K030588 is an FDA 510(k) clearance for the ARTEGRAL AND POLYSTAR SELECTION. This device is classified as a Denture, Plastic, Teeth (Class II - Special Controls, product code ELM).
Submitted by Merz Dental GmbH (Concord, US). The FDA issued a Cleared decision on May 7, 2003, 71 days after receiving the submission on February 25, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3590.
| 510(k) Number | K030588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2003 |
| Decision Date | May 07, 2003 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELM — Denture, Plastic, Teeth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3590 |