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Open, Classified

CustMbite, Model Number CBT-SRS-UL

FDA Recall Z-1494-2022 · Posted None

Recalling FirmDental Choice Holding Llc
Recall StatusOpen, Classified
Product CodeLRK
Date Initiated2022-05-23
Product Quantity708

Reason for Recall

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

Firm 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].

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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