3m™ Unitek™ Lingual Sheaths
3M™ Unitek™ Lingual Sheaths, 080-254P, UR/LL, Horizontal, Slotted, .036, Hk, Latch, 5/Pk
16manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Shanghai (3), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Changsha Easyinsmile Intelligence Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
| Guangzhou Cheer-U Material Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 15 |
| Innovative Material & Devices, Inc. | Wuxi | Jiangsu | Contract manufacturer | 13 |
| Astar Orthodontics Inc. | Shanghai | Shanghai | Manufacturer | 12 |
| Wuhu Guli Ortho Co., Ltd. | Wuhu | Anhui | Contract manufacturer | 12 |
Showing 12 of 16. All 16 manufacturers in China registered for Band, Material, Orthodontic
Record
| Listed by | 3M Unitek, United States |
|---|---|
| FDA product code | DYO |
| Device type | Band, Material, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2026-04-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 080-254P | 5 | In distribution | |
| 080-270P | 5 | In distribution | |
| 080-100P | 5 | In distribution | |
| 080-245P | 5 | In distribution | |
| 080-230P | 5 | In distribution | |
| 080-110P | 5 | In distribution | |
| 080-210P | 5 | In distribution | |
| 080-252P | 5 | In distribution | |
| 080–216 | In distribution | ||
| 080-251P | 5 | In distribution | |
| 080-231P | 5 | In distribution | |
| 080-131P | 5 | In distribution | |
| 080-211P | 5 | In distribution | |
| 080-246P | 5 | In distribution | |
| 080-253P | 5 | In distribution | |
| 080-140P | 5 | In distribution | |
| 080-243P | 5 | In distribution | |
| 080-242P | 5 | In distribution | |
| 080-220P | 5 | In distribution | |
| 080-240P | 5 | In distribution | |
| 080-120P | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sure-Snap | GC Orthodontics America Inc. | 331 |
| Morelli | Dental Morelli Ltda. | 291 |
| A-FIT® | GC Orthodontics America Inc. | 264 |
| Bands & Attachments | World Class Technology Corporation | 133 |
| Legacy | GC Orthodontics America Inc. | 128 |
| Dental Sheet | Sichuan Yaqi Medical Technology Co., Ltd. | 96 |
| Ortho-Tain, Inc | Ortho-Tain, Inc. | 76 |
| Orthometric Bands | Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda | 62 |
| KGuard Pro | Ortho-Tain, Inc. | 10 |
| Band, Material, Orthodontic | Dentaurum GmbH & Co. KG | 8 |
| 3M™ Unitek™ | 3M Unitek | 3 |
| Tofflemire Matrix Bands Thin N°14 | Produits dentaires S.A. | 1 |
Showing 12 of 41. All products under Band, Material, 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.