Cleared Traditional

DenMat Multilayered Zirconia Disc

K251593 · Denmat Holding, LLC · Dental

Aug 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K251593 is an FDA 510(k) clearance for the DenMat Multilayered Zirconia Disc, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Denmat Holding, LLC (Lompoc, US). The FDA issued a Cleared decision on August 25, 2025, 90 days after receiving the submission on May 27, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K251593 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2025
Decision Date	August 25, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF