ELASTIC IMPRESSION MATERIAL— 510(k) K133071

Name: FDA 510(k) clearance K133071
Creator: U.S. Food and Drug Administration
Published: 2014-05-28

Substantially Equivalent

Rizhao Huge Dental Industry Co., Ltd.

FDA 510(k) clearance K133071 for ELASTIC IMPRESSION MATERIAL, Substantially Equivalent on 2014-05-28. Applicant: Rizhao Huge Dental Industry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rizhao Huge Dental Industry Co., Ltd.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2013-09-30
Decision date: 2014-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, US

Download summary PDF View on FDA.gov ↗

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