Dental Choice Holding Llc: Medical Device Recall in 2022 - (Recall #: Z-1494-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CustMbite, Model Number CBT-SRS-UL

Product Classification:

Class II

Date Initiated: May 23, 2022

Date Posted: August 10, 2022

Recall Number: Z-1494-2022

Event ID: 90639

Reason for Recall:

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

Status: Ongoing

Product Quantity: 708

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated