FDA 510(k) Application Details - K142880

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K142880
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant Daville Materials LLC
3420 Fostoria Way Suite A-200
San Ramon, CA 94583 US
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Contact Dong Hua
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 10/02/2014
Decision Date 02/04/2015
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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