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FDA 510(k) Application Details - K152373
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K152373
Device Name
Material, Tooth Shade, Resin
Applicant
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
Spitelgasse 3
Bad Sackingen D-79713 DE
Other 510(k) Applications for this Company
Contact
Bernd Walker
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/21/2015
Decision Date
12/30/2015
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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