3m™ Unitek™
Unitek(TM) Miniature Twin Bracket Roth U/L 5X5 6DistalRotation-Cuspid 3,4,5Hk .018 Kt
52manufacturers in China registered for this device type
152catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (19), Guangdong (11), Jiangsu (9). 6 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 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Chengdu Sani Medical Equipment Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 12 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
Showing 12 of 52. All 52 manufacturers in China registered for Bracket, Metal, Orthodontic
Record
| Listed by | 3m do Brasil Ltda. |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2024-10-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-10-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 017-323 | 5 | In distribution | |
| 001-379 | 10 | In distribution | |
| 017-490 | 5 | In distribution | |
| 001-633 | 10 | In distribution | |
| 017-304B | 50 | In distribution | |
| 017-216 | 5 | In distribution | |
| 017-304 | 5 | In distribution | |
| 017-302B | 50 | In distribution | |
| 017-316B | 50 | In distribution | |
| 017-312 | 5 | In distribution | |
| 017-389 | 5 | In distribution | |
| 017-319B | 50 | In distribution | |
| 017-114 | 2 | In distribution | |
| 017-102 | 2 | In distribution | |
| 017-212 | 5 | In distribution | |
| 017-334 | 5 | In distribution | |
| 017-240 | 5 | In distribution | |
| 017-212B | 50 | In distribution | |
| 017-232 | 5 | In distribution | |
| 017-231 | 5 | In distribution | |
| 017-333 | 5 | In distribution | |
| 017-207 | 5 | In distribution | |
| 017-239 | 5 | In distribution | |
| 017-308B | 50 | In distribution | |
| 017-249B | 50 | In distribution | |
| 017-1021 | 2 | In distribution | |
| 017-341 | 5 | In distribution | |
| 017-1061 | 2 | In distribution | |
| 017-204B | 50 | In distribution | |
| 017-316 | 5 | In distribution | |
| 001-376 | 10 | In distribution | |
| 001-361 | 10 | In distribution | |
| 017-201 | 5 | In distribution | |
| 017-338 | 5 | In distribution | |
| 017-342 | 5 | In distribution | |
| 017-222 | 5 | In distribution | |
| 017-332 | 5 | In distribution | |
| 017-309 | 5 | In distribution | |
| 017-491 | 5 | In distribution | |
| 017-133 | In distribution | ||
| 017-344 | 5 | In distribution | |
| 001-334 | 10 | In distribution | |
| 017-307B | 50 | In distribution | |
| 017-223 | 5 | In distribution | |
| 017-209B | 50 | In distribution | |
| 017-349 | 5 | In distribution | |
| 001-377 | 10 | In distribution | |
| 017-237 | 5 | In distribution | |
| 017-244 | 5 | In distribution | |
| 017-303 | 5 | In distribution | |
| 017-208 | 5 | In distribution | |
| 001-617 | 10 | In distribution | |
| 017-215 | 5 | In distribution | |
| 001-523 | 10 | In distribution | |
| 017-112 | 2 | In distribution | |
| 017-1121 | 2 | In distribution | |
| 017-321 | 5 | In distribution | |
| 001-375 | 10 | In distribution | |
| 017-315 | 5 | In distribution | |
| 017-478 | 5 | In distribution | |
| 017-489 | 5 | In distribution | |
| 017-350 | 5 | In distribution | |
| 017-221 | 5 | In distribution | |
| 017-317 | 5 | In distribution | |
| 001-309 | 10 | In distribution | |
| 017-203B | 50 | In distribution | |
| 001-310 | 10 | In distribution | |
| 017-317B | 50 | In distribution | |
| 017-1041 | 2 | In distribution | |
| 017-339 | 5 | In distribution | |
| 017-340 | 5 | In distribution | |
| 017-337 | 5 | In distribution | |
| 017-305 | 5 | In distribution | |
| 017-234 | 5 | In distribution | |
| 017-217B | 50 | In distribution | |
| 017-204 | 5 | In distribution | |
| 017-492 | 5 | In distribution | |
| 001-374 | 10 | In distribution | |
| 017-238 | 5 | In distribution | |
| 017-218 | 5 | In distribution | |
| 017-343 | 5 | In distribution | |
| 017-134 | In distribution | ||
| 017-202B | 50 | In distribution | |
| 017-104 | 2 | In distribution | |
| 017-224 | 5 | In distribution | |
| 017-477 | 5 | In distribution | |
| 017-243 | 5 | In distribution | |
| 017-207B | 50 | In distribution | |
| 017-352 | 5 | In distribution | |
| 017-306 | 5 | In distribution | |
| 017-390 | 5 | In distribution | |
| 017-351 | 5 | In distribution | |
| 001-337 | 10 | In distribution | |
| 017-303B | 50 | In distribution | |
| 017-311 | 5 | In distribution | |
| 017-201B | 50 | In distribution | |
| 001-764 | 10 | In distribution | |
| 017-208B | 50 | In distribution | |
| 017-121 | In distribution | ||
| 017-120 | 2 | In distribution | |
| 001-623 | 10 | In distribution | |
| 017-242 | 5 | In distribution | |
| 017-320B | 50 | In distribution | |
| 017-318B | 50 | In distribution | |
| 017-252 | 5 | In distribution | |
| 017-213B | 50 | In distribution | |
| 001-533 | 10 | In distribution | |
| 017-240B | 50 | In distribution | |
| 017-307 | 5 | In distribution | |
| 001-534 | 10 | In distribution | |
| 017-331 | 5 | In distribution | |
| 017-220B | 50 | In distribution | |
| 017-213 | 5 | In distribution | |
| 017-249 | 5 | In distribution | |
| 017-301 | 5 | In distribution | |
| 017-202 | 5 | In distribution | |
| 017-205 | 5 | In distribution | |
| 017-319 | 5 | In distribution | |
| 017-320 | 5 | In distribution | |
| 017-309B | 50 | In distribution | |
| 017-313B | 50 | In distribution | |
| 017-313 | 5 | In distribution | |
| 017-220 | 5 | In distribution | |
| 017-211B | 50 | In distribution | |
| 017-480 | 5 | In distribution | |
| 017-241 | 5 | In distribution | |
| 017-209 | 5 | In distribution | |
| 017-217 | 5 | In distribution | |
| 017-218B | 50 | In distribution | |
| 017-203 | 5 | In distribution | |
| 017-391 | 5 | In distribution | |
| 001-329 | 10 | In distribution | |
| 017-206 | 5 | In distribution | |
| 017-219 | 5 | In distribution | |
| 017-233 | 5 | In distribution | |
| 017-219B | 50 | In distribution | |
| 017-251 | 5 | In distribution | |
| 017-322 | 5 | In distribution | |
| 017-302 | 5 | In distribution | |
| 001-333 | 10 | In distribution | |
| 017-479 | 5 | In distribution | |
| 001-327 | 10 | In distribution | |
| 017-308 | 5 | In distribution | |
| 017-301B | 50 | In distribution | |
| 017-250 | 5 | In distribution | |
| 017-318 | 5 | In distribution | |
| 017-211 | 5 | In distribution | |
| 017-392 | 5 | In distribution | |
| 001-380 | 10 | In distribution | |
| 017-324 | 5 | In distribution | |
| 017-379 | 5 | Withdrawn | |
| 017-380 | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leone SPA | Leone SPA | 2,306 |
| BioQuick® | Forestadent Bernhard Förster GmbH | 1,842 |
| Mini Master Series | American Orthodontics | 1,505 |
| Mini-Mono® | Forestadent Bernhard Förster GmbH | 1,225 |
| LP Low Profile | American Orthodontics | 1,204 |
| Mini Sprint® | Forestadent Bernhard Förster GmbH | 1,193 |
| Empower Bracket | American Orthodontics | 1,175 |
| Legend | GC Orthodontics America Inc. | 1,098 |
| Master Series | American Orthodontics | 1,084 |
| Experience® | GC Orthodontics America Inc. | 770 |
| The Orthodontic Store | Young Innovations Inc. | 658 |
| equilibrium® | Dentaurum GmbH & Co. KG | 646 |
Showing 12 of 876. All products under Bracket, Metal, 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.