1. Product Identification
GINGIMAX is an addition silicone used for gingival reproduction in laboratory models. GINGIMAX is presented in 3 versions:
– GINGIMAX ESTHETIC: translucency, vascularization, resilience and color similar to gum, allowing a high aesthetic;
– GINGIMAX HARD: high rigidity with Shore A-70 hardness, allowing easy cutting and wear;
– GINGIMAX CAD: Allows the manufacture of scannable artificial gingiva for CAD/CAM applications.
In all versions, a bottle of ISOLATOR with sprayer comes with the product.
2. Storage
In all versions, a bottle of ISOLATOR with sprayer comes with the product.
3. Instructions for use
– Ensure that the mold to be worked on is properly disinfected and free of moisture;
– Spray the Isolator insulator in the region where the gingiva will be reproduced. Wait until the insulation is completely dry;
– Spray the Isolator insulator in the region where the gingiva will be reproduced. Wait until the insulation is completely dry;
– Fit the GINGIMAX cartridge into a universal dispensing gun;
– Remove the lid and on the first use, trigger the gun, discarding a small amount of product in order to equalize the pastes. This procedure will only be necessary for the first use;
– Remove the lid and on the first use, trigger the gun, discarding a small amount of product in order to equalize the pastes. This procedure will only be necessary for the first use;
– Apply the product slowly and continuously on all contours, without interruption and without lifting the tip, so as not to incorporate bubbles into the material;
– Total working time for all versions is around 1 minute (23°C) and final setting after 10 minutes (23°C);
– Make the model in a conventional way.
– Make the model in a conventional way.
Additional notes
GINGIMAX is an addition silicone with high dimensional stability, which can be used for a long time after preparation. Internal studies guarantee its dimensional stability for up to at least 21 days after application.
The use of Isolator is extremely important to avoid adhesion or contamination of the product with the other elastomeric materials used in the molding. If the molding is carried out with alginate, the use of the insulator is not necessary.
GINGIMAX ESTHETIC, GINGIMAX HARD and ISOLATOR are products exempt from ANVISA registration.
4. Precautions, restrictions and warnings
4.1 PRECAUTIONS
– The polymerization of addition silicones is inhibited by latex gloves. Use talc-free vinyl or nitrile gloves. – GINGIMAX should only be used by professionals. – Keep the product out of the reach of children.
5. Validity
See manufacturing and expiry dates on the packaging.
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:
Manufacture and expiration dates see packaging. Yller Biomaterials SA is not responsible for damages of any nature caused by incorrect use or use not provided for in the instructions for use. MANUFACTURED AND DISTRIBUTED BY: Yller Biomaterials SA Address: Av. São Francisco de Paula, 3852, Bairro Areal, Pelotas / RS, 96080-730 Phone: (53) 3027 3933 / www.yller.com.br / sac@yller.com.br CNPJ: 16.970.346/0001-52 Technical manager: Aline de Oliveira Ogliari CRO/RS No. 19623 REV:03

