Z-1494-2022Class II

CustMbite, Model Number CBT-SRS-UL

Name: Z-1494-2022 CustMbite, Model Number CBT-SRS-UL
Creator: Dental Choice Holding Llc
Published: 2022-05-23
License: https://open.fda.gov/license/

Dental Choice Holdings LLC / initiated 2022-05-23 / Open, Classified

FDA source

Dental Choice Holding Llc began a recall of CustMbite, Model Number CBT-SRS-UL on 2022-05-23. FDA classified it as Class II and gives the reason as "The device was marketed and sold in the US without FDA clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1494-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-23
Posted: 2022-08-02
Recalling firm: Dental Choice Holdings LLC
Product: CustMbite, Model Number CBT-SRS-UL
Product code: LRK Device, Anti-Snoring
Reason for recall: The device was marketed and sold in the US without FDA clearance.
FDA root cause: No Marketing Application
Action: 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 [email protected].
Quantity in commerce: 708
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1494-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1494-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-08-02

Product code LRK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)