Alpha-Wires
Orthodontic Stainless steel archwire U 0.012": orthodontic Stainless steel Archwires size 0.012" Upper, round, 10 pcs/pk
43manufacturers in China registered for this device type
142catalogue numbers in this listing
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 | Ortho Pro Dent LLC, United States |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2024-11-03 |
| Record revised | 2024-11-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature up to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 610-030-09 | In distribution | |
| 602-175-3S | In distribution | |
| 602-04 | In distribution | |
| 610-036-21 | In distribution | |
| 615-KS-14 | In distribution | |
| 602-05 | In distribution | |
| 601-08T | In distribution | |
| 610-045-07 | In distribution | |
| 601-03C | In distribution | |
| 602-15-8S | In distribution | |
| 601-08C | In distribution | |
| 601-16 | In distribution | |
| 615-PS-14 | In distribution | |
| 620-B28 | In distribution | |
| 601-12T | In distribution | |
| 612-045-09 | In distribution | |
| 601-04T” | In distribution | |
| 601-12C | In distribution | |
| 610-030-06 | In distribution | |
| 615-PL-10 | In distribution | |
| 615-PS-10 | In distribution | |
| 612-045-07 | In distribution | |
| 601-12 | In distribution | |
| 601-02C | In distribution | |
| 610-045-06 | In distribution | |
| 610-045-15 | In distribution | |
| 601-11T | In distribution | |
| 612-045-21 | In distribution | |
| 602-01 | In distribution | |
| 612-030-06 | In distribution | |
| 610-036-09 | In distribution | |
| 612-036-09 | In distribution | |
| 601-19C | In distribution | |
| 602-19-8S | In distribution | |
| 602-155-3S | In distribution | |
| 602-06 | In distribution | |
| 601-22T | In distribution | |
| 602-08 | In distribution | |
| 612-030-07 | In distribution | |
| 620-B36 | In distribution | |
| 602-22 | In distribution | |
| 610-036-06 | In distribution | |
| 601-06T | In distribution | |
| 601-07T | In distribution | |
| 612-036-07 | In distribution | |
| 601-15 | In distribution | |
| 612-030-09 | In distribution | |
| 602-07 | In distribution | |
| 612-045-06 | In distribution | |
| 602-13-8S | In distribution | |
| 601-46T | In distribution | |
| 601-06 | In distribution | |
| 601-14C | In distribution | |
| 601-05 | In distribution | |
| 602-03 | In distribution | |
| 601-09T | In distribution | |
| 602-02 | In distribution | |
| 601-16T | In distribution | |
| 602-16 | In distribution | |
| 615-KL-10 | In distribution | |
| 610-036-15 | In distribution | |
| 612-036-06 | In distribution | |
| 601-13T | In distribution | |
| 602-12 | In distribution | |
| 601-19T | In distribution | |
| 601-21T | In distribution | |
| 602-25-8S | In distribution | |
| 601-13 | In distribution | |
| 612-045-12 | In distribution | |
| 601-08 | In distribution | |
| 601-06C | In distribution | |
| 601-03T | In distribution | |
| 610-030-21 | In distribution | |
| 601-04 | In distribution | |
| 615-PS-12 | In distribution | |
| 601-05C | In distribution | |
| 601-21 | In distribution | |
| 601-10T | In distribution | |
| 610-045-21 | In distribution | |
| 620-B24 | In distribution | |
| 602-11-8S | In distribution | |
| 601-16C | In distribution | |
| 601-01C | In distribution | |
| 610-045-09 | In distribution | |
| 601-04C | In distribution | |
| 612-036-21 | In distribution | |
| 610-036-12 | In distribution | |
| 601-11C | In distribution | |
| 610-045-12 | In distribution | |
| 615-KS-12 | In distribution | |
| 601-19 | In distribution | |
| 602-19 | In distribution | |
| 601-15C | In distribution | |
| 602-215-3S | In distribution | |
| 601-07 | In distribution | |
| 601-05T | In distribution | |
| 620-B32 | In distribution | |
| 602-14 | In distribution | |
| 601-11 | In distribution | |
| 601-07C | In distribution | |
| 612-036-15 | In distribution | |
| 602-155-6S | In distribution | |
| 602-11 | In distribution | |
| 602-175-6S | In distribution | |
| 601-22 | In distribution | |
| 612-030-21 | In distribution | |
| 612-030-12 | In distribution | |
| 615-PL-12 | In distribution | |
| 601-65T | In distribution | |
| 601-20C | In distribution | |
| 602-20 | In distribution | |
| 615-PL-14 | In distribution | |
| 601-14 | In distribution | |
| 615-KS-10 | In distribution | |
| 610-030-12 | In distribution | |
| 602-195-3S | In distribution | |
| 601-01 | In distribution | |
| 612-036-12 | In distribution | |
| 601-20 | In distribution | |
| 620-B40 | In distribution | |
| 602-15 | In distribution | |
| 615-KL-14 | In distribution | |
| 602-01 | In distribution | |
| 601-22C | In distribution | |
| 610-030-15 | In distribution | |
| 601-14T | In distribution | |
| 601-13C | In distribution | |
| 612-030-15 | In distribution | |
| 612-045-15 | In distribution | |
| 601-15T | In distribution | |
| 601-66T | In distribution | |
| 601-20T | In distribution | |
| 601-21C | In distribution | |
| 601-45T | In distribution | |
| 601-03 | In distribution | |
| 610-030-07 | In distribution | |
| 602-21 | In distribution | |
| 602-21-8S | In distribution | |
| 610-036-07 | In distribution | |
| 601-02 | In distribution | |
| 615-KL-12 | In distribution | |
| 602-13 | 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
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.