FDA 510(k) Application Details - K102209

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K102209
Device Name Abutment, Implant, Dental, Endosseous
Applicant BIOMET 3I, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
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Contact SIMEON SIMONE
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 08/05/2010
Decision Date 12/03/2010
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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