510(k) K173975

UF(II) Wide Fixture by Dio Corporation — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2018
Date Received
December 29, 2017
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