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FDA 510(k) Application Details - K060104
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K060104
Device Name
Powder, Porcelain
Applicant
GLIDEWELL LABORATORIES
4141 MACARTHUR BLVD.
NEWPORT BEACH, CA 92660 US
Other 510(k) Applications for this Company
Contact
KEITH D ALLRED
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
01/13/2006
Decision Date
03/15/2006
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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