SDI Limited

FDA Regulatory Profile

SDI Limited appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2954-2026, Class II) was initiated on July 20, 2026. Its most recent 510(k) clearance was granted on October 28, 2022.

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2954-2026Class IIDentsply Sirona Capsule Mixer Model No. 5546068July 20, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K222581Stela Automix SystemOctober 28, 2022
K222583Stela Capsule SystemOctober 28, 2022
K214118Riva Cem AutomixAugust 30, 2022
K191656ZipbondDecember 2, 2019
K172047Riva StarApril 11, 2018
K102984AURADecember 8, 2010