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FDA 510(k) Application Details - K170080
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K170080
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
JJGC Industria e Comercio de Materiais Dentarios SA
Av. Juscelino Kubitschek de Oliveira, 3291 û CIC
Curitiba 81270-200 BR
Other 510(k) Applications for this Company
Contact
Julianne Lechechem
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2017
Decision Date
11/02/2017
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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