FDA 510(k) Application Details - K133510

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K133510
Device Name Implant, Endosseous, Root-Form
Applicant JJ INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
11264 EL CAMINO REAL, SUITE 400
SAN DIEGO, CA 92130 US
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Contact KEVIN A THOMAS
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 11/14/2013
Decision Date 02/24/2014
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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