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FDA 510(k) Application Details - K072425
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K072425
Device Name
Implant, Endosseous, Root-Form
Applicant
GC AMERICA, INC.
1025 EVERETT ROAD, SUITE 100
LAKE FOREST, IL 60045 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
08/29/2007
Decision Date
03/10/2008
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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