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FDA 510(k) Application Details - K021416
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K021416
Device Name
Material, Impression
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
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/03/2002
Decision Date
05/13/2002
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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