K062542 is an FDA 510(k) clearance for the Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Z-Systems AG (San Diego, US). The FDA issued a Cleared decision on October 29, 2007, 425 days after receiving the submission on August 30, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K062542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2006 |
| Decision Date | October 29, 2007 |
| Days to Decision | 425 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 |