K163714 is an FDA 510(k) clearance for the OSSIX BONE. This device is classified as a Bone Grafting Material, Animal Source (Class II - Special Controls, product code NPM).
Submitted by Datum Dental, Ltd. (Lod, IL). The FDA issued a Cleared decision on July 18, 2017, 200 days after receiving the submission on December 30, 2016.
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 | K163714 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2016 |
| Decision Date | July 18, 2017 |
| Days to Decision | 200 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. |