Home / 510(k) Clearances / K152959

510(k) K152959

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes by Sybron Dental Specialties — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2016
Date Received
October 7, 2015
Clearance Type
Special
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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