FDA 510(k) Application Details - K153624

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K153624
Device Name Abutment, Implant, Dental, Endosseous
Applicant JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S
AV. JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 - CIC
CURTIBA 81270-200 BR
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Contact Jacson Cambruzzi
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 12/18/2015
Decision Date 04/15/2016
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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