TMA – Archwire
TMA Rev.curve/Loops 016X022 38MM PK/5
43manufacturers in China registered for this device type
106catalogue 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 | 2022-12-06 |
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, expiry date, manufacturing date |
| Sizes | Outer diameter 0.016 to 0.021 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 215-0025 | Wire size 016 X022 inches | 5 | In distribution |
| 211-1412 | Wire size 016X022 inches | 10 | In distribution |
| 202-0020 | Wire size 017X025 inches | 10 | In distribution |
| 216-0004 | Wire size 017 X025 inches | 10 | In distribution |
| 210-4402 | Wire size 016X022 inches | 5 | In distribution |
| 216-0005 | Wire size 019 X025 inches | 10 | In distribution |
| 211-0415 | Wire size 0210X0250 inches | 10 | In distribution |
| 215-0022 | Wire size 016 X022 inches | 5 | In distribution |
| 211-5404 | Wire size 019X025 inches | 5 | In distribution |
| 202-0016 | Wire size 0175X0175 inches | 10 | In distribution |
| 215-0033 | Wire size 017 X025 inches | 5 | In distribution |
| 215-0026 | Wire size 016 X022 inches | 5 | In distribution |
| 210-1413 | Wire size 017 x 025 inches | 10 | In distribution |
| 211-0311 | Outer Diameter.016 in | 10 | In distribution |
| 202-0003 | Outer Diameter.016 in | 10 | In distribution |
| 211-1414 | Wire size 019X025 inches | 10 | In distribution |
| 206-0074 | Large Upper 42mm | 5 | In distribution |
| 215-0044 | Wire size 019 X025 inches | 5 | In distribution |
| 202-0025 | Outer Diameter.016 in | 10 | In distribution |
| 207-0073 | Lower Medium 42mm | 5 | In distribution |
| 202-0014 | Wire size 016X022 inches | 10 | In distribution |
| 211-1413 | Wire size 017X025 inches | 10 | In distribution |
| 211-4402 | Wire size 016X022 inches | 5 | In distribution |
| 210-5402 | Wire size 016X022 inches | 5 | In distribution |
| 202-0005 | Outer Diameter.016 in | 10 | In distribution |
| 215-0031 | Wire size 017 X025 inches | 5 | In distribution |
| 215-0046 | Wire size 019 X025 inches | 5 | In distribution |
| 215-0042 | Wire size 019 X025 inches | 5 | In distribution |
| 210-1414 | Wire size 019 x 025 inches | 10 | In distribution |
| 211-0312 | Outer Diameter.018 in | 10 | In distribution |
| 210-4414 | Wire size 019X025 inches | 5 | In distribution |
| 215-0032 | Wire size 017 X025 inches | 5 | In distribution |
| 211-1403 | Wire size 017X025 inches | 10 | In distribution |
| 210-5413 | Wire size 017X025 inches | 5 | In distribution |
| 211-0411 | Wire size 0175X0175 inches | 10 | In distribution |
| 211-0302 | Outer Diameter.018 in | 10 | In distribution |
| 211-0401 | Wire size 0175X0175 inches | 10 | In distribution |
| 210-0301 | Outer Diameter.016 in | 10 | In distribution |
| 202-0013 | Wire size 021X025 inches | 10 | In distribution |
| 211-5403 | Wire size 017X025 inches | 5 | In distribution |
| 211-1404 | Wire size 019X025 inches | 10 | In distribution |
| 211-4414 | Wire size 019X025 inches | 5 | In distribution |
| 202-1007 | Wire size 017X025 inches | 10 | In distribution |
| 206-0073 | Medium Upper 40mm | 5 | In distribution |
| 210-0302 | Outer Diameter.018 in | 10 | In distribution |
| 211-5413 | Wire size 017X025 inches | 5 | In distribution |
| 215-0023 | Wire size 016 X022 inches | 5 | In distribution |
| 207-0071 | Lower Small 38mm | 5 | In distribution |
| 211-4404 | Wire size 019X025 inches | 5 | In distribution |
| 210-0311 | Outer Diameter.016 in | 10 | In distribution |
| 210-0312 | Outer Diameter.018 in | 10 | In distribution |
| 210-5414 | Wire size 019X025 inches | 5 | In distribution |
| 210-0411 | Outer Diameter.018 in | 10 | In distribution |
| 211-1402 | Wire size 016X022 inches | 10 | In distribution |
| 206-0070 | Small Upper 34mm | 5 | In distribution |
| 210-0415 | Outer Diameter.021 in | 10 | In distribution |
| 211-4413 | Wire size 017X025 inches | 5 | In distribution |
| 210-4403 | Wire size 017X025 inches | 5 | In distribution |
| 207-0072 | Lower Medium 40mm | 5 | In distribution |
| 216-0003 | Wire size 016 X022 inches | 10 | In distribution |
| 215-0034 | Wire size 017 X025 inches | 5 | In distribution |
| 210-4412 | Wire size 016X022 inches | 5 | In distribution |
| 211-0405 | Wire size 0210X0250 inches | 10 | In distribution |
| 211-4403 | Wire size 017X025 inches | 5 | In distribution |
| 206-0072 | Medium Upper 38mm | 5 | In distribution |
| 207-0074 | Lower Large 44mm | 5 | In distribution |
| 215-0036 | Wire size 017 X025 inches | 5 | In distribution |
| 206-0076 | Wire size 017X025 inches | In distribution | |
| 211-0301 | Outer Diameter.016 in | 10 | In distribution |
| 211-5402 | Wire size 016X022 inches | 5 | In distribution |
| 202-0011 | Wire size 016X022 inches | 10 | In distribution |
| 206-0071 | Small Upper 36mm | 5 | In distribution |
| 215-0003 | Wire size 016 X022 inches | 10 | In distribution |
| 202-1009 | Wire size 017X025 inches | 10 | In distribution |
| 215-0005 | Wire size 019 X025 inches | 10 | In distribution |
| 210-1402 | Wire size 016 x022 inches | 10 | In distribution |
| 210-0401 | Outer Diameter.018 in | 10 | In distribution |
| 202-1010 | Wire size 019X025 inches | 10 | In distribution |
| 210-0405 | Outer Diameter.021 in | 10 | In distribution |
| 215-0024 | Wire size 016 X022 inches | 5 | In distribution |
| 207-0075 | Lower Large 46mm | 5 | In distribution |
| 210-1412 | Wire size 016 x022 inches | 10 | In distribution |
| 202-0006 | Outer Diameter.018 in | 10 | In distribution |
| 211-4412 | Wire size 016X022 inches | 5 | In distribution |
| 210-5403 | Wire size 017X025 inches | 5 | In distribution |
| 215-0043 | Wire size 019 X025 inches | 5 | In distribution |
| 210-4413 | Wire size 017X025 inches | 5 | In distribution |
| 202-0012 | Wire size 0175X0175 inches | 10 | In distribution |
| 202-0017 | Wire size 021X025 inches | 10 | In distribution |
| 202-0018 | Wire size 0175X0175 inches | 10 | In distribution |
| 215-0021 | Wire size 016 X022 inches | 5 | In distribution |
| 210-1404 | Wire size 019 x 025 inches | 10 | In distribution |
| 210-5412 | Wire size 016X022 inches | 5 | In distribution |
| 215-0045 | Wire size 019 X025 inches | 5 | In distribution |
| 210-1403 | Wire size 017 x 025 inches | 10 | In distribution |
| 215-0041 | Wire size 019 X025 inches | 5 | In distribution |
| 202-0004 | Outer Diameter.018 in | 10 | In distribution |
| 210-5404 | Wire size 019X025 inches | 5 | In distribution |
| 215-0035 | Wire size 017 X025 inches | 5 | In distribution |
| 206-0075 | Large Upper 44mm | 5 | In distribution |
| 202-1008 | Wire size 019X025 inches | 10 | In distribution |
| 215-0004 | Wire size 017 X025 inches | 10 | In distribution |
| 210-4404 | Wire size 019X025 inches | 5 | In distribution |
| 207-0076 | Wire size 016X022 inches | In distribution | |
| 211-5414 | Wire size 019X025 inches | 5 | In distribution |
| 207-0070 | Lower Small 36mm | 5 | 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.