K191737 is an FDA 510(k) clearance for the The Graft Bone Substitute. This device is classified as a Bone Grafting Material, Animal Source (Class II - Special Controls, product code NPM).
Submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on February 14, 2020, 231 days after receiving the submission on June 28, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3930. A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw..
| 510(k) Number | K191737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2019 |
| Decision Date | February 14, 2020 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NPM - Bone Grafting Material, Animal Source |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3930 |
| Definition | A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw. |