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FDA 510(k) Application Details - K101849
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K101849
Device Name
Implant, Endosseous, Root-Form
Applicant
BICON, LLC
501 ARBORWAY
BOSTON, MA 02130 US
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Contact
VINCENT MORGAN, D.M.D.
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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
07/01/2010
Decision Date
10/01/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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