FDA
CustMbite, Model Number CBT-SRS-UL
The device was marketed and sold in the US without FDA clearance.
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.