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FDA 510(k) Application Details - K000680
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K000680
Device Name
Powder, Porcelain
Applicant
MIDATLANTIC DIVISION OF DENTREX, INC.
600 DEER RD.
SUITE 3
CHERRY HILL, NJ 08034 US
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Contact
LAURANCE W POWELL
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
02/29/2000
Decision Date
05/25/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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