Dandy Ceramic Stain and Glaze— 510(k) K262195

Name: FDA 510(k) clearance K262195
Creator: U.S. Food and Drug Administration
Published: 2026-06-30

Substantially Equivalent

Zima International Inc., dba Dandy

FDA 510(k) clearance K262195 for Dandy Ceramic Stain and Glaze, Substantially Equivalent on 2026-06-30. Applicant: Zima International Inc., dba Dandy. Device class: 2.

Clearance details

Applicant: Zima International Inc., dba Dandy
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2026-06-29
Decision date: 2026-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.