Zolid Lunaris— 510(k) K260918

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.

Clearance details

Applicant: Amann Girrbach AG
Product code: 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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More clearances from Amann Girrbach AG

K191836 — Ceramill A-Splint2019-12-20
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Data sourced from openFDA. This site is unofficial and independent of the FDA.