Brius Technologies Inc.

FDA Regulatory Profile

Brius Technologies Inc. appears in FDA public data with 3 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0888-2022, Class II) was initiated on February 7, 2022. Its most recent 510(k) clearance was granted on October 1, 2021.

Summary

Total Recalls
3
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0888-2022Class IIBrius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-SterileFebruary 7, 2022
Z-0889-2022Class IIBrius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RFebruary 7, 2022
Z-0890-2022Class IICustomized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, CustomFebruary 7, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K212828BRIUS Planner SoftwareOctober 1, 2021
K202792BRIUS Clear AlignersJanuary 22, 2021