510(k) K221488

Z7 Zirconia Implant System by Z7, LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2023
Date Received
May 23, 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