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510(k) K152243

One Coat 7 Universal by Coltene/Whaledent AG — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2015
Date Received
August 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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