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510(k) K213063

TLX SRAs and TLX Gold Abutments by Institut Straumann AG — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2022
Date Received
September 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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