Reported Aug 10, 2022 · Ongoing

CustMbite, Model Number CBT-SRS-UL

Dental Choice Holding LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dental Choice Holding Llc · 10100 Linn Station Rd · Louisville, KY · 40223-3861

Is this the product you have?

  • CustMbite, Model Number CBT-SRS-UL
Lot codes and dates
  • UDI-DIN/a
  • Lot codes
    • SS-J21287-200-1021
    • SS-K21333-510-1121
    • SS-B22040-305-0222
Amount recalled
708

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.