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FDA 510(k) Application Details - K010630
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K010630
Device Name
Powder, Porcelain
Applicant
PROCERA SANDVIK, INC.
1872 MCBRIDE AVE.
FAIR LAWN, NJ 07410-2812 US
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Contact
MARTIN STERNER
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
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More FDA Info for this Product Code
Date Received
03/02/2001
Decision Date
04/17/2001
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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