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FDA 510(k) Application Details - K140806
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K140806
Device Name
Implant, Endosseous, Root-Form
Applicant
INNOBIOSURG CO., LTD
12226 WASHINGTON LANE
PARKER, AZ 85344 US
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Contact
CHARLIE MACK
Other 510(k) Applications for this Contact
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
04/01/2014
Decision Date
03/23/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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