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FDA 510(k) Application Details - K010849
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K010849
Device Name
Material, Tooth Shade, Resin
Applicant
APEX DENTAL MATERIALS, INC.
603 BERKLEY COURT
SCHAUMBURG, IL 60194 US
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Contact
SCOTT LAMERAND
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2001
Decision Date
09/14/2001
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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