K143730 is an FDA 510(k) clearance for the GBR System. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on June 10, 2015, 163 days after receiving the submission on December 29, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K143730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2014 |
| Decision Date | June 10, 2015 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |