CustMbite, Model Number CBT-SRS-UL
Reported: August 10, 2022 Initiated: May 23, 2022 #Z-1494-2022
Product Description
CustMbite, Model Number CBT-SRS-UL
Reason for Recall
The device was marketed and sold in the US without FDA clearance.
Details
- Recalling Firm
- Dental Choice Holding Llc
- Units Affected
- 708
- Distribution
- US Nationwide distribution.
- Location
- Louisville, KY
Frequently Asked Questions
What product was recalled? ▼
CustMbite, Model Number CBT-SRS-UL. Recalled by Dental Choice Holding Llc. Units affected: 708.
Why was this product recalled? ▼
The device was marketed and sold in the US without FDA clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2022. Severity: Moderate. Recall number: Z-1494-2022.
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