Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank— 510(k) K212259

Name: FDA 510(k) clearance K212259
Creator: U.S. Food and Drug Administration
Published: 2021-11-12

Substantially Equivalent

Zirdent New Material Co., Ltd.

FDA 510(k) clearance K212259 for Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Substantially Equivalent on 2021-11-12. Applicant: Zirdent New Material Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zirdent New Material Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2021-07-20
Decision date: 2021-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, 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

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