AH PLUS ROOTCANAL 667003Recalls & reported problems

Dentsply De Trey GmbH · AH Plus Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B. With its supporting accessory (Mixing Pad) it can be classified as a convenience kit. · 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 D0106670031), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

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

Most reported problems

Device problems

Patient-Device Incompatibility1

Patient problems

Pain1
Swelling/ Edema1

Recent adverse event reports

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

InjuryDec 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT AH PLUS EXPORT 3ML CHINA USED IN ROOT CANAL TREATMENT FOR PULPITIS, THE DOCTOR TRIED THE ROOT CANAL FILLING MATERIAL AND THE PATIENT COMPLAINED OF CONTINUOUS SWELLING AND PAIN IN THE AFFECTED TOOTH. DOCTOR REPLACE THE ROOT CANAL DISINFECTANT THAT MEET THE STANDARD CONCENTRATION FOR ROOT CANAL SEALING. IMMEDIATE SYMPTOMS AFTER INTERVENTION: MILD RELIEF OF SWELLING AND PAIN SYMPTOMS AFTER INTERVENTION.
Patient problems: Pain; Swelling/ Edema
MAUDE report 23719551 ↗

Device details

UDI-DI	`D0106670031`
Brand	AH PLUS ROOTCANAL
Model	667003
Company	Dentsply De Trey GmbH
Product code	KIF · RESIN, ROOT CANAL FILLING
Class	Class 2
FDA submission	None listed
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	Apr 2, 2018

Device type (GMDN): Endodontic filling/sealing material

A prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include (but are not limited to) silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). It does not include gutta-percha. After application, this device cannot be reused.

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All RESIN, ROOT CANAL FILLING devices →

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