Lynal® Tissue Conditioner and Temporary Reliner 653006Recalls & reported problems
Dentsply International Inc. · Lynal® Tissue Conditioner & Temporary Reliner Package · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 D0026530060), received between May 18, 2023 and May 18, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED DURING USE OF LYNAL PATIENT REPORTEDLY EXPERIENCED ALLERGIC REACTION OF BURNING SENSATION IN THEIR PALLET AFTER BEING APPLIED TO DENTURES. IT WAS APPROXIMATELY THREE HOURS AFTER BEING APPLIED. OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16952577 ↗InjuryMay 18, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED DURING USE OF LYNAL PATIENT REPORTEDLY EXPERIENCED ALLERGIC REACTION OF BURNING SENSATION IN THEIR PALLET AFTER BEING APPLIED TO DENTURES. IT WAS APPROXIMATELY THREE HOURS AFTER BEING APPLIED. OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16952551 ↗InjuryMay 18, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED DURING USE OF LYNAL PATIENT REPORTEDLY EXPERIENCED ALLERGIC REACTION OF BURNING SENSATION IN THEIR PALLET AFTER BEING APPLIED TO DENTURES. IT WAS APPROXIMATELY THREE HOURS AFTER BEING APPLIED. OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16952432 ↗
Other RESIN, DENTURE, RELINING, REPAIRING, REBASING devices
- TrueDent TrueDent YellowStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall13 reports
- TrueDent TrueDent ClearStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall4 reports
- TrueDent TrueDent MagentaStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall2 reports
- TrueDent TrueDent WhiteStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall0 reports
- TrueDent TrueDent CyanStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall0 reports
- COE-SOFT™ 344011Gc America Inc. · RESIN, DENTURE, RELINING, REPAIRING, REBASING2 reports
- Palapress Vario 64707889Kulzer GmbH · RESIN, DENTURE, RELINING, REPAIRING, REBASING1 report
- Mizzy Millennium 6010049Keystone Industries · RESIN, DENTURE, RELINING, REPAIRING, REBASING1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page