510(k) K222231

S.I.N. Dental Implant System by S.I.N. - Sistema DE Implante Nacional S.A. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2022
Date Received
July 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type