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FDA 510(k) Application Details - K171330
Device Classification Name
Sealant, Pit And Fissure, And Conditioner
More FDA Info for this Device
510(K) Number
K171330
Device Name
Sealant, Pit And Fissure, And Conditioner
Applicant
Nanova Biomaterials Inc
3806 Mojave Ct
Columbia, MO 65202 US
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Contact
Andrew C. Ritts
Other 510(k) Applications for this Contact
Regulation Number
872.3765
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Classification Product Code
EBC
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More FDA Info for this Product Code
Date Received
05/05/2017
Decision Date
09/08/2017
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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