FDA 510(k) Application Details - K222026

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K222026
Device Name Abutment, Implant, Dental, Endosseous
Applicant JJGC Industria e Comercio de Materiais Dentarios S.A.
Av. Juscelino Kubitschek de Oliveira, 3291 - CIC
Curitiba 81270-200 BR
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Contact Barbara Uzae
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 07/11/2022
Decision Date 07/14/2023
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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