CustMbite, Model Number CBT-SRS-UL (Dental Choice Holding Llc) – the device was marketed and sold in t... (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CustMbite, Model Number CBT-SRS-UL
Brand
Dental Choice Holding Llc
Lot Codes / Batch Numbers
UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222
Products Sold
UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222
Dental Choice Holding Llc is recalling CustMbite, Model Number CBT-SRS-UL due to The device was marketed and sold in the US without FDA clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device was marketed and sold in the US without FDA clearance.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026