Tru-Arch Copper Ni-Ti
TRU-Arch Cuniti NON-DIMP35D 017X017 LS W/Stops PK10
43manufacturers in China registered for this device type
131catalogue 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 0.014 to 0.018 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 210-9211 | Wire size 017X017 inches | 10 | In distribution |
| 205-6433 | Outer Diameter.018 in | 10 | In distribution |
| 227-1371 | Outer Diameter.018 in | 10 | In distribution |
| 210-9215 | Wire size 019X025 inches | 10 | In distribution |
| 227-1303 | Wire size 017 x 017 inches | 10 | In distribution |
| 211-9102 | Wire size 016X025 inches | 10 | In distribution |
| 211-9221 | Wire size 014X025 inches | 10 | In distribution |
| 210-9223 | Wire size 016X022 inches | 10 | In distribution |
| 227-1360 | Outer Diameter.014 in | 10 | In distribution |
| 205-6222 | Outer Diameter.016 in | 10 | In distribution |
| 205-6112 | Outer Diameter.016 in | 10 | In distribution |
| 211-9103 | Wire size 016X022 inches | 10 | In distribution |
| 210-9235 | Wire size 019X025 inches | 10 | In distribution |
| 211-9131 | Wire size 017X017 inches | 10 | In distribution |
| 210-9233 | Wire size 016X022 inches | 10 | In distribution |
| 211-9215 | Wire size 019X025 inches | 10 | In distribution |
| 210-9115 | Wire size 019X025 inches | 10 | In distribution |
| 210-9112 | Wire size 020X020 inches | 10 | In distribution |
| 205-6321 | Outer Diameter.014 in | 10 | In distribution |
| 205-6312 | Outer Diameter.016 in | 10 | In distribution |
| 211-9202 | Wire size 016X025 inches | 10 | In distribution |
| 210-9123 | Wire size 016X022 inches | 10 | In distribution |
| 205-6223 | Outer Diameter.018 in | 10 | In distribution |
| 205-6201 | Outer Diameter.014 in | 10 | In distribution |
| 211-9135 | Wire size 019X025 inches | 10 | In distribution |
| 210-9234 | Wire size 017X025 inches | 10 | In distribution |
| 205-6413 | Outer Diameter.018 in | 10 | In distribution |
| 211-9205 | Wire size 019X025 inches | 10 | In distribution |
| 211-9204 | Wire size 017X025 inches | 10 | In distribution |
| 227-1304 | Wire size 017 x 017 inches | 10 | In distribution |
| 205-6101 | Outer Diameter.014 in | 10 | In distribution |
| 227-1361 | Outer Diameter.014 in | 10 | In distribution |
| 210-9205 | Wire size 019X025 inches | 10 | In distribution |
| 227-1323 | Wire size 020X020 inches | 10 | In distribution |
| 211-9213 | Wire size 016X022 inches | 10 | In distribution |
| 205-6412 | Outer Diameter.016 in | 10 | In distribution |
| 227-1331 | Wire size 019X025 inches | 10 | In distribution |
| 211-9222 | Wire size 016X025 inches | 10 | In distribution |
| 211-9121 | Wire size 014X025 inches | 10 | In distribution |
| 205-6301 | Outer Diameter.014 in | 10 | In distribution |
| 210-9133 | Wire size 016X022 inches | 10 | In distribution |
| 210-9114 | Wire size 017X025 inches | 10 | In distribution |
| 211-9233 | Wire size 016X022 inches | 10 | In distribution |
| 227-1333 | Wire size 019X025 inches | 10 | In distribution |
| 205-6102 | Outer Diameter.016 in | 10 | In distribution |
| 205-6123 | Outer Diameter.018 in | 10 | In distribution |
| 205-6302 | Outer Diameter.016 in | 10 | In distribution |
| 205-6132 | Outer Diameter.016 in | 10 | In distribution |
| 205-6121 | Outer Diameter.014 in | 10 | In distribution |
| 211-9111 | Wire size 017X017 inches | 10 | In distribution |
| 211-9201 | Wire size 014X025 inches | 10 | In distribution |
| 205-6103 | Outer Diameter.018 in | 10 | In distribution |
| 210-9134 | Wire size 017X025 inches | 10 | In distribution |
| 211-9234 | Wire size 017X025 inches | 10 | In distribution |
| 210-9222 | Wire size 016X025 inches | 10 | In distribution |
| 211-9123 | Wire size 016X022 inches | 10 | In distribution |
| 210-9135 | Wire size 019X025 inches | 10 | In distribution |
| 205-6212 | Outer Diameter.016 in | 10 | In distribution |
| 210-9213 | Wire size 016X022 inches | 10 | In distribution |
| 210-9204 | Wire size 017X025 inches | 10 | In distribution |
| 205-6403 | Outer Diameter.018 in | 10 | In distribution |
| 210-9132 | Wire size 020X020 inches | 10 | In distribution |
| 211-9231 | Wire size 017X017 inches | 10 | In distribution |
| 227-1322 | Wire size 020X020 inches | 10 | In distribution |
| 227-1302 | Wire size 017 x 017 inches | 10 | In distribution |
| 205-6332 | Outer Diameter.016 in | 10 | In distribution |
| 205-6303 | Outer Diameter.018 in | 10 | In distribution |
| 205-6402 | Outer Diameter.016 in | 10 | In distribution |
| 205-6333 | Outer Diameter.018 in | 10 | In distribution |
| 205-6323 | Outer Diameter.018 in | 10 | In distribution |
| 210-9105 | Wire size 019X025 inches | 10 | In distribution |
| 205-6113 | Outer Diameter.018 in | 10 | In distribution |
| 227-1334 | Wire size 019X025 inches | 10 | In distribution |
| 205-6422 | Outer Diameter.016 in | 10 | In distribution |
| 211-9203 | Wire size 016X022 inches | 10 | In distribution |
| 210-9201 | Wire size 014X025 inches | 10 | In distribution |
| 211-9104 | Wire size 017X025 inches | 10 | In distribution |
| 227-1301 | Wire size 017 x 017 inches | 10 | In distribution |
| 227-1312 | Wire size 017X025 inches | 10 | In distribution |
| 210-9221 | Wire size 014X025 inches | 10 | In distribution |
| 210-9113 | Wire size 016X022 inches | 10 | In distribution |
| 205-6122 | Outer Diameter.016 in | 10 | In distribution |
| 205-6313 | Outer Diameter.018 in | 10 | In distribution |
| 205-6203 | Outer Diameter.018 in | 10 | In distribution |
| 205-6423 | Outer Diameter.018 in | 10 | In distribution |
| 210-9212 | Wire size 020X020 inches | 10 | In distribution |
| 211-9211 | Wire size 017X017 inches | 10 | In distribution |
| 211-9115 | Wire size 019X025 inches | 10 | In distribution |
| 211-9232 | Wire size 020X020 inches | 10 | In distribution |
| 211-9101 | Wire size 014X025 inches | 10 | In distribution |
| 211-9114 | Wire size 017X025 inches | 10 | In distribution |
| 210-9131 | Wire size 017X017 inches | 10 | In distribution |
| 227-1313 | Wire size 017X025 inches | 10 | In distribution |
| 227-1314 | Wire size 017X025 inches | 10 | In distribution |
| 227-1370 | Outer Diameter.018 in | 10 | In distribution |
| 211-9105 | Wire size 019X025 inches | 10 | In distribution |
| 211-9112 | Wire size 020X020 inches | 10 | In distribution |
| 211-9223 | Wire size 016X022 inches | 10 | In distribution |
| 211-9212 | Wire size 020X020 inches | 10 | In distribution |
| 210-9111 | Wire size 017X017 inches | 10 | In distribution |
| 227-1324 | Wire size 020X020 inches | 10 | In distribution |
| 205-6401 | Outer Diameter.014 in | 10 | In distribution |
| 205-6421 | Outer Diameter.014 in | 10 | In distribution |
| 205-6232 | Outer Diameter.016 in | 10 | In distribution |
| 205-6233 | Outer Diameter.018 in | 10 | In distribution |
| 205-6213 | Outer Diameter.018 in | 10 | In distribution |
| 210-9121 | Wire size 014X025 inches | 10 | In distribution |
| 210-9102 | Wire size 016X025 inches | 10 | In distribution |
| 211-9133 | Wire size 016X022 inches | 10 | In distribution |
| 210-9103 | Wire size 016X022 inches | 10 | In distribution |
| 211-9134 | Wire size 017X025 inches | 10 | In distribution |
| 210-9202 | Wire size 016X025 inches | 10 | In distribution |
| 205-6202 | Outer Diameter.016 in | 10 | In distribution |
| 205-6432 | Outer Diameter.016 in | 10 | In distribution |
| 211-9235 | Wire size 019X025 inches | 10 | In distribution |
| 211-9122 | Wire size 016X025 inches | 10 | In distribution |
| 205-6322 | Outer Diameter.016 in | 10 | In distribution |
| 210-9101 | Wire size 014X025 inches | 10 | In distribution |
| 210-9104 | Wire size 017X025 inches | 10 | In distribution |
| 205-6133 | Outer Diameter.018 in | 10 | In distribution |
| 211-9113 | Wire size 016X022 inches | 10 | In distribution |
| 210-9203 | Wire size 016X022 inches | 10 | In distribution |
| 210-9232 | Wire size 020X020 inches | 10 | In distribution |
| 227-1332 | Wire size 019X025 inches | 10 | In distribution |
| 210-9214 | Wire size 017X025 inches | 10 | In distribution |
| 211-9214 | Wire size 017X025 inches | 10 | In distribution |
| 227-1311 | Wire size 017X025 inches | 10 | In distribution |
| 227-1321 | Wire size 020X020 inches | 10 | In distribution |
| 210-9231 | Wire size 017X017 inches | 10 | In distribution |
| 211-9132 | Wire size 020X020 inches | 10 | In distribution |
| 205-6221 | Outer Diameter.014 in | 10 | 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.