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Reline-It 1Recalls & reported problems

Majestic Drug CO. Inc. · The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00010705400968), received between Apr 7, 2017 and Apr 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Missing Value Reason” (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.

Most reported problems

Device problems

  • Missing Value Reason1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

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

  • MalfunctionApr 7, 2017Missing Value Reason; Missing Value Reason

    THE PRODUCT IS AN OTC DENTURE RELINER. THE EXACT AGE AND WEIGHT OF THE CUSTOMER IS NOT KNOWN. THE CUSTOMER HAS USED THE PRODUCT SEVERAL TIMES BEFORE AS INDICATED ON HIS E-MAIL COMMUNICATION. IN THIS INSTANCE THE CUSTOMER COMPLAINED OF A BURN ON THE ROOF OF HIS MOUTH AND RESULTING PAIN THE MORNING AFTER. AS A RESULT HE WAS NOT ABLE TO EAT FOR 2 DAYS OR WEAR HIS PARTIAL APPLIANCE. THE COMPANY REPLACED THE PRODUCT TO THE CUSTOMER ON (B)(6) 2016. THE CUSTOMER HAS NOT ADVISED THE COMPANY OF ANY FURTHER DISCOMFORT OR PAIN. NO MEDICAL INTERVENTION WAS REQUIRED.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 6471495 ↗

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