Clear aligner instructions for use

  • Made in the USA
    Contains no BPA or phthalates
  • Manufactured by:
    OrthoFX – 48890 Milmont Drive,
    Fremont, CA 94538
  • Last Revised:
    12.3.2019
Best Clear Teeth Aligners - OrthoFX

Device Description

OrthoFX Invisible Clear Aligners are custom made thermoplastic polyurethane orthodontic braces.

Indication for Use

The OrthoFX Invisible Clear Aligners is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements, Smylio Invisible Clear Aligner sequentially positions teeth by way of continuous gentle force.

Caution

Rx only. Federal law restricts this device to sale by or on the order of a physician.

Contraindications

  1. Patients whose permanent teeth or second molars have not yet erupted
  2. Patients with poor oral hygiene
  3. Patients with active periodontal disease
  4. Patients with dental prosthetics or implants

Warnings

  1. If you have an allergic reaction, please discontinue use and contact your doctor and OrthoFX Customer Service

Precautions

  1. Aligners are non­sterile, rinse before use.
  2. Accidental swallowing of aligners may be harmful.
  3. Keep your aligners away from children and pets
  4. Keep your aligners away from hot, acidic, sweet or colored liquids.
  5. Keep your aligners out of excessive heat.
  6. Do not wear OrthoFX aligners while eating, drinking, chewing gum or using tobacco products. Brush and floss after eating to prevent food from getting stuck in teeth and under aligners.
  7. Clean your aligners after brushing your teeth, by gently brushing your aligners using a toothbrush and toothpaste and rinsing with warm water. Your OrthoFX aligners can also be cleaned by fully submerging them in Listerine for 15 minutes

Complications

OrthoFX Clear Aligners can cause serious side effects; however, these side effects occur in only a small number of people. Your doctor can monitor you for them. These side effects often go away if stop wearing the aligners. These side effects include:

  • Discomfort
  • Tissue damage
  • Relapse (tooth movement post treatment)
  • Extractions (tooth removal)
  • Orthognathic Surgery
  • Decalcification and Dental Caries
  • Root Resorption
  • Nerve Damage
  • Periodontal Disease
  • Injury from Orthodontic Appliances
  • Headgear injuries
  • Temporomandibular (Jaw) Joint Dysfunction
  • Impacted, Ankylosed, Unerupted Teeth
  • Occlusal Adjustment
  • Non­Ideal Results
  • Allergies
  • General Health Problems
  • Complications due to Third Molars
  • Complications due to the Use of Tobacco Products
  • Complications due to Temporary Anchorage Devices

 

If any of the complications mentioned above do occur, a referral may be necessary to your family dentist or another dental or medical specialist for further treatment.

Included Accessories

OrthoFX aligner case, lip balm, and emery board

Recommended Procedure

  1. Carefully remove the OrthoFX aligners and any additional accessories from the OrthoFX package and examine the them for defects. Do not use defective equipment.
  2. Rinse the OrthoFX aligners thoroughly with warm water
  3. Place the OrthoFX stage 1 aligners on your teeth and push down. Wear these stage 1 aligners for 8 hours a day for one week.
    Note: You may feel discomfort along the edge of the aligner. If you do, simply smooth the edge with the provided emery board. You may experience dry mouth during aligner treatment, drink water.
  4. OrthoFX aligners will fit tightly and will apply pressure to your teeth. This pressure will lessen over time as you wear your aligners\
    Note: You may notice a slight lisp when you initially start wearing your aligners. This typically goes away after a few days.
  5. After one week change to the stage 2 aligners. Place the OrthoFX clear aligners on your teeth and push down. Wear the OrthoFX clear aligners for 22 hours per day.
    Note: ONLY the stage 1 aligners may be worn only 8 hours a day, all other OrthoFX aligners should be worn 22 hours a day
  6. Follow the instructions on your OrthoFX aligner package for guidance on when to change to your new set of aligners. Your OrthoFX aligner package will clearly articulate when you should put your next set of OrthoFX aligners in.
  7. Your aligner packages are sequentially numbered for easy identification. Once you have worn the aligner for the recommended period of use, move to your next aligner.
  8. Once you have moved onto the next retainer in your treatment, keep your previously worn aligner in the package it came in, just in case you lose or break your current one. Before storing the aligner rinse thoroughly with warm water.
  9. After treatment is complete, dispose in accordance with local government policy.

Period of Use/Storage

  1. The aligner should be worn 22 hours per day
  2. The OrthoFX aligner package will clearly articulate when you should put your next set of OrthoFX aligners in. Do not wear aligners longer than instructed by the packaging
  3. Store your aligners in the case when not wearing them in the provided OrthoFX aligner case.