K043195 is an FDA 510(k) clearance for the NEO IMPLANT SYSTEM. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Neoss, Ltd. (Washington, US). The FDA issued a Cleared decision on March 7, 2005, 109 days after receiving the submission on November 18, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K043195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2004 |
| Decision Date | March 07, 2005 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| 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 |