A-Silicone for Bite Registration— 510(k) K201684

Name: FDA 510(k) clearance K201684
Creator: U.S. Food and Drug Administration
Published: 2020-09-24

Substantially Equivalent

Shandong Huge Dental Material Corporation

FDA 510(k) clearance K201684 for A-Silicone for Bite Registration, Substantially Equivalent on 2020-09-24. Applicant: Shandong Huge Dental Material Corporation. Device class: 2.

Clearance details

Applicant: Shandong Huge Dental Material Corporation
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2020-06-22
Decision date: 2020-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, 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.