Dandy Ceramic Stain and Glaze— 510(k) K262195
Substantially EquivalentZima 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.
Summary
Dandy Ceramic Stain and Glaze is from Zima International, doing business as Dandy, and is filed under EIH, porcelain powder. The record doesn't describe the product beyond its name and the code name.
Class II, 21 CFR 872.6660. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from New York, New York. The decision came 1 calendar day after FDA received it (June 29 to June 30, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Zima International Inc., dba Dandy
- Product code
- Product code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code EIH
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