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U.S. Department of Health and Human Services

Class 2 Device Recall CustMbite

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  Class 2 Device Recall CustMbite see related information
Date Initiated by Firm May 23, 2022
Create Date August 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-1494-2022
Recall Event ID 90639
Product Classification Device, anti-snoring - Product Code LRK
Product CustMbite, Model Number CBT-SRS-UL
Code Information UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222
Recalling Firm/
Manufacturer		 Dental Choice Holding Llc
10100 Linn Station Rd
Louisville KY 40223-3861
For Additional Information Contact Dental Choice Holdings Customer Service
855-253-4680
Manufacturer Reason
for Recall		 The device was marketed and sold in the US without FDA clearance.
FDA Determined
Cause 2		 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 in Commerce 708
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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