K030318 is an FDA 510(k) clearance for the P2 POLYETHER. This device is classified as a Material, Impression (Class II — Special Controls, product code ELW).
Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on April 3, 2003, 63 days after receiving the submission on January 30, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K030318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2003 |
| Decision Date | April 03, 2003 |
| Days to Decision | 63 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 |