Device product
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Z-0889-2022
Product summary
- Event
- Event 89569
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-0889-2022
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: 523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB
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.