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FDA 510(k) Application Details - K063714
Device Classification Name
Material, Tooth Shade, Resin
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510(K) Number
K063714
Device Name
Material, Tooth Shade, Resin
Applicant
TRI DENTAL INNOVATORS
13902 WEST ST., UNIT C
GARDEN GROVE, CA 92843 US
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Contact
LINDA NGUYEN
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Regulation Number
872.3690
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Classification Product Code
EBF
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More FDA Info for this Product Code
Date Received
12/14/2006
Decision Date
01/31/2007
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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