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510(k) K161851

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2016
Date Received
July 6, 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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