Instructions for use
- Contains no BPA or phthalates
- Manufactured for:
OrthoFX – 48890 Milmont Drive,
Fremont, CA 94538
Device Description
OrthoFX Aligners are custom made thermoplastic orthodontic braces.
Indication for Use
OrthoFX Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
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
Warnings
- If you have an allergic reaction, please discontinue use and contact your doctor and OrthoFX Customer Service.
Precautions
1. Aligners are non-sterile, 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 white soap and rinsing with cool water.
Complications
Aligners can cause serious side effects; however, these side effects occur in only a small number of people. Your doctor will 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)
- Decalcification and Dental Caries
- Root Resorption
- Nerve Damage
- Periodontal Disease
- Temporomandibular (Jaw) Joint Dysfunction
- Occlusal Adjustment
- Non-Ideal Results
- Allergies
- General Health Problems
- Complications due to Third Molars
- Complications due to the Use of Tobacco Products
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 and print materials.
Recommended Procedure
- Carefully remove the OrthoFX aligners and any additional accessories from the OrthoFX package
and examine the them for defects. Do not use defective appliances. - Rinse the OrthoFX aligners thoroughly with cool water.
- Place the OrthoFX stage 01 aligners on your teeth and push down.
- Wear these stage 01 aligners for 22 hours a day for one week.
- OrthoFX aligners will fit tightly and will apply pressure to your teeth. This pressure will lessen over time as you wear your aligners
- Wear each stage of aligners for one week before advancing to the next stage of aligners, or as prescribed by your doctor.
- Your aligner packages are sequentially numbered for easy identification. Once you have worn the aligner stage for one week, move to your next aligner stage.
- Once you have moved onto the next aligner stage 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 cool water.
- After treatment is complete, dispose of aligners in accordance with local government policy.
Period of Use/Storage
- The aligner should be worn 22 hours per day.
- Do not wear aligner after expiration date printed on the bag it came in.
- Store your aligners in the provided OrthoFX aligner case when not wearing them.
These directions apply to OrthoFX Clear Aligners, Clear Aligners 2.0 and Bright Aligners.
