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510(k) K172100

URIS OMNI System by Truabutment, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2018
Date Received
July 11, 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

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  • K200817 — URIS OMNI Narrow System & Prosthetic (October 7, 2020)

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