Instructions for Retainers

Device Description:

FXTetra Bright Retainers are custom made thermoplastic orthodontic retainers.

Indication for Use: FXTetra Bright Retainers are indicated for the prevention of a patient’s teeth from shifting position following orthodontic treatment.

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:

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

Precautions:

  1. Retainers are non-sterile, rinse before use.
  2. Accidental swallowing of retainers may be harmful.
  3. Keep your retainers away from children and pets
  4. Keep your retainers away from hot, acidic, sweet, or colored liquids.
  5. Keep your retainers out of excessive heat.
  6. Do not wear retainers while eating, drinking, chewing gum, or using tobacco products. Brush and floss your teeth after eating to prevent food from getting stuck in your teeth and under your OrthoFX retainers.
  7. Clean your retainers after brushing your teeth, by gently brushing your retainers using a toothbrush and rinsing with cool water.
 

Included Accessories: Retainer case, lip balm, whitening gel, removal tool, & promotional materials.

Recommended Procedure:

  1. Carefully remove the retainers and any additional accessories from the OrthoFX package and examine them for defects. Do not use defective equipment.
  2. Rinse the retainers thoroughly with cool water.
  3. Place the retainers on your teeth and push down. Please wear your retainers for 22 Hours per day for the first 6 months. Following the initial 6 months for at least 8 hours per day. Note: You may experience dry lips and/or mouth during retainer treatment, use the lip balm to keep your lips hydrated and drink water.
  4. The retainers will fit tightly and will apply pressure to your teeth. Note: You may notice a slight lisp when you initially start wearing your retainers. This typically goes away after a few days.
  5. Follow the instructions on your retainer package for guidance on when to change retainers.
  6. After treatment is complete, dispose in accordance with local government policy.
 

Storage:

  1. Store your retainers in the provided retainer case when not wearing them.

Warranty:

OrthoFX Retainers should be worn per the recommended procedure and may be used up to 3 to 6 months dependent on your care (excessive wear due to bruxism, loss, theft, damages, or manufacturing issues reported after 30 days of delivery will not be covered or replaced). In general, whenever your retainers look cracked, damaged or are showing signs of breakages, it’s time to switch to a fresh new set. You and your doctor can work together on purchasing a retainer subscription through our site so that you can maintain that beautiful new smile!

 

Complications:

FX Tetra Bright Retainers 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 you stop wearing the retainers. These side effects include:

  • Headgear injuries
  • Temporomandibular (Jaw) Joint Dysfunction
  • Impacted, Ankylosed, Unerupted Teeth
  • Occlusal Adjustment
  • Non-Ideal Results
  • Allergies
  • General Health Problems
  • Complications due to Third Molars
  • Complications due to the Use of Tobacco Products
  • Complications due to Temporary Anchorage Devices
  • 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
 

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.

Manufactured by:

OrthoFX

48890 Milmont Drive Suite 101D,

Fremont, CA 94538

www.orthofx.com

Instructions for Retainer Removal Tool

  • To remove your upper retainer, firmly grip the loop end with your fingers.
  • Place the hook end between your tooth and retainer (tongue side or cheek side) on your very last molar.
  • Gently pull downward with mild force to dislodge the retainer.
  • Repeat these steps for the lower retainer.

 

Warnings: for external use only. Keep out of reach of children and pets. Use only as instructed. Improper forceful use may result in gum discomfort or bodily harm. If this occurs, contact a health care professional. Use light & gradual increased pressure when removing your retainer. Forceful removal of retainers may cause retainer removal tool damage.