FDA 510(k) Application Details - K150199

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K150199
Device Name Implant, Endosseous, Root-Form
Applicant JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S
AVE JUSCELINO KUBITSCHEK DE
OLIVEIRA 3291-CIC
CURITIBA 81270 BR
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Contact Jacson Cambruzzi
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 01/29/2015
Decision Date 06/15/2015
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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