510(k) K240419

UltraThineer Zirconia Slurry (5Y-B) by Boston Micro Fabrication — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2024
Date Received
February 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type