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FDA 510(k) Application Details - K082158
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K082158
Device Name
Powder, Porcelain
Applicant
XPDENT CORP
12145 SW 131 AVENUE
MIAMI, FL 33186 US
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Contact
CARMEN PEREZ
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
07/31/2008
Decision Date
10/15/2008
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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