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FDA 510(k) Application Details - K101607
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K101607
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
BIOMET 3I, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
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Contact
JOSE E CABRERA
Other 510(k) Applications for this Contact
Regulation Number
872.3630
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Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
06/08/2010
Decision Date
03/11/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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