510(k) K203072

Franz Zirconia Dental Crown by Franz Biotech, Inc. — Product Code ELL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2022
Date Received
October 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Porcelain
Device Class
Class II
Regulation Number
872.3920
Review Panel
DE
Submission Type