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510(k) K112730

ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION by Biomet 3i — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2012
Date Received
September 20, 2011
Clearance Type
Special
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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