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510(k) K090630

NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) by Nobel Biocare AB — Product Code FZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2009
Date Received
March 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
Review Panel
SU
Submission Type

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