K230091 is an FDA 510(k) clearance for the THE Cover. This device is classified as a Barrier, Animal Source, Intraoral (Class II - Special Controls, product code NPL).
Submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 6, 2023, 267 days after receiving the submission on January 12, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3930. An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants..
| 510(k) Number | K230091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2023 |
| Decision Date | October 06, 2023 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NPL - Barrier, Animal Source, Intraoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3930 |
| Definition | An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants. |