FDA 510(k) Application Details - K120776

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K120776
Device Name Abutment, Implant, Dental, Endosseous
Applicant BIOMET 3I
4555 RIVERSIDE DR.
Palm Bch Gdns, FL 33410 US
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Contact TAMARA WEST
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 03/14/2012
Decision Date 09/11/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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