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FDA 510(k) Application Details - K103234
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K103234
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
GC AMERICA, INC.
10 E. SCRANTON AVENUE
SUITE 201
LAKE BLUFF, IL 60044 US
Other 510(k) Applications for this Company
Contact
CARL JENKINS
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/02/2010
Decision Date
06/30/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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