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510(k) K130572

INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM by Implant Direct Sybron Manufacturing, LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2013
Date Received
March 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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