HYGEDENT ALGINATE IMPRESSION MATERIAL— 510(k) K140074

Name: FDA 510(k) clearance K140074
Creator: U.S. Food and Drug Administration
Published: 2014-05-21

Substantially Equivalent

Hygedent, Inc.

FDA 510(k) clearance K140074 for HYGEDENT ALGINATE IMPRESSION MATERIAL, Substantially Equivalent on 2014-05-21. Applicant: Hygedent, Inc.. Device class: 2.

Clearance details

Applicant: Hygedent, Inc.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2014-01-13
Decision date: 2014-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, Guangdong, 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.