K262195
- 510(k) number
- K262195
- Device name
- Dandy Ceramic Stain and Glaze
- Applicant
- Zima International Inc., dba Dandy NY · US
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2026-06-30
- Date received
- 2026-06-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K262195.pdf
Official FDA record: K262195
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.