FDA 510(k) Application Details - K130476

Device Classification Name Implant, Endosseous, Orthodontic

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510(K) Number K130476
Device Name Implant, Endosseous, Orthodontic
Applicant DENTAL MORELLI
18851 NE 29TH AVE 720
AVENTURA, FL 33180 US
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Contact LILIAN LLULL
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Regulation Number 872.3640

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Classification Product Code OAT
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Date Received 02/25/2013
Decision Date 01/08/2014
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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