Straight Length Wire
Wire TMA Round 27 DIA X 14 IN PK 10
43manufacturers in China registered for this device type
32catalogue numbers in this listing
1510(k) clearance
1recall
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 | Ormco Corporation, United States |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
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 | Outer diameter 0.015 to 0.036 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 266-1318 | 40 | In distribution | |
| 266-1332 | Outer Diameter.032 in | 20 | In distribution |
| 266-1330 | 30 | In distribution | |
| 266-1316 | 40 | In distribution | |
| 264-0175 | Outer Diameter.017 in | 10 | In distribution |
| 266-0011 | Wire size 017 x 025 inches | 10 | In distribution |
| 266-0006 | Outer Diameter.027 in | 10 | In distribution |
| 254-2125 | Wire size 021 x 025 inches | 10 | In distribution |
| 264-1119 | Outer Diameter.019 in | 10 | In distribution |
| 266-0005 | Outer Diameter.036 in | 10 | In distribution |
| 266-0010 | Wire size 016 x022 inches | 10 | In distribution |
| 266-0004 | Outer Diameter.032 in | 10 | In distribution |
| 264-1115 | Outer Diameter.015 in | 10 | In distribution |
| 266-0012 | Wire size 0175 X 0175 inches | 10 | In distribution |
| 266-0002 | Outer Diameter.018 in | 10 | In distribution |
| 254-1722 | Wire size 017 x 022 inches | 10 | In distribution |
| 266-1328 | 30 | In distribution | |
| 266-0051 | Wire size 016 x022 inches | 10 | In distribution |
| 266-1320 | 40 | In distribution | |
| 266-1314 | 50 | In distribution | |
| 254-1825 | Wire size 018 x 025 inches | 10 | In distribution |
| 254-1822 | Wire size 018X022 inches | 10 | In distribution |
| 254-1622 | Wire size 016 x022 inches | 10 | In distribution |
| 266-0050 | Wire size 016 x 016 inches | 10 | In distribution |
| 254-1725 | Wire size 017 x 025 inches | 10 | In distribution |
| 266-0013 | Wire size 019 x 025 inches | 10 | In distribution |
| 264-0150 | Outer Diameter.015 in | 10 | In distribution |
| 254-1925 | Wire size 019 x 025 inches | 10 | In distribution |
| 252-1616 | Wire size 016 x 016 inches | 10 | In distribution |
| 264-1117 | Outer Diameter.017 in | 10 | In distribution |
| 266-1336 | Outer Diameter.036 in | 20 | In distribution |
| 266-1312 | 50 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112640 | 2011-11-16 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-03-15 | Not classified | Packaging | The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007. | 23 Packs | 2012-03-08 |
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.