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FDA 510(k) Application Details - K152004
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K152004
Device Name
Material, Tooth Shade, Resin
Applicant
NANOVA BIOMATERIALS INC
3806 MOJAVE CT
COLUMBIA, MO 65202 US
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Contact
ANDREW RITTS
Other 510(k) Applications for this Contact
Regulation Number
872.3690
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Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/20/2015
Decision Date
11/17/2015
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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