070 | Length 14 in | 25 | In distribution |
| L0517 | Height.018 in | 10 | In distribution |
| L0516 | Width.025 in | 25 | In distribution |
| L0726 | Height.017 in | 10 | In distribution |
| L0776 | Height.019 in | 10 | In distribution |
| L0624 | Outer Diameter.018 in | 10 | In distribution |
| L3053 | Width.016 in | 25 | In distribution |
| L9959 | Width.020 in | 25 | In distribution |
| L0839 | Outer Diameter.016 in | 25 | In distribution |
| L0634 | Width.018 in | 10 | In distribution |
| L5168 | Height.021 in | 25 | In distribution |
| L0588 | Height.018 in | 25 | In distribution |
| L0699 | Width.025 in | 10 | In distribution |
| L0838 | Outer Diameter.016 in | 25 | 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.