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510(k) K160345

Glass Ionomer Cement by Shandong Huge Dental Material Corporation — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2017
Date Received
February 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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