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FDA 510(k) Application Details - K130991
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K130991
Device Name
Powder, Porcelain
Applicant
SAGEMAX BIOCERAMICS, INC.
34210 9th Ave S Suite 118
Federal Way, WA 98003 US
Other 510(k) Applications for this Company
Contact
JOSE E CABRERA
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/10/2013
Decision Date
02/10/2014
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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