Essix A+ 10045Recalls & reported problems

Dentsply Sirona Orthodontics Inc. · Essix A+ Plastic .040 x 5" PETG Vacuum Square 100PK · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D746100451), received between Nov 13, 2024 and Nov 13, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Patient-Device Incompatibility1

Patient problems

Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

InjuryNov 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT, IT IS REPORTED, THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION FROM WEARING A NIGHTGUARD WITH ESSIX A+ PLASTIC, 040 X 5" PETG VACUUM SQUARE 100PK. REPORTEDLY, THEY NEEDED HOSPITAL CARE. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20673025 ↗

Device details

UDI-DI	`D746100451`
Brand	Essix A+
Model	10045
Company	Dentsply Sirona Orthodontics Inc.
Product code	KMY · POSITIONER, TOOTH, PREFORMED
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 30, 2023

Device type (GMDN): Dental appliance fabrication material, thermoplastic

A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

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