Recall Z-1494-2022 ยท LRK Device, Anti-Snoring
Dental Choice Holding Llc
CustMbite, Model Number CBT-SRS-UL
| Date | May 23, 2022 |
| Status | Open, Classified |
| Reason | The device was marketed and sold in the US without FDA clearance. |
| 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 customerservice@custmbite.com. |
| Quantity | 708 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.