Dental porcelain powder— 510(k) K242400

Name: FDA 510(k) clearance K242400
Creator: U.S. Food and Drug Administration
Published: 2024-10-10

Substantially Equivalent

Yilink (Tianjin) Biotechnology Co., Ltd.

FDA 510(k) clearance K242400 for Dental porcelain powder, Substantially Equivalent on 2024-10-10. Applicant: Yilink (Tianjin) Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yilink (Tianjin) Biotechnology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2024-08-13
Decision date: 2024-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

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K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

More clearances from Yilink (Tianjin) Biotechnology Co., Ltd.

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K222513 — Glass Ceramics2023-02-10
K222520 — Zirconia Block2022-11-14

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