ICE Ceramics, ICE Stains, Fresco— 510(k) K213722

Name: FDA 510(k) clearance K213722
Creator: U.S. Food and Drug Administration
Published: 2022-12-14

Substantially Equivalent

Zirkonzahn Srl

FDA 510(k) clearance K213722 for ICE Ceramics, ICE Stains, Fresco, Substantially Equivalent on 2022-12-14. Applicant: Zirkonzahn Srl. Device class: 2.

Clearance details

Applicant: Zirkonzahn Srl
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2021-11-26
Decision date: 2022-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gais, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

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K200676 — ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA2020-07-08
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Data sourced from openFDA. This site is unofficial and independent of the FDA.