K121824 is an FDA 510(k) clearance for the ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Lascod Spa (Mt. Airy, US). The FDA issued a Cleared decision on August 23, 2012, 63 days after receiving the submission on June 21, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K121824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2012 |
| Decision Date | August 23, 2012 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |