K033767 is an FDA 510(k) clearance for the DUAL TOP ANCHOR SYSTEM SCREWS. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Jeil Medical Corporation (Deer Field, US). The FDA issued a Cleared decision on February 24, 2004, 83 days after receiving the submission on December 3, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K033767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2003 |
| Decision Date | February 24, 2004 |
| Days to Decision | 83 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 |