510(k) K170950

Well-Root ST by Vericom Co., Ltd. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2017
Date Received
March 31, 2017
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