K102015 is an FDA 510(k) clearance for the OSTEON, OSTEON SINUS, OSTEON LIFTING. This device is classified as a Bone Grafting Material, Synthetic (Class II - Special Controls, product code LYC).
Submitted by Genoss Co., Ltd. (Cypress, US). The FDA issued a Cleared decision on November 19, 2010, 126 days after receiving the submission on July 16, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3930. A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw..
| 510(k) Number | K102015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2010 |
| Decision Date | November 19, 2010 |
| Days to Decision | 126 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LYC - Bone Grafting Material, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3930 |
| Definition | A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw. |