FDA Device recall Z-1494-2022
CustMbite, Model Number CBT-SRS-UL
- FDA Device
- Class II
- ongoing
- Published 2022-08-10
On 2022-08-10 the FDA classified a Class II recall of CustMbite, Model Number CBT-SRS-UL by Dental Choice Holding, citing the device was marketed and sold in the US without FDA clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1494-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-23 |
| Published | 2022-08-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Dental Choice Holding |
| Distribution | US |
Product
CustMbite, Model Number CBT-SRS-UL
Reason
The device was marketed and sold in the US without FDA clearance.
Identifiers
| code_info | UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1494-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.