K160991 is an FDA 510(k) clearance for the Neo GBR System. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by Neobiotech Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 10, 2017, 277 days after receiving the submission on April 8, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K160991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2016 |
| Decision Date | January 10, 2017 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZL - Screw, Fixation, Intraosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4880 |