KGuard Pro
Mouthguard Purple
16manufacturers in China registered for this device type
10catalogue 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 | Ortho-Tain, Inc., United States |
|---|---|
| FDA product code | DYO |
| Device type | Band, Material, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-09 |
| Record revised | 2025-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2025-03-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MOUTHGUARD | In distribution | |
| MOUTHGUARD | In distribution | |
| MOUTHGUARD | In distribution | |
| MOUTHGUARD | In distribution | |
| MOUTHGUARD | In distribution | |
| MOUTHGUARD | Withdrawn | |
| MOUTHGUARD | Withdrawn | |
| MOUTHGUARD | Withdrawn | |
| MOUTHGUARD | Withdrawn | |
| MOUTHGUARD | Withdrawn |
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 |
| 3M™ Unitek™ Lingual Sheaths | 3M Unitek | 21 |
| 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.