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FDA 510(k) Application Details - K162960
Device Classification Name
Cement, Dental
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510(K) Number
K162960
Device Name
Cement, Dental
Applicant
ITENA CLINICAL
83 AVENUE FOCH
PARIS 75116 FR
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Contact
Charles Peyre
Other 510(k) Applications for this Contact
Regulation Number
872.3275
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Classification Product Code
EMA
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More FDA Info for this Product Code
Date Received
10/24/2016
Decision Date
03/14/2017
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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