Henry Schein 5703853Recalls & reported problems
Henry Schein, Inc. · Maxima Advanced 3000 LED Curing Light · Class 2
Data updated Oct 13, 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 00304040186008), received between Jan 16, 2026 and Jan 16, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Excessive Heating” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Excessive Heating1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2026Excessive Heating
THE CURING LIGHT GETS TOO HOT AND BURNED A PATIENT DURING A PROCEDURE.
Patient problems: Burn(s)
MAUDE report 24097131 ↗
Other ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION devices
- SmartLite® Pro Modular LED Curing Light 644400Dentsply International Inc. · ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION7 reports
- Elipar™ DeepCure-S 769763M Deutschland GmbH · ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION1 report
- VALO 5972Ultradent Products, Inc. · ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION1 report
- SPEC 3 60013941Coltene/Whaledent Inc · Activator, Ultraviolet, For Polymerization1 report
- Essentials 5701741Henry Schein, Inc. · ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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