Louisville, KY, United States
Dental Choice Holding Llc recalls
1 recall recorded since 2018, most recently on 23 May 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 May 2022
- Reason
- The device was marketed and sold in the US without FDA clearance.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1494-2022
- CustMbite, Model Number CBT-SRS-UL
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.