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510(k) K170838

Medentika CAD/CAM TiBases by Medentika GmbH — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2017
Date Received
March 21, 2017
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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