K032708 is an FDA 510(k) clearance for the PLASTALGIN AND PLASTALGIN ORTHO. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Septodont (Washington, US). The FDA issued a Cleared decision on November 20, 2003, 79 days after receiving the submission on September 2, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K032708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2003 |
| Decision Date | November 20, 2003 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |