NexTemp 3001471Recalls & reported problems

Premier Dental Products Company · NexTemp Standard 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 00348783000214), received between May 21, 2025 and May 21, 2025 — classified as 1 injury.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Burning Sensation1
Hemorrhage/Blood Loss/Bleeding1
Skin Inflammation/ Irritation1

Recent adverse event reports

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

InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DENTIST AND HIS TEAM USED NEXTEMP ON THE PATIENT FOR TWO WEEKS. THE PATIENT'S TISSUE APPEARED RED, IRRIATED, AND BLEEDING WHEN THE PATIENT RETURNED TO THE OFFICE.
Patient problems: Burning Sensation; Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation
MAUDE report 22060816 ↗

Device details

UDI-DI	`00348783000214`
Brand	NexTemp
Model	3001471
Company	Premier Dental Products Company
Product code	EMA · Cement, Dental
Class	Class 2
FDA submission	K051866
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 15, 2022

Device type (GMDN): Dental composite resin

A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

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