ClearanceBrief
Company ยท US

Brius Technologies Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2021. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
DYJRetainer, Screw Expansion, Orthodontic3
NXCAligner, Sequential1
PNNOrthodontic Software1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 1, 2021K212828BRIUS Planner Software
Brius Technologies, Inc.
PNN
Jan 22, 2021K202792BRIUS Clear Aligners
Brius Technologies, Inc.
NXC

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 7, 2022Brius Technologies Inc.
Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Terminated
DYJNone listed
Feb 7, 2022Brius Technologies Inc.
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Terminated
DYJNone listed
Feb 7, 2022Brius Technologies Inc.
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Terminated
DYJNone listed
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