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FDA 510(k) Application Details - K081287
Device Classification Name
Activator, Ultraviolet, For Polymerization
More FDA Info for this Device
510(K) Number
K081287
Device Name
Activator, Ultraviolet, For Polymerization
Applicant
DEN-MAT HOLDINGS, LLC
2727 SKYWAY DR.
SANTA MARIA, CA 93455 US
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Contact
ALAN MATTHEWS
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Regulation Number
872.6070
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Classification Product Code
EBZ
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More FDA Info for this Product Code
Date Received
05/07/2008
Decision Date
11/21/2008
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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