K192042 is an FDA 510(k) clearance for the Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal. This device is classified as a Barrier, Animal Source, Intraoral (Class II - Special Controls, product code NPL).
Submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on August 29, 2019, 29 days after receiving the submission on July 31, 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 | K192042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2019 |
| Decision Date | August 29, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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. |