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510(k) K112045

SIMPLELINE II ABUTMENT SYSTEM by Dentium Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2012
Date Received
July 18, 2011
Clearance Type
Abbreviated
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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  • K161713 — Dentium CAD/CAM Abutments (December 16, 2016)

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