INSTRUCTIONS FOR USE (IFU) - UK CUSTOM-MADE DEVICE (CMD - Custom Made Device)
Device Family: Teeth Whitening Tray
GMDN: 63350
Product Code(s): THERMOBT
Manufacturer:
Zima International, Inc. Also DBA Dandy
1320 N. 300 W.
Lehi, UT 84043
United States
Contact:
UK Responsible Person (UKRP):
Name = DANDY LABS GB, LTD
Company Number = 16873608
Registered Address = 5 New Street Square, London EC4A 3TW.
Intended User: Prescriber Dental professional / dental practice
Device Type: Custom-made dental device (CMD)
Sterility: Not supplied sterile (if applicable)
Single-use / Reusable: Reusable
1) Intended Purpose (Intended Use)
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.
2) Device Description / Key Specifications
- Custom-made, patient-specific device manufactured per dental professional prescription and digital input data.
- Configuration: Bleaching trays are dental devices that aid in lightening natural tooth enamel. They are either designed with or without wells to help contain bleaching material.
- Material: Erkodent
3) Contraindications
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.
4) Warnings / Precautions / Potential Risks
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
5) Cleaning and Care (Patient Care Instructions — as directed by the dental professional)
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.
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.
6) Storage
The device should be stored in a dry, clean container when not in use.
7) Expected Life / Service
Bleaching trays can last for many years, even a decade or more, with proper care, as their life depends on physical durability and preventing tooth movement; while the trays last, the whitening results typically need touch-ups every 6-12 months, depending on lifestyle, but the gel itself loses potency after about a year.
8) Incident / Complaint Reporting (UK)
Report suspected serious incidents associated with this device to:
- The Manufacturer and/or UK Responsible Person (UKRP) using the contacts above, and
- The UK Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with local requirements.
9) 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.
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.