FDA 510(k)

Dandy Ceramic Stain and Glaze

Numéro K : K262195 · 2026-06-30

DemandeurZima International Inc., dba Dandy

Date de décision2026-06-30

Code produitEIH

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : EIH)

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

Source officielle

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