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CELEBRACE Instructions For Use

Please Read All Instructions Carefully

Device Description:
Celebrace consists of a set of custom-designed metal orthodontic devices intended for precise tooth movement.

Indication for Use:
Celebrace is intended for use as an orthodontic appliance, applying gentle force to tooth surfaces to gradually move teeth according to a predefined treatment plan.

Caution:

  • Rx only. Federal law restricts this device to sale by or on the order of a physician.
  • This product may contain nickel, titanium, copper, chromium, molybdenum, zirconium, tin, gold, platinum, silver, iridium, zinc, palladium, and nitride. It should not be used by individuals with known allergies to these materials. Discontinue use immediately if hypersensitivity occurs.
  • The Celebrace system is customized for each individual patient and is not reusable. It should only be used by the patient for whom it was designed.
  • The Custom Bonding Tray (CBT) must be used to place the brackets on the teeth. Do not attempt manual placement.
  • Ensure the correct appliance is used for each jaw. The letter “U” indicates the upper jaw, and “L” indicates the lower jaw.


Contraindications:

  • Patients with poor oral hygiene
  • Patients with active periodontal disease


Precautions:

  • Celebrace devices are non-sterile.
  • Accidental swallowing of Celebrace components may be harmful.


Complications:

Celebrace can cause serious side effects, though they are rare. Monitoring by a doctor is essential. If Celebrace is removed, these side effects often subside. Potential side effects include:

  • Discomfort
  • Tissue damage
  • Relapse (tooth movement post-treatment)
  • Decalcification and dental caries
  • Root resorption
  • Nerve damage
  • Periodontal disease
  • Injury from orthodontic appliances
  • Temporomandibular joint dysfunction
  • Ankylosis
  • Occlusal adjustment
  • Non-ideal results
  • Allergic reaction
  • Complications due to third molars
  • Complications from tobacco use
  • Complications from temporary anchorage devices

Should any complications arise, a referral to your dentist or another dental/medical specialist may be necessary for further treatment.

Storage:

Store the Celebrace device at room temperature in its original packaging until ready for placement.

Recommended Procedure:

1. Prepare the teeth for bracket bonding:

    • Isolate, clean, rinse, and dry
    • Micro-etch
    • Rinse and dry
    • Apply etch
    • Rinse and dry
    • Apply bonding resin, dissipate, and light cure

2. Install the brackets using the provided CBT tray:

    • Apply composite
    • Clear excess with a microbrush
    • Firmly press CBT tray over dentition
    • Light cure for 3 seconds per tooth
    • Remove the tray
    • Cure each bracket an extra 5 seconds after removing the CBT

3. Engage Celebrace first AI wire into the brackets bonded with the CBT tray.

4. Advance to the next set of AI-designed wires as determined by the doctor’s decision.

The removal of wires and brackets can be performed using standard orthodontic industry techniques.

Oral Hygiene Instructions for Patients

Maintaining excellent oral hygiene is crucial during the Celebrace treatment. These instructions are recommended to ensure the best results:

1. Brushing:

    • Teeth should be brushed at least twice a day with fluoride toothpaste.
    • A soft-bristle toothbrush or an electric toothbrush should be used.
    • The brush should be angled at 45 degrees towards the gum line and teeth should be gently brushed in circular motions.
    • Special attention should be given when cleaning around the brackets and wires.

 

2. Flossing:

    • Teeth should be flossed daily using a floss threader or orthodontic floss to clean between teeth and under the wires.
    • The floss should be gently inserted between the teeth and moved up and down to remove plaque and food particles.

 

3. Interdental Brushes:

    • Interdental brushes should be used to clean between the brackets and under the wires where a toothbrush may not reach.

 

4. Mouthwash:

    • Mouth should be rinsed with an antibacterial mouthwash to reduce plaque and gingivitis.
    • A fluoride mouthwash should be considered to strengthen the teeth.

 

5. Avoid Certain Foods:

    • Hard, sticky, and chewy foods that can damage the brackets and wires should be avoided.
    • Fruits and vegetables should be cut into smaller pieces to prevent dislodging the appliance.

 

6. Regular Dental Checkups:

    • A dentist should be visited regularly for professional cleanings and checkups.
    • Dentists should be informed that patients are undergoing orthodontic treatment with Celebrace.

 

By following these oral hygiene instructions, patients can help achieve a successful treatment outcome with Celebrace.