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FDA 510(k) Application Details - K033553
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K033553
Device Name
Powder, Porcelain
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK, PA 17405-0872 US
Other 510(k) Applications for this Company
Contact
P. JEFFERY LEHN
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
11/10/2003
Decision Date
12/02/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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