K801208 is an FDA 510(k) clearance for the HOLLOW BASKET TITANIUM DENTAL IMPLANT. This device is classified as a Implant, Subperiosteal (Class II - Special Controls, product code ELE).
Submitted by Colmed, Ltd. (Walker, US). The FDA issued a Cleared decision on May 28, 1980, 8 days after receiving the submission on May 20, 1980.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3645.
| 510(k) Number | K801208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 1980 |
| Decision Date | May 28, 1980 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ELE — Implant, Subperiosteal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3645 |