Luminesse Multi-Layer Pmma Discs
Catalogue number 5320D4, listed by Talladium, Inc., United States, under Coating, Denture Hydrophilic, Resin. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Henan.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
Record
| Listed by | Talladium, Inc., United States |
|---|---|
| FDA product code | EBE |
| Device type | Coating, Denture Hydrophilic, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3300 |
| Establishment | Manufacturer |
| 510(k) | K142371 |
| Record published | 2016-10-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5320D4 | In distribution |
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.