# FDA recall Z-1494-2022

> **Dental Choice Holding Llc** · Class II · device recall initiated 2022-05-23.

## Product

CustMbite, Model Number CBT-SRS-UL

## Reason for recall

The device was marketed and sold in the US without FDA clearance.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1494-2022
- **Recalling firm:** Dental Choice Holding Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-23
- **Report date:** 2022-08-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, KY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1494-2022

## Citation

> AI Analytics. FDA recall Z-1494-2022. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-1494-2022. Source: US FDA. Licensed CC0.

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