K192612 is an FDA 510(k) clearance for the Kerecis Gingiva Graft. This device is classified as a Barrier, Animal Source, Intraoral (Class II - Special Controls, product code NPL).
Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on November 13, 2020, 420 days after receiving the submission on September 20, 2019.
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 | K192612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2019 |
| Decision Date | November 13, 2020 |
| Days to Decision | 420 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. |