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510(k) K211905

UltraCal XS by Ultradent Products, Inc. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2021
Date Received
June 21, 2021
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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