Medical device recalls Moderate risk

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

Get recall alerts

Free email alert whenever Dental Choice Holding Llc has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Dental Choice Holding Llc