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FDA 510(k) Application Details - K182620
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K182620
Device Name
Implant, Endosseous, Root-Form
Applicant
JJGC Industria e Comercio de Materiais Dentarios SA
Av. P. Juscelino Kubitschek de Oliveira, 3291
Curitiba 81270-200 BR
Other 510(k) Applications for this Company
Contact
Julianne Lachechem
Other 510(k) Applications for this Contact
Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
DZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/2018
Decision Date
01/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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