K062506 is an FDA 510(k) clearance for the INCORIS AL. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on September 8, 2006, 11 days after receiving the submission on August 28, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K062506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2006 |
| Decision Date | September 08, 2006 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |