Recall Z-1494-2022— Dental Choice Holding Llc

Name: FDA recall Z-1494-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-23

Class II · Ongoing

Class II FDA medical device recall by Dental Choice Holding Llc, initiated 2022-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: CustMbite, Model Number CBT-SRS-UL. Reason: The device was marketed and sold in the US without FDA clearance..

Recalling firm: Dental Choice Holding Llc
Classification: Class II
Status: Ongoing
Initiated: 2022-05-23
Firm location: Louisville, KY, United States

Product description

CustMbite, Model Number CBT-SRS-UL

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.