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FDA 510(k) Application Details - K193096
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K193096
Device Name
Implant, Endosseous, Root-Form
Applicant
S.I.N. -Sistema de Implante Nacional S.A.
Avenida Vereador Abel Ferreira, 1100
Sao Paulo 03340-000 BR
Other 510(k) Applications for this Company
Contact
Denise Domiciano
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
11/07/2019
Decision Date
05/14/2020
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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