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Dental Choice Holding Llc Recall 90639

Description: CustMbite, Model Number CBT-SRS-UL

Dental Choice Holding Llc Recall 90639 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1494-2022
Event ID90639
Event DescriptionCustMbite, Model Number CBT-SRS-UL
Product TypeDevices
DistributionUS Nationwide distribution.
Recall ReasonThe device was marketed and sold in the US without FDA clearance.
Device Classification20220810
Device Code InfoUDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222
Center Classification Date20220802
Recall Initiation Date20220523
Recalling FirmDental Choice Holding Llc
Initial Notification Letter
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