SA3, LLC

FDA Regulatory Profile

SA3, LLC appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0856-2022, Class II) was initiated on February 21, 2022. Its most recent 510(k) clearance was granted on October 23, 2025.

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