K090950 is an FDA 510(k) clearance for the BONE PLUS BCP. This device is classified as a Bone Grafting Material, Synthetic (Class II - Special Controls, product code LYC).
Submitted by Megagen Implant Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on July 2, 2010, 455 days after receiving the submission on April 3, 2009.
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 | K090950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2009 |
| Decision Date | July 02, 2010 |
| Days to Decision | 455 days |
| Submission Type | Traditional |
| 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. |