TMD Appliance IFU

Dandy TMJ Appliances are intended to reduce pain and discomfort in the TMJ and sometimes help re-train muscles to avoid these movements. The devices are worn while sleeping to support patients’ TMJ  in the position prescribed by the dentists. The appliances are removable by the patient. 

Appliance Fit & Adjustments 

The dental staff or dentist should remove the appliance from its packaging and rinse it under water. Then, place the device in the patient’s mouth, checking for the proper fit and function of the appliance. The prescribing dentist should always perform the appliance adjustments. Any adjustments in the fit of the device should easily be made chairside to ensure that the patient is pleased with the fit and function of their new appliance.

Operating Instructions 

CLEANING 

Brush with a toothbrush before each use. 

STORAGE 

Dry and store in the provided case when not in use. 

FIT ADJUSTMENT 

The prescribing dentist or physician should make all adjustments

REMOVAL INSTRUCTIONS 

To remove the appliance properly, use both index fingers to pull down the front area of the upper appliance. 

For Dawson B-splint, do this for the upper first; second, for the lower, pull up in the front area.

To avoid breakage, do not pull down the back of the appliance.

FIT ADJUSTMENT 

Expect a 2-3 year product life with the appliance.

Appliance replacement signs are cracks in the acrylic and failure of the device to maintain retention in the patient’s mouth. 

Contraindications 

For the select subset of patients that have surgery to treat TMD or any TMJ issues, any further treatment with TMJ appliances or splints should be prescribed by the surgeon.

Warnings and Precautions 

WARNINGS 

Tooth movement or changes in dental occlusion 

Gingival or dental soreness 

Pain or soreness to the temporomandibular joint 

Obstruction of oral breathing 

Excessive salivation 

PRECAUTIONS 

Dentists should consider the medical history of their patients. Including history of arthritis, surgery, impact trauma, any previous TMJ treatment, respiratory disorders, or other relevant health problems, and refer the patient to the appropriate healthcare provider before prescribing the device.

ADA Codes:

Occlusal Guards
Night Guard - Occlusal Guard by Report D9940 Occlusal Guard by Report
Sports Guard - Fabrication of Athletic Mouthguard D9941 Fabrication of Athletic Mouthguard

Material Safety Data Sheets (MSDS)

Please see the attached night guard Material Safety Data Sheets for additional information.

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