Chrysalis Intelligence · Sponsors · Brius Technologies, Inc.

Brius Technologies, Inc.

Carrollton, TX, US · 2 510(k) clearances · 3 recalls

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Total clearances

2

2021-01-22 → 2021-10-01

Last 12 months

0

Product codes

2

Most recent

2021-10-01

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
PNN	Orthodontic Software	Class II	Dental	1	2021-10-01
NXC	Aligner, Sequential	Class II	Dental	1	2021-01-22

Safety

Recalls (3)

Class I (serious)

0

Risk of injury / death

Total recalls

3

Currently ongoing

0

Most recent

2022-02-07

Date	Severity	Status	Recall #	Product	Code	Reason
2022-02-07	Class II	Terminated	Z-0890-2022	Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 5…	—	Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, an…
2022-02-07	Class II	Terminated	Z-0889-2022	Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile,…	—	Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, an…
2022-02-07	Class II	Terminated	Z-0888-2022	Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device…	—	Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, an…

Filings

All 510(k) clearances (2)

Date	K-number	Device	Code	Class	Specialty
2021-10-01	K212828	BRIUS Planner Software	PNN	Class II	Dental
2021-01-22	K202792	BRIUS Clear Aligners	NXC	Class II	Dental