PMMA BLOCK— 510(k) K223706

Name: FDA 510(k) clearance K223706
Creator: U.S. Food and Drug Administration
Published: 2023-05-12

Substantially Equivalent

Huliang(Shanghai) Bio-Tech Co., Ltd.

FDA 510(k) clearance K223706 for PMMA BLOCK, Substantially Equivalent on 2023-05-12. Applicant: Huliang(Shanghai) Bio-Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huliang(Shanghai) Bio-Tech Co., Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2022-12-12
Decision date: 2023-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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