Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material 605700Recalls & reported problems
Dentsply International Inc. · Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set, Case of 12 pouches · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI D0026057001), received between Dec 1, 2023 and Dec 1, 2023 — classified as 7 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility7
Patient problems
- Hypersensitivity/Allergic reaction7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED ALLERGIC REACTION TO STUDENTS REPORTEDLY OCCURRED USING JELT CHROMA F/S 454GM PCH/JELTRATE CHROMA DUSTLESS ALGINATE - FOR USE BY THE STUDENTS DURING THIS ACADEMIC YEAR. THE STUDENTS EXPERIENCED ADVERSE REACTIONS INCLUDING ULCERS, BLISTERS, AND MUCOSITIS AFTER USING THE PRODUCT. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18245784 ↗InjuryDec 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED ALLERGIC REACTION TO STUDENTS REPORTEDLY OCCURRED USING JELT CHROMA F/S 454GM PCH/JELTRATE CHROMA DUSTLESS ALGINATE - FOR USE BY THE STUDENTS DURING THIS ACADEMIC YEAR. THE STUDENTS EXPERIENCED ADVERSE REACTIONS INCLUDING ULCERS, BLISTERS, AND MUCOSITIS AFTER USING THE PRODUCT. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18245718 ↗InjuryDec 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED ALLERGIC REACTION TO STUDENTS REPORTEDLY OCCURRED USING JELT CHROMA F/S 454GM PCH/JELTRATE CHROMA DUSTLESS ALGINATE - FOR USE BY THE STUDENTS DURING THIS ACADEMIC YEAR. THE STUDENTS EXPERIENCED ADVERSE REACTIONS INCLUDING ULCERS, BLISTERS, AND MUCOSITIS AFTER USING THE PRODUCT. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18245678 ↗InjuryDec 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED ALLERGIC REACTION TO STUDENTS REPORTEDLY OCCURRED USING JELT CHROMA F/S 454GM PCH/JELTRATE CHROMA DUSTLESS ALGINATE - FOR USE BY THE STUDENTS DURING THIS ACADEMIC YEAR. THE STUDENTS EXPERIENCED ADVERSE REACTIONS INCLUDING ULCERS, BLISTERS, AND MUCOSITIS AFTER USING THE PRODUCT. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18245586 ↗InjuryDec 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED ALLERGIC REACTION TO STUDENTS REPORTEDLY OCCURRED USING JELT CHROMA F/S 454GM PCH/JELTRATE CHROMA DUSTLESS ALGINATE - FOR USE BY THE STUDENTS DURING THIS ACADEMIC YEAR. THE STUDENTS EXPERIENCED ADVERSE REACTIONS INCLUDING ULCERS, BLISTERS, AND MUCOSITIS AFTER USING THE PRODUCT. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18245384 ↗InjuryDec 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED ALLERGIC REACTION TO STUDENTS REPORTEDLY OCCURRED USING JELT CHROMA F/S 454GM PCH/JELTRATE CHROMA DUSTLESS ALGINATE - FOR USE BY THE STUDENTS DURING THIS ACADEMIC YEAR. THE STUDENTS EXPERIENCED ADVERSE REACTIONS INCLUDING ULCERS, BLISTERS, AND MUCOSITIS AFTER USING THE PRODUCT. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18245345 ↗InjuryDec 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED ALLERGIC REACTION TO STUDENTS REPORTEDLY OCCURRED USING JELT CHROMA F/S 454GM PCH/JELTRATE CHROMA DUSTLESS ALGINATE - FOR USE BY THE STUDENTS DURING THIS ACADEMIC YEAR. THE STUDENTS EXPERIENCED ADVERSE REACTIONS INCLUDING ULCERS, BLISTERS, AND MUCOSITIS AFTER USING THE PRODUCT. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18245300 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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