DenMat Multilayered Zirconia Disc— 510(k) K251593

Name: FDA 510(k) clearance K251593
Creator: U.S. Food and Drug Administration
Published: 2025-08-25

Substantially Equivalent

Denmat Holding, LLC

FDA 510(k) clearance K251593 for DenMat Multilayered Zirconia Disc, Substantially Equivalent on 2025-08-25. Applicant: Denmat Holding, LLC. Device class: 2.

Clearance details

Applicant: Denmat Holding, LLC
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2025-05-27
Decision date: 2025-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lompoc, CA, US

Download summary PDF View on FDA.gov ↗

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K260918 — Zolid Lunaris2026-06-29

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Data sourced from openFDA. This site is unofficial and independent of the FDA.