510(k) K190091

Diapaste by DiaDent Group International — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2020
Date Received
January 18, 2019
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