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FDA 510(k) Application Details - K072100
Device Classification Name
Abutment, Implant, Dental, Endosseous
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510(K) Number
K072100
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
GC AMERICA, INC.
1025 EVERETT ROAD, SUITE 100
LAKE FOREST, IL 60045 US
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Contact
H. CARL JENKINS
Other 510(k) Applications for this Contact
Regulation Number
872.3630
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Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/31/2007
Decision Date
02/14/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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