SA3, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0856-2022Class IISilatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gmFebruary 21, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K252425Silatrix Oral GelOctober 23, 2025
K202000Silatrix Oral GelNovember 20, 2020