zirkon; structure; LFU shades, stains and glazes— 510(k) K251084

Name: FDA 510(k) clearance K251084
Creator: U.S. Food and Drug Administration
Published: 2025-06-05

Substantially Equivalent

Estetic Ceram AG

FDA 510(k) clearance K251084 for zirkon; structure; LFU shades, stains and glazes, Substantially Equivalent on 2025-06-05. Applicant: Estetic Ceram AG. Device class: 2.

Clearance details

Applicant: Estetic Ceram AG
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2025-04-09
Decision date: 2025-06-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Triesen, LI

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

view all

K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30
K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

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