Jeltrate® Dustless Alginate Impression Material 605224Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI D0026052241), received between Jun 13, 2025 and Sep 3, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22952477 ↗
• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22952025 ↗
• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22951903 ↗
• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22951881 ↗
• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22951869 ↗
• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22951852 ↗
• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22951825 ↗
• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22951743 ↗
• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22951722 ↗
• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE AVA GEL REFILL 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22951579 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS. ONE OF THE STUDENTS HAD TO SEEK MEDICAL ATTENTION DUE TO THE SEVERITY OF THE REACTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22202349 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22202303 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22202281 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22202235 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22202229 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22202216 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22202199 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22202165 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT STUDENTS FROM A SCHOOL OF DENTISTRY CLAIM TO HAVE HAD AN ALLERGIC REACTION TO THE JELTRATE REG DUSTLESS 410 GR. REPORTEDLY, THEIR SYMPTOMS INCLUDED SMALL BLISTERS IN THE MOUTH, CHEEK AND BURNING AFTER BEING USED IN A PRACTICAL PROCEDURE IN CLASS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22202149 ↗