FDA 510(k) Application Details - K133733

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K133733
Device Name Implant, Endosseous, Root-Form
Applicant BIOSAF IN S.R.L.
VIA A. ALTOBELLI BONETTI, 3/A
IMOLA, BO 40026 IT
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Contact MAURIZIO PANTALEONI
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 12/06/2013
Decision Date 01/28/2015
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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