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

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
Code ELW
Device class
Class 2
Regulation
21 CFR 872.3660
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rizhao City, CN
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