The Orthodontic Store
Disc Guard
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Weihai Jieshi Commodity Manufacture Co., Ltd. | Weihai | Shandong | Manufacturer | 10 |
| Ascend Excellence Daily Products Jiangsu Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Young Innovations Inc., United States |
|---|---|
| FDA product code | EEJ |
| Device type | Guard, Disk |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Packaging | Inner |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 299-400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Guard, Disk | Dentaurum GmbH & Co. KG | 8 |
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.