Glass Ionomer Cement

Cement, Dental

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 Glass Ionomer Cement.

Pre-market Notification Details

Device IDK160345
510k NumberK160345
Device Name:Glass Ionomer Cement
ClassificationCement, Dental
Applicant SHANDONG HUGE DENTAL MATERIAL CORPORATION No. 68 Shanhai Road, Donggang District Rizhao City,  CN 276800
ContactSteven Song
CorrespondentSteven Song
SHANDONG HUGE DENTAL MATERIAL CORPORATION No. 68 Shanhai Road, Donggang District Rizhao City,  CN 276800
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-08
Decision Date2017-03-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970402670269 K160345 000
06970402670245 K160345 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.