maQuira ENDOSEALER Root Canal Sealant User Guide
- June 12, 2024
- maquira
Table of Contents
SELANTE PARA CANAL RADICULAR
SELLADOR PARA CANAL RADICULAR
ROOT CANAL SEALANT
ENDOSEALER – Root canal sealant
PRESENTATION:
1 Bottle with 8 g of Endosealer powder and 1 tube with 9 g of Endosealer
resin.
DESCRIPTION:
Endosealer is a product designed for root canal obturation, with adequate
setting time and radiopacity for clinical application. Itis presented in
powder and resin form for easy handling.
INDICATION:
Endosealer is a product indicated for root canal obturation.
COMPOSITION:
Powder: Calcium hydroxide, amine and radiopacifiers. Resin: Epoxy resin.
MODE OF USE:
- The product must be manipulated in a glass plate or spatulation block. To do so, deposit an amount of powder intended for clinical work and add the amount of resin (resin) to the product. With a spatula, incorporate the powder into the resin. Homogenize until a smooth, yellowish mass is obtained;
- Add powder or resin until the consistency of the product is 1.5 to 2.5 cm above the glass plate when manipulated with the spatula. The product should form a thread when pulled in the opposite direction to the glass plate. The average ratio is approximately 3 parts powder to 1 part resin by volume;
- Dry the root canal to be worked. Endosealer cement should be introduced directly into the root canal with the aid of an endodontic instrument such as files, lentulo spiral or even the main gutta-percha cone;
- If you want to make the material flow more, gently heat the glass plate and bring the material into contact; 5. Clean the glass plate, spatula and other instruments immediately after use.
Note 1: When using hydrogen peroxide as an irrigation solution, reirrigation with sodium hypochlorite and saline solution, followed by complete drying, should be done prior to application of the Endosealer. Setting time: The setting time refers to the time from the beginning of application (mixing of powder + resin) to complete hardening of the product. At temperatures up to 25 °C the product sets in up to 60 hours. On the other hand, at body temperature, the maximum polymerization time is 24 hours after the start of application.
WARNINGS AND PRECAUTIONS:
- For dentist-surgeon use only;
- Do not reuse empty cartridge;
- Keep material out of reach of children;
- This material was manufactured for dental use only and must be handled according to the instructions for use. The manufacturer is not responsible for damage caused by other uses or by incorrect handling not described in this manual. Furthermore, the user is obliged to verify, prior to use and under is/her own responsibility, that this material is compatible with the intended use, especially when this use is not indicated in these directions for use;
- Endosealer should not be swallowed or aspirated. In the event of ingestion or aspiration, seek medical attention immediately;
- Strictly follow the procedures provided in the Directions for Use;
- In cases of more acute allergic reactions, discontinue use of the product;
- If asepsis with hydrogen peroxide or sodium hypochlorite is performed, dry the region efficiently before the application of the endodontic cement;
- The bismuth oxide in Endosealer may lead to a darkening of the tooth crown when used near the cervical region o on the dental crown. The dentist should avoid use in these areas and/or perform adequate isolation prior to procedures;
- Make sure that no residues of the product remain in the coronal pulp chamber, thus avoiding a possible negative influence on the tooth shade. The bismuth present in the formulation can irreversibly alter tooth shade. Avoid contact with enamel regions; Over long periods of time and depending on the storage method, the product may darken. This process does not compromise the application of the product;
- Wear PPE when handling the product, including gloves and goggles. It is recommended that patients also wear goggles;
- Do not allow objects, resin, powder, and loose polymerized parts to be swallowed or aspirated;
- Contact of unpolymerized endodontic cement with skin, mucous membranes and eyes should be avoided. When still unpolymerized, the product may have a mildly irritating effect;
- If the product comes into contact with the hands, wash with plenty of water; ein case of allergic reactions, continue use immediately. If necessary, seek medical advice; eSingle use product. After the polymerization the product does not return to its initial onsistency;
- Reprocessing forbidden;
- Do not expose the material to temperatures above 25 °C;
- Do not expose the material directly to sunlight;
- Replace the bottle and tube caps immediately after use.
CCONTRAINDICATIONS:
Endosealer should not be used in case of known hypersensitivity (allergy) to any of the components of the formula.
ADVERSE EFFECT:
To this date, no adverse effects of the product have been identified. However, there are reports in the literature of allergic reactions involving products with epoxy resins.
STORAGE:
- Store the product in its original container in a clean, dry place.
- Store the Endosealer properly sealed and without exposure to light or highity.
- The product should be kept at controlled temperature between 4 °C and 25°C.
VALIDITY:
If packaged as instructed by the manufacturer, the product has a shelf life of
24 months from the date of manufacture. Do not use after expiration date.
DISPOSA!
Do not reuse product and dispose of in accordance with local legislation.
Symbology
| Keep dry.
---|---
| Manufacturer.
| Consultinstructions for use.
| Batch code.
| Keep away from sunlight.
| Use – by date.
| Catalogue Number.
| Consultinstructions for use for important preventive information.
| Donot re-use.
| Temperature limit.
MADE IN BRAZIL.
maeuira. Otatal Group ri
Fabricante I Manufacturer:
Maquira Indtistria de Produtos Odontologicos S.A. CNPJ: 05.823.205/0001-90
Endereco I Direction I Address:
Av. Melvin Jones, 773 Pq. Ind. Bandeirantes Maringa – PR I 87070-030 I Brasil
Resp. Tecnico I Technical Resp.:
Cristiane Furlan I CRF-PR: 14.038 Reg. ANVISA N°: 80322409020
SAP:
Atendimento ao cliente Atencien al cliente Customer service 0800 726 5848
sap®maquira.com.br
0403143- rev. 00
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