FDA-Device2022-04-13Class II
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
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
4
Manufactured in
2611 Westgrove Dr, Carrollton, TX, United States
Products
Brius Patient Specific Brackets (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-0889-2022Don't want to check this manually?
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