SmartLite® Pro Modular LED Curing Light 644400Recalls & reported problems
Dentsply International Inc. · SmartLite® Pro Introductory Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI D0026444001), received between Aug 29, 2023 and Jan 4, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (7 reports).
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
- Overheating of Device7
Patient problems
- Discomfort6
- Inflammation6
- Pain6
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT SMARTLITE PRO INTRO KIT OVERHEATING AND CAUSING HOT SENSATION IN PATIENT'S MOUTH. REPORTEDLY, NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18444399 ↗MalfunctionAug 30, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT SMARTLITE PRO INTRO KIT SLP ON THE LED TIP GET EXTREMELY HOT AND THAT IT HAS CAUSED POSTOPERATIVE DISCOMFORT, PULPITIC DISCOMFORT AND THUS ENDO-TREATMENTS AS A RESULT AFTER INSERTING INLAYS. THE CUSTOMER REPORTEDLY, HEAT GENERATED WOULD CAUSE MASSIVE POSTOPERATIVE, PULPITIC COMPLAINTS AFTER INSERTION OF THE INLAYS AND HE WOULD HAVE SEVERAL ENDO TREATMENTS AS A RESULT.
Patient problems: Discomfort; Inflammation; Pain
MAUDE report 17651730 ↗MalfunctionAug 30, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT SMARTLITE PRO INTRO KIT SLP ON THE LED TIP GET EXTREMELY HOT AND THAT IT HAS CAUSED POSTOPERATIVE DISCOMFORT, PULPITIC DISCOMFORT AND THUS ENDO-TREATMENTS AS A RESULT AFTER INSERTING INLAYS. THE CUSTOMER REPORTEDLY, HEAT GENERATED WOULD CAUSE MASSIVE POSTOPERATIVE, PULPITIC COMPLAINTS AFTER INSERTION OF THE INLAYS AND HE WOULD HAVE SEVERAL ENDO TREATMENTS AS A RESULT.
Patient problems: Discomfort; Inflammation; Pain
MAUDE report 17651612 ↗MalfunctionAug 30, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT SMARTLITE PRO INTRO KIT SLP ON THE LED TIP GET EXTREMELY HOT AND THAT IT HAS CAUSED POSTOPERATIVE DISCOMFORT, PULPITIC DISCOMFORT AND THUS ENDO-TREATMENTS AS A RESULT AFTER INSERTING INLAYS. THE CUSTOMER REPORTEDLY, HEAT GENERATED WOULD CAUSE MASSIVE POSTOPERATIVE, PULPITIC COMPLAINTS AFTER INSERTION OF THE INLAYS AND HE WOULD HAVE SEVERAL ENDO TREATMENTS AS A RESULT.
Patient problems: Discomfort; Inflammation; Pain
MAUDE report 17651538 ↗MalfunctionAug 30, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT SMARTLITE PRO INTRO KIT SLP ON THE LED TIP GET EXTREMELY HOT AND THAT IT HAS CAUSED POSTOPERATIVE DISCOMFORT, PULPITIC DISCOMFORT AND THUS ENDO-TREATMENTS AS A RESULT AFTER INSERTING INLAYS. THE CUSTOMER REPORTEDLY, HEAT GENERATED WOULD CAUSE MASSIVE POSTOPERATIVE, PULPITIC COMPLAINTS AFTER INSERTION OF THE INLAYS AND HE WOULD HAVE SEVERAL ENDO TREATMENTS AS A RESULT.
Patient problems: Discomfort; Inflammation; Pain
MAUDE report 17651458 ↗MalfunctionAug 30, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT SMARTLITE PRO INTRO KIT SLP ON THE LED TIP GET EXTREMELY HOT AND THAT IT HAS CAUSED POSTOPERATIVE DISCOMFORT, PULPITIC DISCOMFORT AND THUS ENDO-TREATMENTS AS A RESULT AFTER INSERTING INLAYS. THE CUSTOMER REPORTEDLY, HEAT GENERATED WOULD CAUSE MASSIVE POSTOPERATIVE, PULPITIC COMPLAINTS AFTER INSERTION OF THE INLAYS AND HE WOULD HAVE SEVERAL ENDO TREATMENTS AS A RESULT.
Patient problems: Discomfort; Inflammation; Pain
MAUDE report 17651415 ↗MalfunctionAug 29, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT SMARTLITE PRO INTRO KIT SLP ON THE LED TIP GET EXTREMELY HOT AND THAT IT HAS CAUSED POSTOPERATIVE DISCOMFORT, PULPITIC DISCOMFORT AND THUS ENDO-TREATMENTS AS A RESULT AFTER INSERTING INLAYS. THE CUSTOMER REPORTEDLY, HEAT GENERATED WOULD CAUSE MASSIVE POSTOPERATIVE, PULPITIC COMPLAINTS AFTER INSERTION OF THE INLAYS AND HE WOULD HAVE SEVERAL ENDO TREATMENTS AS A RESULT.
Patient problems: Discomfort; Inflammation; Pain
MAUDE report 17640615 ↗
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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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