FDA 510(k) Application Details - K060063

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K060063
Device Name Abutment, Implant, Dental, Endosseous
Applicant IMPLANT DIRECT LLC
27030 MALIBU HILLS RD.
CALABASAS HILLS, CA 91301 US
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Contact ROSEMARIE MASTELLER
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 01/09/2006
Decision Date 05/19/2006
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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