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510(k) K162890

BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment by Straumann USA, LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2017
Date Received
October 17, 2016
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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