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FDA 510(k) Application Details - K093749
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K093749
Device Name
Implant, Endosseous, Root-Form
Applicant
GC AMERICA, INC.
10 E. SCRANTON AVENUE
SUITE 201
LAKE BLUFF, IL 60044 US
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Contact
CARL JENKINS
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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
12/07/2009
Decision Date
12/06/2010
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
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