FDA 510(k)

DenMat Multilayered Zirconia Disc

K-Number: K251593 · 2025-08-25

Decision Date2025-08-25

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DenMat Multilayered Zirconia Disc is a medical device manufactured by Denmat Holding, LLC. It received FDA 510(k) clearance on 2025-08-25 under approval number K251593. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DenMat Multilayered Zirconia Disc?

DenMat Multilayered Zirconia Disc is a medical device that received FDA 510(k) clearance on 2025-08-25. It is manufactured by Denmat Holding, LLC. The 510(k) number is K251593.

When was DenMat Multilayered Zirconia Disc approved by the FDA?

DenMat Multilayered Zirconia Disc received FDA 510(k) clearance on 2025-08-25, under approval number K251593.

What company makes DenMat Multilayered Zirconia Disc?

DenMat Multilayered Zirconia Disc is manufactured by Denmat Holding, LLC.

What is the FDA product code for DenMat Multilayered Zirconia Disc?

The FDA product code for DenMat Multilayered Zirconia Disc is EIH.

Related Clinical Trials

NCT07521501 Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design NOT_YET_RECRUITING

Other Devices by Denmat Holding, LLC

K222357DenMat Glutaraldehyde Desensitizer

Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160203ADAMANT ZIRCONIA DISCAdamant Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.