FDA-Device2022-04-13Class II
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Brius Technologies Inc.
Hazard
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Sold states
US Nationwide: CA, DC, MA, NJ, NY, TX
Affected count
6
Manufactured in
2611 Westgrove Dr, Carrollton, TX, United States
Products
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0888-2022Don't want to check this manually?
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