3m™ Unitek™
3M™ Unitek™ Archwire Hook, .025 in Extraoral Hook, For .018x.025 in. Rectangular Wire, Split Crimpable, 538-610, 10/Pk
27manufacturers in China registered for this device type
58catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (13), Jiangsu (5), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| 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 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Guangzhou Cheer-U Material Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 15 |
Showing 12 of 27. All 27 manufacturers in China registered for Clamp, Wire, Orthodontic
Record
| Listed by | 3M Unitek, United States |
|---|---|
| FDA product code | ECN |
| Device type | Clamp, Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 532-242 | 10 | In distribution | |
| 561-200 | In distribution | ||
| 537-740 | 10 | In distribution | |
| 538-740 | 10 | In distribution | |
| 517-750 | 100 | In distribution | |
| 535-712 | 10 | In distribution | |
| 564-102 | In distribution | ||
| 536-610 | 10 | In distribution | |
| 517-740 | 100 | In distribution | |
| 538-610 | 10 | In distribution | |
| 536-750 | 10 | In distribution | |
| 532-142 | 10 | In distribution | |
| 533-710 | 10 | In distribution | |
| 560-200 | In distribution | ||
| 513-121 | 100 | In distribution | |
| 531-110 | 10 | In distribution | |
| 516-712 | 100 | In distribution | |
| 532-172 | 10 | In distribution | |
| 515-752 | 100 | In distribution | |
| 535-732 | 10 | In distribution | |
| 513-111 | 100 | In distribution | |
| 536-730 | 10 | In distribution | |
| 563-401 | In distribution | ||
| 532-122 | 10 | In distribution | |
| 532-322 | 10 | In distribution | |
| 560-400 | In distribution | ||
| 534-720 | 10 | In distribution | |
| 532-332 | 10 | In distribution | |
| 517-610 | 100 | In distribution | |
| 516-742 | 100 | In distribution | |
| 563-102 | In distribution | ||
| 563-202 | In distribution | ||
| 562-102 | In distribution | ||
| 563-101 | In distribution | ||
| 517-620 | 100 | In distribution | |
| 534-710 | 10 | In distribution | |
| 561-400 | In distribution | ||
| 536-620 | 10 | In distribution | |
| 534-740 | 10 | In distribution | |
| 533-740 | 10 | In distribution | |
| 518-740 | 100 | In distribution | |
| 518-610 | 100 | In distribution | |
| 563-201 | In distribution | ||
| 535-752 | 10 | In distribution | |
| 310-200 | 10 | In distribution | |
| 516-722 | 100 | In distribution | |
| 532-162 | 10 | In distribution | |
| 533-720 | 10 | In distribution | |
| 537-610 | 10 | In distribution | |
| 517-730 | 100 | In distribution | |
| 560-100 | In distribution | ||
| 562-101 | In distribution | ||
| 563-402 | In distribution | ||
| 536-740 | 10 | In distribution | |
| 078-046 | 10 | In distribution | |
| 515-712 | 100 | In distribution | |
| 530-110 | 10 | In distribution | |
| 560-300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lingual Sheaths | American Orthodontics | 36 |
| Crimpable Stop | American Orthodontics | 29 |
| Arch Hook | American Orthodontics | 26 |
| JMU | JMU Dental, Inc | 25 |
| Clamp, Wire, Orthodontic | Dentaurum GmbH & Co. KG | 24 |
| OSE | Orthodontic Supply & Equipment Co., Inc. | 22 |
| Buttons | American Orthodontics | 22 |
| Morelli | Dental Morelli Ltda. | 21 |
| Arch Lock | American Orthodontics | 19 |
| ORJ | Fortune Worldwide LLC | 18 |
| The Orthodontic Store | Young Innovations Inc. | 17 |
| DTC | Hangzhou DTC Medical Apparatus Co., Ltd. | 16 |
Showing 12 of 405. All products under Clamp, Wire, 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.