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FDA 510(k) Application Details - K133850
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K133850
Device Name
Material, Tooth Shade, Resin
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DRIVE, STE IJK
IRVINE, CA 92612 US
Other 510(k) Applications for this Company
Contact
ARMIN ZEHTABCHI
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
12/19/2013
Decision Date
06/04/2014
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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