
Denmat Holding, LLC
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DenMat Multilayered Zirconia Disc is an FDA 510(k)-cleared medical device (K251593) manufactured by Denmat Holding, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 2025. Regulation: 8.