Dental Choice Holding LLC recalls CustMbite dental device (model CBT-SRS-UL) sold without FDA clearance. Affected units have specific lot codes. Consumers should contact the company for details.
The device was marketed and sold in the US without FDA clearance.
Dental Choice Holding LLC is recalling CustMbite dental devices (model CBT-SRS-:UL) because they were sold in the US without FDA approval. This means the product may not be safe for use as intended.
The device was marketed and sold in the US without FDA clearance, meaning it has not been tested for safety and effectiveness. This could lead to potential harm if used without proper regulatory oversight.
Dental patients who purchased CustMbite devices with lot codes SS-J21287-200-1021, SS-K21333-510-1121, or SS-B22040-305-0222 are affected. Patients using the device without FDA clearance may face safety risks.
Check for the model number CBT-SRS-UL on the device. Affected units have specific lot codes: SS-J21287-200-1021, SS-K21333-510-1121, or SS-B22040-305-0222.
Look for the lot code on the device: SS-J21287-200-1021, SS-K21333-510-1121, or SS-B22040-305-0222.
The device was marketed and sold in the US without FDA clearance, meaning it has not been tested for safety and effectiveness.
Check the lot code on your device. If it matches the affected codes, contact Dental Choice Holding LLC for instructions.
The recall record states the device was sold without FDA clearance, but does not specify injury risks or mechanisms.
We’ve drafted a message you can send Dental Choice to request your refund or repair — edit it as you like.
Subject: Recall Z-1494-2022 — Dental Choice Dental Choice Hello, I own a Dental Choice that is covered by recall Z-1494-2022 from Dental Choice. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
