Dental Choice Holding Llc Recall 90639
Description: CustMbite, Model Number CBT-SRS-UL
Dental Choice Holding Llc Recall 90639 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1494-2022 |
| Event ID | 90639 |
| Event Description | CustMbite, Model Number CBT-SRS-UL |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 708 |
| Recall Reason | The device was marketed and sold in the US without FDA clearance. |
| Device Classification | 20220810 |
| Device Code Info | UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222 |
| Center Classification Date | 20220802 |
| Recall Initiation Date | 20220523 |
| Recalling Firm | Dental Choice Holding Llc |
| Initial Notification | Letter |
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