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510(k) K151150

Elements by Pac-Dent International, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2015
Date Received
April 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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