Dental Choice Holding Llc recalls CustMbite, Model Number CBT-SRS-UL
- Recall date
- May 23, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1494-2022
- FDA classification
- Class II
- Brand / firm
- Dental Choice Holding Llc
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
The device was marketed and sold in the US without FDA clearance.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CustMbite, Model Number CBT-SRS-UL
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