Tru-Arch Align
TRU-ARCH ALIGN SE200 UM 017X025 NiTi DIMPLE BULK 10PK
43manufacturers in China registered for this device type
110catalogue 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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 0.012 to 0.02 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 227-3135 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3306 | Wire size 018 x 025 inches | 10 | In distribution |
| 227-3679 | Wire size 018 x 018 inches | 10 | In distribution |
| 227-3255 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3367 | Outer Diameter.016 in | 10 | In distribution |
| 227-3308 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3649 | Wire size 020 x 020 inches | 10 | In distribution |
| 227-3237 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3121 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3115 | Wire size 018 x 025 inches | 10 | In distribution |
| 227-3210 | Outer Diameter.016 in | 10 | In distribution |
| 227-3236 | Wire size 018 x 025 inches | 10 | In distribution |
| 227-3269 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3228 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3494 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3286 | Outer Diameter.012 in | 10 | In distribution |
| 227-3242 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3263 | Wire size 018 x 025 inches | 10 | In distribution |
| 227-3340 | Wire size 018 x 025 inches | 10 | In distribution |
| 227-3125 | Outer Diameter.014 in | 10 | In distribution |
| 227-3207 | Outer Diameter.012 in | 10 | In distribution |
| 227-3241 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3218 | Outer Diameter.016 in | 10 | In distribution |
| 227-3111 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3400 | Outer Diameter.018 in | 10 | In distribution |
| 227-3142 | Wire size 018 x 025 inches | 10 | In distribution |
| 227-3213 | Outer Diameter.018 in | 10 | In distribution |
| 227-3211 | Outer Diameter.016 in | 10 | In distribution |
| 227-3318 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3330 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3267 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3128 | Outer Diameter.018 in | 10 | In distribution |
| 227-3361 | Outer Diameter.014 in | 10 | In distribution |
| 227-3145 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3143 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3298 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3152 | Outer Diameter.014 in | 10 | In distribution |
| 227-3253 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3385 | Outer Diameter.018 in | 10 | In distribution |
| 227-3216 | Outer Diameter.014 in | 10 | In distribution |
| 227-3480 | Outer Diameter.02 in | 10 | In distribution |
| 227-3227 | Wire size 016 x 016 inches | 10 | In distribution |
| 227-3275 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3257 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3209 | Outer Diameter.014 in | 10 | In distribution |
| 227-3344 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3238 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3154 | Outer Diameter.016 in | 10 | In distribution |
| 227-3138 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3229 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3226 | Wire size 016 x 016 inches | 10 | In distribution |
| 227-3221 | Outer Diameter.018 in | 10 | In distribution |
| 227-3144 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3231 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3157 | Outer Diameter.02 in | 10 | In distribution |
| 227-3220 | Outer Diameter.018 in | 10 | In distribution |
| 227-3251 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3402 | Outer Diameter.016 in | 10 | In distribution |
| 227-3292 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3230 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3127 | Outer Diameter.016 in | 10 | In distribution |
| 227-3365 | Outer Diameter.014 in | 10 | In distribution |
| 227-3335 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3582 | Outer Diameter.018 in | 10 | In distribution |
| 227-3156 | Outer Diameter.018 in | 10 | In distribution |
| 227-3324 | Wire size 016 x 016 inches | 10 | In distribution |
| 227-3326 | Wire size 016 x 016 inches | 10 | In distribution |
| 227-3212 | Outer Diameter.018 in | 10 | In distribution |
| 227-3137 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3117 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3352 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3675 | Wire size 020 x 020 inches | 10 | In distribution |
| 227-3332 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3109 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3328 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3676 | Wire size 018 x 018 inches | 10 | In distribution |
| 227-3249 | Wire size 016 x 016 inches | 10 | In distribution |
| 227-3371 | Outer Diameter.018 in | 10 | In distribution |
| 227-3278 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3141 | Wire size 018 x 025 inches | 10 | In distribution |
| 227-3288 | Wire size 016 x 016 inches | 10 | In distribution |
| 227-3235 | Wire size 018 x 025 inches | 10 | In distribution |
| 227-3219 | Outer Diameter.016 in | 10 | In distribution |
| 227-3381 | Outer Diameter.016 in | 10 | In distribution |
| 227-3369 | Outer Diameter.016 in | 10 | In distribution |
| 227-3296 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3484 | Outer Diameter.02 in | 10 | In distribution |
| 227-3284 | Outer Diameter.012 in | 10 | In distribution |
| 227-3316 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3155 | Outer Diameter.018 in | 10 | In distribution |
| 227-3310 | Wire size 019 x 025 inches | 10 | In distribution |
| 227-3146 | Wire size 021 x 025 inches | 10 | In distribution |
| 227-3398 | Outer Diameter.016 in | 10 | In distribution |
| 227-3130 | Outer Diameter.02 in | 10 | In distribution |
| 227-3503 | Wire size 017 x 025 inches | 10 | In distribution |
| 227-3224 | Outer Diameter.012 in | 10 | In distribution |
| 227-3677 | Wire size 016 x 016 inches | 10 | In distribution |
| 227-3377 | Outer Diameter.014 in | 10 | In distribution |
| 227-3674 | Wire size 016 x 016 inches | 10 | In distribution |
| 227-3294 | Wire size 016 x022 inches | 10 | In distribution |
| 227-3217 | Outer Diameter.014 in | 10 | In distribution |
| 227-3225 | Outer Diameter.012 in | 10 | In distribution |
| 227-3678 | Wire size 020 x 020 inches | 10 | In distribution |
| 227-3393 | Outer Diameter.012 in | 10 | In distribution |
| 227-3151 | Outer Diameter.014 in | 10 | In distribution |
| 227-3290 | Wire size 016 x 016 inches | 10 | In distribution |
| 227-3153 | Outer Diameter.016 in | 10 | In distribution |
| 227-3304 | Wire size 018 x 025 inches | 10 | In distribution |
| 227-3208 | Outer Diameter.014 in | 10 | In distribution |
| 227-3158 | Outer Diameter.02 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.