K113554 is an FDA 510(k) clearance for the CMI IMPLANT IS SYSTEM. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Neobiotech Co., Ltd. (Brea, US). The FDA issued a Cleared decision on April 5, 2012, 126 days after receiving the submission on December 1, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K113554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2011 |
| Decision Date | April 05, 2012 |
| Days to Decision | 126 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE - Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |