AutoMateRecalls & reported problems across all models
Dentsply International Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of AutoMate by Dentsply International Inc. in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2022 and May 29, 2026 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Break” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AutoMate problems
Device problems
- Break30
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information7
AutoMate models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AutoMate® 663016INSTRUMENTS, DENTAL HAND25 reports
- AutoMate® 663100INSTRUMENTS, DENTAL HAND5 reports
Recent AutoMate adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATE III BROKE DURING USE. ALL BROKEN PARTS WERE REMOVED FROM PATIENT'S MOUTH. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331329 ↗MalfunctionMay 18, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATE III BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25199584 ↗MalfunctionApr 17, 2026Break
IN THIS EVENT IT WAS REPORTED THAT A AUTOMATRIX EXTRA SHAFT ASSY BROKE DURING USE. BROKEN PARTS HAVE BEEN RETRIEVED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913377 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24859836 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24859064 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24858149 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24858069 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. ALL THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT'S MOUTH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858031 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. ALL THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT'S MOUTH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857665 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. BROKEN PARTS HAVE BEEN RETRIEVED FROM PATIENT'S MOUTH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857616 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24853943 ↗MalfunctionOct 30, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23422964 ↗MalfunctionJul 11, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A AUTOMATRIX TIGHTENING DEVICE BROKE DURING USE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478737 ↗MalfunctionJul 11, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A AUTOMATRIX TIGHTENING DEVICE BROKE DURING USE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478391 ↗MalfunctionMar 14, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT AN AUTOMATE III BROKE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604452 ↗
Other Dentsply International Inc. products
All Dentsply International Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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