K100247 is an FDA 510(k) clearance for the DETAX IMPLANTLINK SEMI. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Detax GmbH & Co. KG (Amsterdam, NL). The FDA issued a Cleared decision on July 23, 2010, 177 days after receiving the submission on January 27, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K100247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2010 |
| Decision Date | July 23, 2010 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMA - Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |