MANUFACTURER  Progressive Orthodontics USA  135 Columbia Suite # 101 Aliso Viejo, CA 92656 USA Tel +1 714 973 2266 Fax +1 714 973 0145 Email Brenda@posortho.net www.posortho.com

Instructions for Use- Elastics & Elastomerics 

Disclaimer:  We the Manufacturer declare under our sole responsibility that the following methods of use and intended purpose are the methods recommended and approved for all of our orthodontic elastics and elastomeric products. It is the users responsibility to ensure the proper use, cleanliness and following of these instructions. Progressive Orthodontics USA makes no other representations or warranties regarding its orthodontic elastics and elastomeric products, either expressed or implied. In addition, in no event will Progressive Orthodontics USA be liable for any incidental, special or exemplary damages or loss of profits in connection with the use of our orthodontic elastics and elastomeric products.

These Instructions for Use do not replace the training and care by the user and risks that result from incorrect use. Any serious incident occurring in relation to our products must be reported back to us and the competent authority of the Member State in which the user and / or patient is established immediately.

Device Name: 

Dental and Orthodontic elastics and elastomeric products (single use) 

Intended Use: 

Devices are designed and manufactured for use for treatment of patients with orthodontic disorders by dental professionals who are qualified to provide orthodontic treatment and who understand how to use the devices properly. These devices are not intended to be implanted; their intended use is in the mouth only; they should contact but not penetrate mucous membranes in the mouth; These devices (elastics and elastomerics) are used with fixed orthodontic braces (dental brackets glued to teeth that are used with archwires, springs, wires, or other orthodontic accessories and appliances). Unique device configurations are customized for each patient and are selected by the orthodontist to apply forces to teeth to reposition them in the jaw to improve tooth alignment and create a healthy bite. A healthy bite is obtained when teeth in one jaw are aligned to properly meet teeth in the other jaw and thus can provide the patient with cosmetic benefits that result from improved alignment and leveling of the teeth. In addition, better oral hygiene and dental health, more efficient chewing and swallowing, improved digestion, prevention of jaw problems, and better speech and breathing can be benefits of appropriate orthodontic treatment.

Figure 1. Orthodontic devices shown in patients mouth during treatment. 

1. Top left: colorful elastomeric ligatures (arrow A) attached to archwire (arrow B) and brackets (arrow C) glued to teeth; 
2. Top right: rubber band (2 arrows) attached to archwire hooks are replaced by patient daily; 
3. Bottom left: gray elastomeric chain (arrow) connecting brackets glued to teeth; 
4. Bottom right: blue elastomeric separators used between teeth showing insertion sequence from left separator to right final placement (arrow).

Contraindication: 

Our Instruments should not be used for anything other than their intended use. Circumstances listed below may reduce the chances of a successful outcome:

1. Compromised vascularity. 
2. Previous history of infections, periodontal disease, patients with poor oral hygiene or caries of infections. 
3. Ulcers in the mouth. 
4. Mental, physical or neurological conditions, which may impair the patient’s ability to cooperate with the treatment. 
5. Patients suffering from systemic diseases such as hyperthyroidism, diabetes, tuberculosis, and psychosis are generally not suitable for orthodontic treatment, and those with severe malnutrition and pregnant women. 
6. Patients having known allergies to polymers, Latex or dyes in the devices. 
7. Patients with existing bone or root resorption, existing decalcification of dental enamel or existing periodontal complications.

Cautions: 

	Warnings Our labels and Instructions for Use (IFU’s) have been designed using symbols recognized by ISO 15223-1: 2021
	Read all Instructions for Use before using the device for the 1st time
	Non sterile and are not intended to be used in a sterile state. Sterilization can compromise product safety and performance and is not recommended. CAUTION: Federal law restricts these devices to sale and use by professional orthodontists and dental professionals
	Single-use only; the devices lose their effectiveness with use and cannot be sterilized to prevent microbial transmission without losing function, so reuse is not intended.
	Product shelf life (under proper storage conditions) is 3 years from manufacture date. The manufacture date can be determined from the lot number. The Use-by date is printed as Year-Month-Day (YYYY-MM-DD) or Year-Month (YYYY-MM).
	Store between 6 °C and 25 °C.
	Store products in a dry place to maintain cleanliness.
	Store products away from direct sunlight or strong light which shortens shelf-life.
	Packaged in plastic bags made of polyethylene plastic film with zippers made of ethylene-vinyl acetate copolymer. If packaging is breached upon receipt, the patient or orthodontic professional must not use the product and should provide lot number and product information to Progressive Orthodontics USA for investigation of the issue.

General Warnings and Precautions for use:

During orthodontic treatment there is a low risk of harm to patients of: 

1. Treatment relapse. 
2. Allergic reactions to the devices (especially to latex). 
3. Swallowing or aspiration of the devices. 
4. Discoloration or decalcification of teeth. 
5. Bone and root resorption, periodontal complications.
6. Infection related to device issues. 
7. Difficulties in maintaining oral hygiene. 
8. Oral and mucosal damage. 
9. Difficulty in speaking or chewing, discomfort, and pain. 
10. Breakage or loss of device function with use of oral hygiene products, whitening toothpastes, or certain foods.

Instructions for use 

The use of Orthodontic elastics is restricted to dental professionals with qualification in orthodontics. Use by persons outside this context may result in irreversible damage to the patient. The type of elastic to be used is made by the qualified professional, based on their knowledge acquired during their training in conjunction with the diagnosis and treatment plan for each patient. 

1. Select the elastic band to be used based on desired force. Consider any known latex allergy. Consider latex allergy when selecting the appropriate elastic band. 
2. Connect the elastic to the appropriate points of the orthodontic appliance to create a force vector as required. 
3. Patient should be monitored regularly when undergoing orthodontic treatment. Any serious incident experienced with the use of the product should be reported to the manufacture and the competent authority.

Disposal 

The professional should use good clinical practices for the disposal of medical products in accordance with current sanitary regulations. 

Patient Instructions 

1. Elastic rubber bands should be replaced according to the instructions provided by the dental professional. 
2. Patient compliance and full understanding of proper band placement is required for successful outcome. 
3. Practice good oral hygiene to prevent plaque installation and subsequent periodontal disease. Follow orthodontist recommendations for proper at home care. 
4. Care should be taken to avoid habits or foods that could break or dislodge the elastic band. In the event of breakage, reapply a new elastic band according to the orthodontist instructions.

Note: This is a controlled document & must be checked to the Master Documents List for latest revision level   TCF-EE-IFU    Rev: 0