FDA 510(k) Application Details - K053089

Device Classification Name Sealant, Pit And Fissure, And Conditioner

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510(K) Number K053089
Device Name Sealant, Pit And Fissure, And Conditioner
Applicant CAO GROUP, INC.
8683 SOUTH 700 WEST
SANDY, UT 84070 US
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Contact ROBERT K LARSEN
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Regulation Number 872.3765

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Classification Product Code EBC
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Date Received 11/02/2005
Decision Date 12/20/2005
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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