FDA 510(k) Application Details - K072830

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K072830
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant PENTRON CLINICAL TECHNOLOGIES
68-70 NORTH PLAINS INDUSTRIAL
ROAD
WALLINGFORD, CT 06492 US
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Contact GREG MOREAU
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 10/03/2007
Decision Date 12/04/2007
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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