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510(k) K153534

NobelProcera HT ML Full Contour Zirconia Crown by Nobel Biocare AB — Product Code ELL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2016
Date Received
December 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Porcelain
Device Class
Class II
Regulation Number
872.3920
Review Panel
DE
Submission Type

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