K251084 is an FDA 510(k) clearance for the zirkon. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Estetic Ceram AG (Triesen, LI). The FDA issued a Cleared decision on June 5, 2025, 57 days after receiving the submission on April 9, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K251084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2025 |
| Decision Date | June 05, 2025 |
| Days to Decision | 57 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH - Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |