Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers…
Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers from penetrating the damaged area. THE Cover induces cell proliferation from the periodontal ligament and alveolar bone.
Who Else Makes It
Concentrated in Beijing (1), Jiangsu (1).
Record
Regulatory record for THE Cover | Listed by | Purgo Biologics Inc., South Korea |
| FDA product code | NPL |
| Device type | Barrier, Animal Source, Intraoral |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3930 |
| Establishment | Manufacturer |
| 510(k) | K230091 |
| Record published | 2023-10-31 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
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.