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NexTemp 3001470Recalls & reported problems

Premier Dental Products Company · NexTemp Bulk Pack Opaque · Class 2

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 00348783000207), received between Apr 12, 2023 and Apr 12, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Improper Chemical Reaction” (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.

Most reported problems

Device problems

  • Improper Chemical Reaction1

Patient problems

  • Burning Sensation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 12, 2023Improper Chemical Reaction; Improper Chemical Reaction

    DENTIST APPLIED NEXTEMP CEMENT TO HIS GLOVED HAND SINCE PATIENTS HAVE BEEN MORE SENSITIVE TO TEMPERATURES RECENTLY. HE REPORTED THAT NEXTEMP GOT EXTREMELY HOT AND HAD TO RIP HIS GLOVE OFF DUE TO PAIN FROM THE HEAT. DENTIST ASSUMES THAT NEXTEMP MAY BE TOO HOT ON PATIENTS TOOTH PREPARATION BASED ON THE ADVERSE EVENT WHICH OCCURED ON HIS GLOVED HAND.

    Patient problems: Burning Sensation

    MAUDE report 16727422 ↗

Other Cement, Dental devices

All Cement, Dental devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.