FDA 510(k)

KDF Zirconia Disc

K-Number: K221429 · 2022-07-14

Decision Date2022-07-14

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

KDF Zirconia Disc is the device name listed in this FDA 510(k) record. The listed applicant is Denken-Highdental Co., Ltd.. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K221429. 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 KDF Zirconia Disc?

KDF Zirconia Disc is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Denken-Highdental Co., Ltd.. The 510(k) number is K221429.

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

KDF Zirconia Disc received FDA 510(k) clearance on 2022-07-14, under 510(k) number K221429.

Who is the listed applicant for KDF Zirconia Disc?

The FDA 510(k) record lists Denken-Highdental Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KDF Zirconia Disc?

The FDA product code for KDF Zirconia Disc is EIH.

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 Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

Official Source

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