Therma-Ti
Wire Therma TI Upper 016X022 W/Dimple Long Modified IND 10/PK
43manufacturers in China registered for this device type
228catalogue 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 | American Orthodontics, United States |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-11-24 |
| Record revised | 2020-06-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 0 to 60 % RH; Storage environment temperature up to 38 °C |
| Distribution end date | 2020-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 858-513IDSPW | Withdrawn | |
| 858-551D | Withdrawn | |
| 858-555W | Withdrawn | |
| 858-516I | Withdrawn | |
| 858-543IW | Withdrawn | |
| 858-555ID | Withdrawn | |
| 858-513DSPW | Withdrawn | |
| 858-508D | Withdrawn | |
| 858-554D | Withdrawn | |
| 858-516IDW | Withdrawn | |
| 858-550IW | Withdrawn | |
| 858-516DW | Withdrawn | |
| 858-513IDSP | Withdrawn | |
| 858-508IW | Withdrawn | |
| 858-504DW | Withdrawn | |
| 858-540DSPW | Withdrawn | |
| 858-558W | Withdrawn | |
| 858-553 | Withdrawn | |
| 858-547DSPW | Withdrawn | |
| 858-544ID | Withdrawn | |
| 858-508I | Withdrawn | |
| 858-547DSP | Withdrawn | |
| 858-537I | Withdrawn | |
| 858-545D | Withdrawn | |
| 858-516IW | Withdrawn | |
| 858-558DSP | Withdrawn | |
| 858-551I | Withdrawn | |
| 858-539W | Withdrawn | |
| 858-506 | Withdrawn | |
| 858-551ID | Withdrawn | |
| 858-554I | Withdrawn | |
| 858-506ID | Withdrawn | |
| 858-548IW | Withdrawn | |
| 858-542IDW | Withdrawn | |
| 858-557 | Withdrawn | |
| 858-553DSPW | Withdrawn | |
| 858-550IDSP | Withdrawn | |
| 858-541DSP | Withdrawn | |
| 858-555 | Withdrawn | |
| 858-506D | Withdrawn | |
| 858-542I | Withdrawn | |
| 858-554W | Withdrawn | |
| 858-518DW | Withdrawn | |
| 858-508W | Withdrawn | |
| 858-514DW | Withdrawn | |
| 858-558IW | Withdrawn | |
| 858-548DSPW | Withdrawn | |
| 858-558I | Withdrawn | |
| 858-540IDSPW | Withdrawn | |
| 858-557IDSPW | Withdrawn | |
| 858-552W | Withdrawn | |
| 858-553I | Withdrawn | |
| 858-504IW | Withdrawn | |
| 858-503DSP | Withdrawn | |
| 858-553DSP | Withdrawn | |
| 858-548I | Withdrawn | |
| 858-549IDSP | Withdrawn | |
| 858-540 | Withdrawn | |
| 858-544D | Withdrawn | |
| 858-553W | Withdrawn | |
| 858-513W | Withdrawn | |
| 858-550IDSPW | Withdrawn | |
| 858-541M | Withdrawn | |
| 858-516 | Withdrawn | |
| 858-506IW | Withdrawn | |
| 858-555IW | Withdrawn | |
| 858-543DSP | Withdrawn | |
| 858-557I | Withdrawn | |
| 858-550 | Withdrawn | |
| 858-541IDSPW | Withdrawn | |
| 858-556 | Withdrawn | |
| 858-513IW | Withdrawn | |
| 858-543IDSPW | Withdrawn | |
| 858-542IW | Withdrawn | |
| 858-548 | Withdrawn | |
| 858-554IW | Withdrawn | |
| 858-553IDSP | Withdrawn | |
| 858-541MW | Withdrawn | |
| 858-552ID | Withdrawn | |
| 858-549DSP | Withdrawn | |
| 858-549DSPW | Withdrawn | |
| 858-503W | Withdrawn | |
| 858-539DSP | Withdrawn | |
| 858-539I | Withdrawn | |
| 858-546W | Withdrawn | |
| 858-546 | Withdrawn | |
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| 858-541 | Withdrawn | |
| 858-545W | Withdrawn | |
| 858-552D | Withdrawn | |
| 858-541DSPW | Withdrawn | |
| 858-553IDSPW | Withdrawn | |
| 858-545IW | Withdrawn | |
| 858-506W | Withdrawn | |
| 858-541I | Withdrawn | |
| 858-557IW | Withdrawn | |
| 858-503IW | Withdrawn | |
| 858-551IDW | Withdrawn | |
| 858-555D | Withdrawn | |
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| 858-544IDW | Withdrawn | |
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| 858-544IW | Withdrawn | |
| 858-504W | Withdrawn | |
| 858-543I | Withdrawn | |
| 858-547IW | Withdrawn | |
| 858-539IW | Withdrawn | |
| 858-518D | Withdrawn | |
| 858-508IDW | Withdrawn | |
| 858-518ID | Withdrawn | |
| 858-543DSPW | Withdrawn | |
| 858-504I | Withdrawn | |
| 858-518IW | Withdrawn | |
| 858-546DSP | Withdrawn | |
| 858-514W | Withdrawn | |
| 858-513DSP | Withdrawn | |
| 858-556DSPW | Withdrawn | |
| 858-549W | Withdrawn | |
| 858-503DSPW | Withdrawn | |
| 858-556IW | Withdrawn | |
| 858-547IDSPW | Withdrawn | |
| 858-553IW | Withdrawn | |
| 858-506MW | Withdrawn | |
| 858-503 | Withdrawn | |
| 858-552 | Withdrawn | |
| 858-551M | Withdrawn | |
| 858-544 | Withdrawn | |
| 858-514IW | Withdrawn | |
| 858-504IDW | Withdrawn | |
| 858-543 | Withdrawn | |
| 858-541IDSP | Withdrawn | |
| 858-550W | Withdrawn | |
| 858-556IDSP | Withdrawn | |
| 858-504 | Withdrawn | |
| 858-547 | Withdrawn | |
| 858-539DSPW | Withdrawn | |
| 858-540IW | Withdrawn | |
| 858-508DW | Withdrawn | |
| 858-555I | Withdrawn | |
| 858-551IW | Withdrawn | |
| 858-551MW | Withdrawn | |
| 858-551DW | Withdrawn | |
| 858-546IW | Withdrawn | |
| 858-540DSP | Withdrawn | |
| 858-556W | Withdrawn | |
| 858-544W | Withdrawn | |
| 858-518W | Withdrawn | |
| 858-551W | Withdrawn | |
| 858-550DSPW | Withdrawn | |
| 858-545I | Withdrawn | |
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| 858-514IDW | Withdrawn | |
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| 858-548W | Withdrawn | |
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| 858-556IDSPW | Withdrawn | |
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| 858-551 | Withdrawn | |
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| 858-546IDSPW | Withdrawn | |
| 858-528I | Withdrawn | |
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| 858-541W | Withdrawn | |
| 858-549IDSPW | Withdrawn | |
| 858-539 | Withdrawn | |
| 858-514D | Withdrawn | |
| 858-557DSP | Withdrawn | |
| 858-542D | Withdrawn | |
| 858-543IDSP | Withdrawn | |
| 858-550DSP | Withdrawn | |
| 858-556DSP | Withdrawn | |
| 858-558DSPW | Withdrawn | |
| 858-516W | Withdrawn | |
| 858-547I | Withdrawn | |
| 858-544DW | Withdrawn | |
| 858-554IDW | Withdrawn | |
| 858-552IDW | Withdrawn | |
| 858-540I | Withdrawn | |
| 858-546IDSP | Withdrawn | |
| 858-542ID | Withdrawn | |
| 858-516D | Withdrawn | |
| 858-518 | Withdrawn | |
| 858-504D | Withdrawn | |
| 858-546I | Withdrawn | |
| 858-508ID | Withdrawn | |
| 858-552IW | Withdrawn | |
| 858-547IDSP | Withdrawn | |
| 858-555DW | Withdrawn | |
| 858-546DSPW | Withdrawn | |
| 858-539IDSP | Withdrawn | |
| 858-549 | Withdrawn | |
| 858-540IDSP | Withdrawn | |
| 858-545DW | Withdrawn | |
| 858-543W | Withdrawn | |
| 858-557DSPW | Withdrawn | |
| 858-527I | Withdrawn | |
| 858-516MW | Withdrawn | |
| 858-514I | Withdrawn | |
| 858-550I | Withdrawn | |
| 858-548DSP | Withdrawn | |
| 858-504ID | Withdrawn | |
| 858-513I | Withdrawn | |
| 858-513 | Withdrawn | |
| 858-541IW | Withdrawn | |
| 858-549I | Withdrawn | |
| 858-542W | Withdrawn | |
| 858-547W | Withdrawn | |
| 858-503I | Withdrawn | |
| 858-506IDW | Withdrawn | |
| 858-555IDW | Withdrawn | |
| 858-506DW | Withdrawn | |
| 858-518IDW | Withdrawn | |
| 858-514ID | Withdrawn |
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.