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FDA 510(k) Application Details - K983453
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K983453
Device Name
Powder, Porcelain
Applicant
NOBEL BIOCARE UAS INC
777 OAKMONT LANE, SUITE 100
WESTMONT, IL 60559 US
Other 510(k) Applications for this Company
Contact
BETSY A BROWN
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
09/30/1998
Decision Date
11/18/1998
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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