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FDA 510(k)

DenMat Multilayered Zirconia Disc

K-Number: K251593 · 2025-08-25

ApplicantDenmat Holding, LLC
Decision Date2025-08-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DenMat Multilayered Zirconia Disc is the device name listed in this FDA 510(k) record. The listed applicant is Denmat Holding, LLC. It received FDA 510(k) clearance on 2025-08-25 under 510(k) 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. The listed applicant is Denmat Holding, LLC. The 510(k) number is K251593.

When did DenMat Multilayered Zirconia Disc receive FDA 510(k) clearance?

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

Who is the listed applicant for DenMat Multilayered Zirconia Disc?

The FDA 510(k) record lists Denmat Holding, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Denmat Holding, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222357DenMat Glutaraldehyde Desensitizer

Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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.

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