3M Unitek Corporation

FDA Regulatory Profile

3M Unitek Corporation appears in FDA public data with 1 recall, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0797-2025, Class II) was initiated on November 26, 2024. Its most recent 510(k) clearance was granted on January 27, 2017.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0797-2025Class II3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) TNovember 26, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K1636893M Clear Tray AlignerJanuary 27, 2017
K113197APC FLASH-FREE ADHESIVEFebruary 2, 2012
K102803CLARITY ADVANCED CERAMIC BRACKETSFebruary 17, 2011