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FDA 510(k) Application Details - K143022
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K143022
Device Name
Implant, Endosseous, Root-Form
Applicant
BIOHORIZONS IMPLANT SYSTEMS, INC.
2300 RIVERCHASE CENTER
BIRMINGHAM, AL 35244 US
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Contact
Michael Davis
Other 510(k) Applications for this Contact
Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
DZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/2014
Decision Date
01/08/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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