FDAFDA · Food and drugs·Recall number Z-1494-2022
CustMbite, Model Number CBT-SRS-UL
Published August 10, 2022 · Recall initiated: May 23, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device was marketed and sold in the US without FDA clearance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dental Choice Holding Llc
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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