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510(k) K150814

Straumann Screw-Retained Abutment by Straumann USA, LLC — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2015
Date Received
March 27, 2015
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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