Bleaching Tray IFU

The device is made of biocompatible materials and is custom-made for each patient. Bleaching trays are plastic retainers made using models of your teeth that hold whitening (bleach) gel.  Each tray is custom-made to fit over the user’s upper and lower teeth “like a glove.”  To perform treatments, the user places whitening gel in the trays and then seats them over their teeth according to the whitening gel manufacturer’s instructions.

Indications for Use

Bleaching trays are dental devices that aid in lightening natural tooth enamel.  They either be designed with or without wells to help contain bleaching material.

Contraindication

Patients with sensitivity, root exposure, active caries, or heavily restored teeth.  Teeth should be evaluated first, to see if the patient is a candidate for bleaching.

Potential Risks and Benefits of Bleaching Trays

Advise patients of the following:

The benefits of using bleaching trays are the potential to lighten tooth enamel.  Almost anyone can benefit. However, teeth whitening treatments may not be as effective for some individuals as they are for others.  Crowns, veneers, and existing dental fillings will not whiten so those with these in the “smile line” will likely have uneven results.  Teeth with multiple colorations, bands, splotches, or spots due to tetracycline use or fluorosis do not whiten as well. The potential risks include sensitivity and/or chemical burns to soft tissue, which should resolve after a few days. Using a sensitivity toothpaste or prescription-strength fluoride before and after treatment will help eliminate this sensitivity

Directions for Use

To ensure proper use of bleaching trays, dental professionals and patients should follow these steps:

• Brush and floss your teeth thoroughly before wearing your bleaching trays.  Toothpaste without additional whitening agents (called sensitivity toothpaste) will cause less sensitivity to your teeth during your whitening experience. 
• Whitening Gel (tooth bleach) should be placed in your bleaching trays using a small dot (pea-sized ) or a thin ribbon in each tooth area, excluding the molars.
• Depending on which bleaching product is used.  Either use twice a day for 15 minutes at least 3 days or nights in a row, or 45 minutes once a day for about a week.  Do not eat or drink when wearing the trays.
• Should any whitening gel squeeze out of the tray onto the soft tissue, this should be wiped off as it may cause irritation.  Should a large amount squeeze out of the trays make sure to use less next time.
• By the third day of whitening, your patient’s teeth may be slightly sensitive.  Taking ibuprofen will help with discomfort. 
• It is normal to experience stripping or streaking on the teeth.  The color should even out a few days after use.
• Avoid smoking, coffee, red wines, and other staining food and drink while whitening and for 3 days after.  Failing to do so could allow for unfavorable results.
• After using bleaching trays, rinse them thoroughly with water and allow them to dry before placing them in your case.
• Follow the manufacturer’s directions for the product you use.

Adjustment recommendations

• Sharp scissors are helpful if the trays are overextended for your preference or too jagged for you.
  • Just trim away any unwanted areas of the bleaching trays.

Cleaning instructions **

To clean the bleaching trays, patients should follow these steps:

Dandy recommends cleaning your device daily before and after every use. Immediately after (or soon after) removal, use warm water (not to exceed 45°C/113°F) and dishwashing soap to remove remaining saliva and bleaching gel from the device.

• Only use soft, antibacterial dish soap (liquid)
• Do not use flavored or scented soaps
• Do not use soaps with heavy dyes and colors
• Rinse the device thoroughly with cool water.
• Do not use hot water, as it can warp the device.
• Do not use mouthwash, as it can discolor the device.
• Clean the device daily.

**Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: June 2024 

USING CLEANING AGENTS

For periodic debris removal and maintenance, use a soft-bristle brush to clean the inside of your appliance. 

Do not use:

Avoid immersing the product in, or cleaning it with, any of the following substances: sodium hypochlorite (chlorine bleach), hydrogen peroxide, mouthwash, or alcohol products. Using these can lead to discoloration and damage to the material.

Storage instructions

The device should be stored in a dry, clean container when not in use.

Additional Information

• Patients should consult their healthcare provider if they experience a chemical burn.
• Patients may experience mouth or tooth sensitivity when first using the device, which typically resolves within a few days.
• Bleaching trays typically come with a limited warranty, which may vary depending on the manufacturer.

Disposal

• Used bleaching trays should be disposed of in regular trash after being cleaned of residual gel.
• Steps
  • Clean the Trays: 
    • Before disposal, ensure the trays are clean. 
    • Rinse them with water and a mild dish soap to remove any remaining whitening gel or saliva. 
    • Avoid using abrasive toothpaste, as it can scratch the plastic.
  • Regular Trash: 
    • In most cases, once they are clean, the trays can be placed in regular garbage. 
    • They are generally considered single-use disposables in a dental setting.
  • Avoid Curbside Recycling:
    • Most municipal curbside recycling programs do not accept small, rigid plastic items like flower pots, plastic cutlery, or specific dental trays due to their size and mixed materials. 
    • Placing them in the general recycling bin may contaminate the recycling stream. 
• Disposal of Leftover Bleach Gel
  • Dilute and Drain: 
    • Small amounts of diluted whitening gel can typically be poured down a sink or toilet drain.
  • Local Hazardous Waste: 
    • For large quantities of gel or if local regulations specify, contact your municipal waste collection company or health department to find a facility that accepts household hazardous waste.  
  • Always prioritize using up the product if possible, or giving away unused product to a friend or family member if it is not expired. 

ADA Codes

Material Safety Data Sheets (MSDS)

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

• Bleaching Tray

Laboratory Supplied IFUs: 

• Here