Dental Impression Material— 510(k) K221668

Name: FDA 510(k) clearance K221668
Creator: U.S. Food and Drug Administration
Published: 2022-08-08

Substantially Equivalent

Chemoment Materials Co.,Ltd

FDA 510(k) clearance K221668 for Dental Impression Material, Substantially Equivalent on 2022-08-08. Applicant: Chemoment Materials Co.,Ltd. Device class: 2.

Clearance details

Applicant: Chemoment Materials Co.,Ltd
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2022-06-08
Decision date: 2022-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hefei, 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.