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510(k) K112517

ULTRASEAL XT HYDRO by Ultradent Products, Inc. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2011
Date Received
August 31, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
Review Panel
DE
Submission Type

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