1. Product Identification
1.1. TECHNICAL NAME
Protective resin of brackets
1.2. PRODUCT TRADE NAME
YPROTECT
1.3. DESCRIPTION OF THE PHYSICAL PRINCIPLE AND FUNDAMENTALS OF PRODUCT TECHNOLOGY, APPLIED TO ITS OPERATION AND ACTION
YPROTECT is an easy-to-apply light-curing material that aims to prevent injuries to the oral soft tissues caused by fixed orthodontic appliance devices, such as brackets, bands and wire ends. YPROTECT can be used on prominent parts of orthodontic devices promoting a rounded barrier on them, avoiding contact of these surfaces with the mucosa and future local abrasions, perforations, and ulcerations.
1.4. SPECIFICATIONS AND TECHNICAL CHARACTERISTICS
| COMPONENTS |
|---|
| Methacrylate monomers |
| Acid monomers |
| Inorganic load |
| Pigments |
| Primers |
| Stabilizers |
2. Storage
YPROTECT should be packaged at 2 to 28°C. The YPROTECT product should be used at room temperature (23ºC) and should not be exposed to heat and sunlight, or other direct light sources.
3. Instructions for use
3.1. APPLICATION TECHNIQUES
– Identify areas that may cause discomfort to the patient; – Keep the area isolated and dry; – Adapt the applicator tip and apply the YPROTECT resin on the sharp or cutting areas previously identified. Try to dispense the product, forming a rounded barrier with size capable of avoiding contact of the device with the mucosa. Use disposable spatula or micro applicators if necessary to accommodate the resin; – Avoid contact with the dental structure and points that interfere with the mechanics of the orthodontic treatment; – Light cure for 20 seconds. Use photopolymerizer with minimum power of 400mW/cm² of irradiance. – Check if there is no occlusal interference and wear with sandpaper disc if necessary; – Check the efficiency of the product, questioning the patient. If necessary, dry the place and reapply the YPROTECT product.
4. Precautions, restrictions, warnings
4.1 PRECAUTIONS
– YPROTECT should be used by professionals; – Keep the product out of the reach of children
4.2. RESTRICTIONS AND WARNINGS
– Eyes: may cause moderate irritation; – Skin: may cause moderate irritation; – Ingestion: may cause gastric irritation; – Inhalation: may cause irritation of the upper respiratory tract; – Allergy: the product is contraindicated for people allergic to the components of the formula; – Avoid direct contact of YPROTECT with the skin and eyes. In case of contact, remove the material immediately and wash thoroughly with soap and water.
5. Indication
– YPROTECT is indicated for covering the surface of orthodontic devices, such as brackets, bands and wire ends of fixed appliances to prevent lesions in the oral mucosa, such as abrasions, perforations, and local ulcerations.
6. Validity
See packaging for expiration dates.
Yller Biomaterials SA is not responsible for damages, of any nature, caused by incorrect use or use not foreseen in the instructions of use.
MANUFACTURED AND DISTRIBUTED BY:
Yller Biomateriais SA Address: 3852 São Francisco de Paula Ave., Areal Neighbourhood, Pelotas/RS, 96080-730 | Tel.: (53) 3027 3933 | www.yller.com.br/ | sac@yller.com.br CNPJ:16.970.346/0001-52 Technical responsible: Aline de Oliveira Ogliari CRO/RS No. 19623 ANVISA [National Health Surveillance Agency] Registration No.: 81009350017 REV:01
