FDA recall Z-1494-2022
Dental Choice Holding Llc · Class II · device
Product
CustMbite, Model Number CBT-SRS-UL
Reason for recall
The device was marketed and sold in the US without FDA clearance.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2022-05-23
- Report date
- 2022-08-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Louisville, KY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1494-2022