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510(k) K152956

Pulp Canal Sealer, Pulp Canal Sealer EWT by Sybron Dental Specialties — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2016
Date Received
October 7, 2015
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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