Lingual Sheaths
Weld Lingual Sheath UR 036 Slotted R7M W/Dist Indent LG HK Dist
27manufacturers in China registered for this device type
36catalogue 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 | American Orthodontics, United States |
|---|---|
| FDA product code | ECN |
| Device type | Clamp, Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-06-15 |
| Record revised | 2024-05-30 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2021-11-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 852-032960 | In distribution | |
| 852-033070 | In distribution | |
| 852-143L | In distribution | |
| 852-111B | In distribution | |
| 852-146AR | In distribution | |
| 852-141 | In distribution | |
| 852-146AL | In distribution | |
| 852-032959 | In distribution | |
| 852-140 | In distribution | |
| 852-146R | In distribution | |
| 852-032961 | In distribution | |
| 852-130 | In distribution | |
| 852-033069 | In distribution | |
| 852-141BAL | In distribution | |
| 852-141BL | In distribution | |
| 852-123L | In distribution | |
| 852-142L | In distribution | |
| 852-032958 | In distribution | |
| 852-032954 | In distribution | |
| 852-123R | In distribution | |
| 852-141BAR | In distribution | |
| 852-131BL | In distribution | |
| 852-146L | In distribution | |
| 852-143R | In distribution | |
| 852-133 | In distribution | |
| 852-110 | In distribution | |
| 852-032957 | In distribution | |
| 852-032956 | In distribution | |
| 852-142R | In distribution | |
| 852-131 | In distribution | |
| 852-120 | In distribution | |
| 852-121 | In distribution | |
| 852-131BR | In distribution | |
| 852-141BR | In distribution | |
| 852-111 | In distribution | |
| 852-147 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Unitek™ | 3M Unitek | 58 |
| 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.