Dental Glass Ceramics Blocks (HT,LT,ST)— 510(k) K241715

Name: FDA 510(k) clearance K241715
Creator: U.S. Food and Drug Administration
Published: 2024-07-12

Substantially Equivalent

Aidite (Qinhuangdao) Technology Co., Ltd.

FDA 510(k) clearance K241715 for Dental Glass Ceramics Blocks (HT,LT,ST), Substantially Equivalent on 2024-07-12. Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
Product code: Product code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2024-06-14
Decision date: 2024-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Qinhuangdao, CN

Download summary PDF View on FDA.gov ↗

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

More clearances from Aidite (Qinhuangdao) Technology Co., Ltd.

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K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin2025-04-30
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Data sourced from openFDA. This site is unofficial and independent of the FDA.