TI-MAX X CONTRA/HP X25LRecalls & reported problems
Nakanishi Inc. · Class 1
Data updated Oct 18, 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 04560264504608), received between Dec 23, 2025 and Dec 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Overheating of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device1
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.
InjuryDec 23, 2025Overheating of Device; Overheating of Device
ON JANUARY 29, 2026, NAKANISHI RECEIVED FURTHER INFORMATION ON THE EVENT FROM THE DENTIST. - THE EVENT OCCURRED ON NOVEMBER 26, 2025, NOT DECEMBER 10, 2025. - AT THE TIME OF THE EVENT, THE DENTIST WAS PERFORMING A POLISHING PROCEDURE AFTER PLACING THE ZIRCONIA INLAY ON THE PATIENT. - THE PATIENT WAS NOT UNDER ANESTHESIA. - DURING THE PROCEDURE, THE HEAD OF THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A WHITISH BURN INJURY TO THEIR BUCCAL MUCOSA, CORRESPONDING IN SIZE TO THE HEAD OF THE HANDPIECE. - THE PATIENT COMPLAINED OF MILD PAIN. - THE DENTIST WASHED THE PATIENT'S INJURY WITH SALINE AND APPLIED AN OINTMENT TO THE BURN OF THE PATIENT. - THE PATIENT IS REPORTED TO BE HEALED NORMALLY WITHOUT NEED FOR ANY FURTHER MEDICAL TREATMENT. - ACCORDING TO THE DENTIST, THERE WERE NO ABNORMALITIES OBSERVED IN THE DEVICE PRIOR TO USE.
Patient problems: Burn(s)
MAUDE report 23885720 ↗
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- Brasseler USA 5021285U0Peter Brasseler Holdings, LLC · Handpiece, contra- and right-angle attachment, dental3 reports
- Z99LNakanishi Inc. · Handpiece, contra- and right-angle attachment, dental3 reports
- TI-MAX Z CONTRA/HP Z95LNakanishi Inc. · Handpiece, contra- and right-angle attachment, dental3 reports
- Brasseler USA 5027608U0Peter Brasseler Holdings, LLC · Handpiece, contra- and right-angle attachment, dental2 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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