CustMbite, Model Number CBT-SRS-UL

Company

Dental Choice Holding Llc

Recall Initiated

May 23, 2022

Recall Number

Z-1494-2022

Quantity

708

Firm Location

Louisville, KY

Reason for Recall

The device was marketed and sold in the US without FDA clearance.

Distribution

US Nationwide distribution.

Lot / Code Info

UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222

Root Cause

No Marketing Application

Action Taken

Firm began notifying customers via recall letters on 5/23/22 and 6/6/22. A second round of letters was sent on 6/30/22 non-responding customers. Customers are instructed to cease use of the product and to discard it immediately. The firm will provide a full refund to affected customers. To receive a full refund of the purchase price, please contact Dental Choice Holdings Customer Service between the hours of 9am and 5pm Eastern Standard Time at 1-(855)-253-4680 or send an email to customerservice@custmbite.com.