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FDA 510(k) Application Details - K083869
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K083869
Device Name
Implant, Endosseous, Root-Form
Applicant
BTLOCK SRL
VIA MADONNETTA 97/C
MONTECCHIO MAGGIORE, VICENZA 36075 IT
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Contact
ESTHER BATTILANA
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Regulation Number
872.3640
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Classification Product Code
DZE
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More FDA Info for this Product Code
Date Received
12/29/2008
Decision Date
03/27/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K083869
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