Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)— 510(k) K240672

Name: FDA 510(k) clearance K240672
Creator: U.S. Food and Drug Administration
Published: 2024-06-07

Substantially Equivalent

Zhejiang Zahndent Biotechnology Co., Ltd.

FDA 510(k) clearance K240672 for Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML), Substantially Equivalent on 2024-06-07. Applicant: Zhejiang Zahndent Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Zahndent Biotechnology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2024-03-11
Decision date: 2024-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taizhou, CN

Download summary PDF View on FDA.gov ↗

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