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FDA 510(k) Application Details - K191751
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K191751
Device Name
Implant, Endosseous, Root-Form
Applicant
Hiossen, Inc.
85 Ben Fairless Drive
Fairless Hills, PA 19030 US
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Contact
Peter Lee
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
07/01/2019
Decision Date
12/16/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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