AH PLUS JET 60620115Recalls & reported problems
Dentsply De Trey GmbH · AH Plus Jet Starter Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe (D010K3001600) delivery for homogeneous mixing of both pastes. With its supporting accessories (Mixing/Intraoral Tips, Mixing Pad and Organizer Tray) it can be classified as a convenience kit. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D010606201151), received between Jun 29, 2023 and Mar 4, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Too Soft/Flexible” (3 reports).
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
- Material Too Soft/Flexible3
- Loss of or Failure to Bond1
Patient problems
- Pain3
- Unspecified Infection2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
IN THIS EVENT IT IS REPORTED THAT AH PLUS JET STARTER KIT WAS USED IN TREATMENT OF 2 PATIENTS. REPORTEDLY, COMPLICATIONS AND POST OPERATIVE PAIN WAS REPORTED AFTER USE OF THIS PRODUCT. ONE PATIENT IS STILL TAKING MEDICATION DUE TO INFECTION. THE PHYSICIAN REPORTS THAT THE PROBLEM COULD BE WITH THE YELLOW PAST AND THE WHITE PASTE APPEARED IN THE MIXER AND THE CONSISTENCY WAS SOFT AND TAKING LONGER TO SET. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Pain; Unspecified Infection
MAUDE report 18825126 ↗InjuryMar 4, 2024Loss of or Failure to Bond; Material Too Soft/Flexible; Loss of or Failure to Bond; Material Too Soft/Flexible
IN THIS EVENT IT IS REPORTED THAT AH PLUS JET STARTER KIT WAS USED IN TREATMENT OF 2 PATIENTS. REPORTEDLY, COMPLICATIONS AND POST OPERATIVE PAIN WAS REPORTED AFTER USE OF THIS PRODUCT. ONE PATIENT IS STILL TAKING MEDICATION DUE TO INFECTION. THE PHYSICIAN REPORTS THAT THE PROBLEM COULD BE WITH THE YELLOW PAST AND THE WHITE PASTE APPEARED IN THE MIXER AND THE CONSISTENCY WAS SOFT AND TAKING LONGER TO SET. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Pain; Unspecified Infection
MAUDE report 18825035 ↗InjuryJun 29, 2023Material Too Soft/Flexible; Material Too Soft/Flexible
IN THIS EVENT IT IS REPORTED THAT AH PLUS JET STARTER KIT USED IN TREATMENT OF ROOT CANAL FILLING DOCTOR NOTICED THAT THE CONSISTENCY WAS TOO LIQUID AND HAD A ROTTEN EGG SMELL. AFTER TREATMENT THE PATIENT COMPLAINED OF PAIN. THE FILLING WAS REMOVED AND REPLACED; THE FILLING MATERIAL REMOVED WAS FOUND TO BE CRUMBLY ACCORDING TO THE DOCTOR.
Patient problems: Pain
MAUDE report 17224537 ↗
Other RESIN, ROOT CANAL FILLING devices
- AH Plus BioCermanic Sealer AHPBIOSEALTulsa Dental Products LLC · RESIN, ROOT CANAL FILLING46 reports
- AH Plus BioCermanic Sealer AHPBIOREFILLTulsa Dental Products LLC · RESIN, ROOT CANAL FILLING10 reports
- AH PLUS ROOTCANAL 60620110Dentsply De Trey GmbH · RESIN, ROOT CANAL FILLING4 reports
- BIOROOT RCS 01E0300Septodont Sas Specialites Septodont · Resin, Root Canal Filling2 reports
- AH PLUS JET 667005Dentsply De Trey GmbH · RESIN, ROOT CANAL FILLING1 report
- AH PLUS ROOTCANAL 667003Dentsply De Trey GmbH · RESIN, ROOT CANAL FILLING1 report
- RibbonTulsa Dental Products LLC · RESIN, ROOT CANAL FILLING1 report
- ProRoot MTA PROROOT5WTulsa Dental Products LLC · RESIN, ROOT CANAL FILLING1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.