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510(k) K200175

DIA-ROOT BIO Sealer by DiaDent Group International — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2020
Date Received
January 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type

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