Brius Technologies Inc.: Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

Agency Publication Date: April 7, 2022

Affected Products

Product: Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

524947 .00BB (upper); 524925 .00BB (upper); 524503 .10Bn (upper); 523431 .20U; 524304 .10Bn (upper); 523595 .21bn (upper)

Product: Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB

Product: Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

523600 .40Bn Upper; 523738 .20BB Upper; 523927 .20Bn Upper; 524181 .01bl Lower; 524284 00U Upper; 524284 .01bn Upper; 524490 .02bn Upper; 524896 .00BB Upper; 525258 .00Bn Upper; 523431 .20U; 523431 .30U, 523431 .50U, 523431 .70U

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89569

Status: Resolved

Manufacturer: Brius Technologies Inc.

Manufactured In: United States

Units Affected: 3 products (6; 4; 13)

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Sources: FDA iRES · Raw API Response

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