Unapproved CustMbite Medical Device Recalled Nationwide Due to Missing FDA Clearance
Dental Choice is recalling 708 units of the CustMbite Model CBT-SRS-UL device nationwide because it was marketed and sold without FDA clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: An unapproved medical device distributed nationwide qualifies as a risk-of-harm product. Although no illnesses or injuries have been reported, the unverified safety status of this Class II device justifies High severity classification.
Plain-English summary
Dental Choice Holding Llc is recalling 708 units of the CustMbite Model CBT-SRS-UL device. This medical device was distributed nationwide in the United States and was marketed and sold without FDA clearance.
FDA regulations require medical devices to obtain clearance before being marketed or sold to consumers. The CustMbite device did not receive this required FDA approval prior to being sold. Affected devices are identified by lot codes SS-J21287-200-1021, SS-K21333-510-1121, and SS-B22040-305-0222.
For more information regarding this recall, consumers can contact the FDA or Dental Choice Holding Llc. The recall was initiated due to the device's lack of required FDA clearance.
The recalled product
- Product
- CustMbite, Model Number CBT-SRS-UL
- Manufacturer
- Dental Choice Holding Llc
- Category
- Medical Device
- Hazard
- Affected units
- 708
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: N/a Lot codes: SS-J21287-200-1021
- SS-K21333-510-1121
- SS-B22040-305-0222
Distribution
Distributed nationwide across the United States.
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