K060501 is an FDA 510(k) clearance for the IMPLANTIUM II. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Dentium Co., Ltd. (Dunwoody, US). The FDA issued a Cleared decision on June 16, 2006, 112 days after receiving the submission on February 24, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K060501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2006 |
| Decision Date | June 16, 2006 |
| Days to Decision | 112 days |
| Submission Type | Abbreviated |
| 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 |