FDA 510(k) Application Details - K072978

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K072978
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant MICERIUM S.P.A.
VIA MARCONI 83
AVEGNO, GENOA 16030 IT
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Contact EUGENIO MICELI
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 10/22/2007
Decision Date 01/17/2008
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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