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FDA 510(k) Application Details - K010547
Device Classification Name
Agent, Tooth Bonding, Resin
More FDA Info for this Device
510(K) Number
K010547
Device Name
Agent, Tooth Bonding, 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
872.3200
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Classification Product Code
KLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/23/2001
Decision Date
08/16/2001
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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