Xsmart XSMARTCARecalls & reported problems
Tulsa Dental Products LLC · X-Smart Contra Angle 16:1 · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D716XSMARTCA1), received between Nov 6, 2023 and Nov 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2023Mechanical Problem; Mechanical Problem
IN THIS EVENT IT IS REPORTED THAT X-SMART W/CONTRA ANGLE EUR STOPPED DURING TREATMENT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18073810 ↗
Other Handpiece, direct drive, ac-powered devices
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- Aseptico AEU-25Aseptico, Inc. · Handpiece, Direct Drive, Ac-Powered6 reports
- Osstell SmartPeg Type 101Osstell AB · Handpiece, Direct Drive, Ac-Powered1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.