A-Silicone For Bite Registration

Material, Impression

Shandong Huge Dental Material Corporation

The following data is part of a premarket notification filed by Shandong Huge Dental Material Corporation with the FDA for A-silicone For Bite Registration.

Pre-market Notification Details

Device IDK201684
510k NumberK201684
Device Name:A-Silicone For Bite Registration
ClassificationMaterial, Impression
Applicant Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City,  CN 276800
ContactMaggie Zheng
CorrespondentMaggie Zheng
Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City,  CN 276800
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-22
Decision Date2020-09-24

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