510(k) K202452

NobelProcera Zirconia Implant Bridge by Nobel Biocare AB — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2020
Date Received
August 27, 2020
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.