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Published: 2022-04-13Captured: 2026-02-09Brius Technologies Inc.Product: Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
FDA issued a Class II enforcement action. Affects Brius Technologies Inc.. Reason: Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard desi.
- •Classification: Class II
- •Firm: Brius Technologies Inc.
- •Status: Terminated
- •Distribution: US Nationwide: CA, DC, MA, NJ, NY, TX
Reason
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Status:Terminated
Distribution:US Nationwide: CA, DC, MA, NJ, NY, TX
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