K140806 is an FDA 510(k) clearance for the IBS IMPLANT SYSTEM. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Innobiosurg Co., Ltd. (Echo, US). The FDA issued a Cleared decision on March 23, 2015, 356 days after receiving the submission on April 1, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K140806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2014 |
| Decision Date | March 23, 2015 |
| Days to Decision | 356 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZE - Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |