FDA 510(k) Application Details - K101945

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K101945
Device Name Implant, Endosseous, Root-Form
Applicant JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO, CA 92130 US
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Contact LINDA K SCHULZ
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 07/12/2010
Decision Date 01/26/2011
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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