DD Hybridlayer (multicolored zirconia)— 510(k) K241579

Name: FDA 510(k) clearance K241579
Creator: U.S. Food and Drug Administration
Published: 2024-09-06

Substantially Equivalent

Dental Direkt GmbH

FDA 510(k) clearance K241579 for DD Hybridlayer (multicolored zirconia), Substantially Equivalent on 2024-09-06. Applicant: Dental Direkt GmbH. Device class: 2.

Clearance details

Applicant: Dental Direkt GmbH
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2024-06-03
Decision date: 2024-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spenge, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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K262239 — Obsidian® Press Over Zirconia2026-07-30
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K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

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