K110198 is an FDA 510(k) clearance for the BLUE SKY BIO TCP. This device is classified as a Bone Grafting Material, Synthetic (Class II - Special Controls, product code LYC).
Submitted by Blue Sky Bio, LLC (Grayslake, US). The FDA issued a Cleared decision on December 22, 2011, 332 days after receiving the submission on January 24, 2011.
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 | K110198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2011 |
| Decision Date | December 22, 2011 |
| Days to Decision | 332 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. |