Dental Zirconia Ceramic— 510(k) K222626

Name: FDA 510(k) clearance K222626
Creator: U.S. Food and Drug Administration
Published: 2022-12-06

Substantially Equivalent

Aidite (Qinhuangdao) Technology Co., Ltd.

FDA 510(k) clearance K222626 for Dental Zirconia Ceramic, Substantially Equivalent on 2022-12-06. 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: 2022-08-31
Decision date: 2022-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qinhuangdao, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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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

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

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K253036 — Light-curing Coloring Materials (ALCM)2026-04-06
K251415 — Additively Manufactured Aligner Resin2025-08-27
K250534 — Biomic Color Opaque2025-05-20
K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin2025-04-30
K250811 — Dental Zirconia Ceramic2025-04-11

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