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FDA 510(k)

Dandy Ceramic Stain and Glaze

K-Number: K262195 · 2026-06-30

ApplicantZima International Inc., dba Dandy
Decision Date2026-06-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dandy Ceramic Stain and Glaze is the device name listed in this FDA 510(k) record. The listed applicant is Zima International Inc., dba Dandy. It received FDA 510(k) clearance on 2026-06-30 under 510(k) number K262195. 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 Dandy Ceramic Stain and Glaze?

Dandy Ceramic Stain and Glaze is a medical device that received FDA 510(k) clearance on 2026-06-30. The listed applicant is Zima International Inc., dba Dandy. The 510(k) number is K262195.

When did Dandy Ceramic Stain and Glaze receive FDA 510(k) clearance?

Dandy Ceramic Stain and Glaze received FDA 510(k) clearance on 2026-06-30, under 510(k) number K262195.

Who is the listed applicant for Dandy Ceramic Stain and Glaze?

The FDA 510(k) record lists Zima International Inc., dba Dandy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dandy Ceramic Stain and Glaze?

The FDA product code for Dandy Ceramic Stain and Glaze 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.K260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbHK260067Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation

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.

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