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510(k) K161987

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure by Dio Corporation — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2017
Date Received
July 19, 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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