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FDA 510(k) Application Details - K173575
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K173575
Device Name
Implant, Endosseous, Root-Form
Applicant
OsteoReady LLC
150 Baker Ave. Ext. Ste. 110
Concord, MA 01742 US
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Contact
Robert Gottlander
Other 510(k) Applications for this Contact
Regulation Number
872.3640
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Classification Product Code
DZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/20/2017
Decision Date
08/17/2018
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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