Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank— 510(k) K180252

Name: FDA 510(k) clearance K180252
Creator: U.S. Food and Drug Administration
Published: 2018-04-24

Substantially Equivalent

Crown Porcelain Dental Technology Co., Ltd.

FDA 510(k) clearance K180252 for Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank, Substantially Equivalent on 2018-04-24. Applicant: Crown Porcelain Dental Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Crown Porcelain Dental Technology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2018-01-30
Decision date: 2018-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, 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

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