Device product
Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Z-0890-2022
Product summary
- Event
- Event 89569
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13
- Official record key
device-enforcement:Z-0890-2022
Official wording
Reason: Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Code information: 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
Distribution pattern: US Nationwide: CA, DC, MA, NJ, NY, TX
Derived failure modes
-
Unknown
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.