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FDA 510(k) Application Details - K081405
Device Classification Name
Cement, Dental
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510(K) Number
K081405
Device Name
Cement, Dental
Applicant
DOXA DENTAL AB
555 THIRTEENTH STREET NW
COLUMBIA SQUARE
WASHINGTON, DC 20004 US
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Contact
JONATHAN KAHAN
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Regulation Number
872.3275
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Classification Product Code
EMA
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More FDA Info for this Product Code
Date Received
05/19/2008
Decision Date
08/21/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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