FDA-Device2022-08-10Class II
CustMbite, Model Number CBT-SRS-UL
Dental Choice Holding Llc
Hazard
The device was marketed and sold in the US without FDA clearance.
Sold states
US Nationwide distribution.
Affected count
708
Manufactured in
10100 Linn Station Rd, N/A, Louisville, KY, United States
Products
CustMbite, Model Number CBT-SRS-UL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1494-2022Don't want to check this manually?
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