K120601 is an FDA 510(k) clearance for the GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O. This device is classified as a Bone Grafting Material, Animal Source (Class II - Special Controls, product code NPM).
Submitted by Geistlich Pharma AG (Washington, US). The FDA issued a Cleared decision on May 24, 2012, 86 days after receiving the submission on February 28, 2012.
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 | K120601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2012 |
| Decision Date | May 24, 2012 |
| Days to Decision | 86 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. |