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510(k) K191382

IPS e.max CAD Abutment Solutions- extra systems by Ivoclar Vivadent, AG — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2019
Date Received
May 23, 2019
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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