Zolid Lunaris— 510(k) K260918

Name: FDA 510(k) clearance K260918
Creator: U.S. Food and Drug Administration
Published: 2026-06-29

Substantially Equivalent

Amann Girrbach AG

FDA 510(k) clearance K260918 for Zolid Lunaris, Substantially Equivalent on 2026-06-29. Applicant: Amann Girrbach AG. Device class: 2.

Summary

Zolid Lunaris from Amann Girrbach is filed under EIH, porcelain powder. The record doesn't describe the material beyond the product name and the code name.

Class II, 21 CFR 872.6660. Dental is both the classification panel and the review panel. The submission was a Traditional 510(k).

Amann Girrbach filed from Maeder, Austria. The decision came 102 calendar days after receipt (March 19 to June 29, 2026).

Clearance details

Applicant: Amann Girrbach AG
Product code: Product code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2026-03-19
Decision date: 2026-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maeder, AT

Download summary PDF View on FDA.gov ↗

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