510(k) K222211

Implant Direct Dental Implant Systems Portfolio - MR Conditional by Implant Direct Sybron Manufacturing, LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2023
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