Young Dental 296906Recalls & reported problems
Young Dental Manufacturing I, LLC · ClearDefense Silver Fluoride Hypersensitivity Varnish · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00302730003307), received between Jan 6, 2026 and Jan 6, 2026 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD SWELLING UNDER THE LEFT EYE AND CHEEK 30 MINUTES AFTER BEING TREATED WITH CLEAR DEFENSE PRODUCT IN UPPER LEFT QUADRANT OF MOUTH OF ONE .05ML DROP ACROSS THREE MAXILLARY TEETH FOR TREATING "HYPERSENSITIIVTY." 4% ARTICAINE 1:100,000 EPI LOWER LEFT QUADRANT ALSO USED AT DENTAL VISIT. PATIENT WENT TO URGENT CARE AND WAS DIAGNOSED WITH AN ALLERGIC REACTION AND WAS SUCCESSFULLY TREATED WITH BENADRYL.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 23974321 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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