1. Product Identification
1.1. TECHNICAL NAME
Sealant for fossils and fissures with fluoride
1.2. PRODUCT TRADE NAME
YSEAL
1.3. DESCRIPTION OF THE PHYSICAL PRINCIPLE AND FUNDAMENTALS OF PRODUCT TECHNOLOGY, APPLIED TO ITS OPERATION AND ACTION
YSEAL is a light-curing resin sealant for pits and fissures of posterior teeth. YSEAL forms a continuous and resistant barrier that hinders the adhesion of plaque and food remains, aiming to prevent the development of dental caries in patients at high risk of caries and in newly erupted teeth.
1.4. SPECIFICATIONS AND TECHNICAL CHARACTERISTICS
1.4.1 Composition
| COMPONENTS |
|---|
| Methacrylate monomers |
| Ionometric Load |
| Fluorides |
| Silica Nanoparticles |
| Primers |
| Stabilizers |
| Pigments |
2. Storage
YSEAL must be conditioned at temperatures between 2 and 28ºC and in a dry place. The YSEAL 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
After cleaning the dental surface, including fossils and cracks, proceed with the following steps: – Make sure that the surfaces are free of caries; – Isolate the quadrant to be sealed with a rubber dam or cotton rollers and sucker, ensuring that the surfaces remain dry; – Apply the 37% phosphoric acid gel on the enamel for 30 seconds; – Remove the phosphoric acid gel with an air and water spray and dry with air jet until a matte and whitish surface is obtained; – Attach the applicator tip to the syringe and dispense the product directly on the occlusal surface. With the help of a brush or disposable micro applicator, spread the product to cover the areas of interest. Light cure for 20 seconds; – Remove the insulation and perform occlusal adjustment if necessary.
4. Precautions, restrictions, warnings
4.1 PRECAUTIONS
– The YSEAL patch 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 YSEAL with the skin and eyes. In case of contact, remove the material immediately and wash thoroughly with soap and water.
5. Indication
Sealing of fossils and fissures of deciduous and permanent teeth: – of patients at high risk of caries; – of newly erupted teeth; – of teeth with anatomy that is difficult to clean.
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.: 8100935011 REV:02
