K253953 is an FDA 510(k) clearance for the IPS e.max Zirconia. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on March 10, 2026, 90 days after receiving the submission on December 10, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K253953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2025 |
| Decision Date | March 10, 2026 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |