Endosealer Plus Root Canal Sealant Instructions

Endosealer Plus Root Canal Sealant

DESCRIPTION

Endosealer Plus is a root canal sealer with an epoxy-amine resin outstanding physical system with chemical properties. system in It features homogenization auto-mixing tips, making it possible to apply it directly into the root canal, saving time and material. It has excellent radiopacity, favouring observation of the clinical field in radiographic images.

PRESENTATION
1 Double-body syringe with 15 g and 10 application tips.

INDICATION
Endosealer Plus is a product intended for the permanent filling of root canals, in combination with gutta-percha cones. in

COMPOSITION

Amber paste: fillers, amines, radiopacifiers, solvents and stabilizers. White paste: fillers, ероху resin, radiopacifiers, solvents and stabilizers.

MODE OF USE

The syringe and tips cannot be reprocessed. In all procedures in which Endosealer Plus is used, the professional must wear protective gloves and goggles. Cavity preparation Before applying the material, the root canals must be prepared, properly cleaned and dried. In all these procedures, the techniques intrinsic to endodontics should be used.

Note 1: Note 1: Before hitting the auto-mixing tips, a little material should be dispensed onto a surface until the white and amber pastes flow in the same proportion. If the professional does not do this, the product not set properly and the clinical application may be compromised.
Note 2: When hydrogen peroxide is used as an irrigation solution, new irrigation with sodium hypochlorite and saline solution should be carried out, followed by complete drying, before Endosealer Plus is applied.

Root canal sealant

1. Remove the cap by pressing down and turning 90° at the same time.
2. To assemble the applicator tip, fit the auto-mixing tip and then the intracanal tip. The tIp has a single-position adaptation system so as not to mix the pastes inappropriately.
3. After attaching the material applicator tip, the available for clinical application.
4. Carefully press down on the syringe plunger and the two pastes will automatically homogenize in the cannula of the auto-mixing tip.
5. After application, replace the syringe cap and sanitize the system with 70% alcohol.
6. This product should be used with gutta-percha cones. Setting time Timing refers to the time from the start of the application (auto-mixing tip) to complete the hardening of the product. At temperatures up to 25 °C, the product sets within 60 hours. On the other hand, at body temperature (36 – 37 °C), the maximum reaction time is 24 hours after the start of application.

WARNINGS

• For dental surgeon use only.
• Do not reuse empty packaging.
• Keep the material out of the reach of children.
• This material has been manufactured for dental use only and must be handled in accordance with the instructions for use.
• The manufacturer is not responsible for damage caused by otherUSes or by incorrect handling not described in this manual. In addition, the user is obliged to check, prior to use and under their own compatibility, the compatible that this material is the intended use, especially when this use is not indicated in the present instructions for use.
• Strictly follow the procedures provided in the instructions for use.
• If asepsis is carried out with hydrogen peroxide or sodium hypochlorite, dry thearea thoroughly before applying the endodontic cement.
• Do not allow loose objects, pastes or fragments to be swallowed or aspirated.
• Contact of uncured Endosealer Plus with skin, mucous membranes and eyes should be avoided. When still uncured, the product may have a slightly irritating effect.
• In case of allergic reactions, discontinue use immediately. Seek medical advice if necessary.
• Single-use product. After the setting reaction, the product does not return to its initial consistency.
• Reprocessing forbidden.
• Do not expose the temperatures above 25 °C. material to
• Do not expose the material directly to sunlight.
• Replace the syringe cap immediately after use.
• Avoid contact with the eyes to avoid damaging the cornea. In the event of a reaction with this tissue, rinse with plenty of water and seek medical attention.
• Avoid contact with the oral mucosa to prevent the formation of inflammatory processes. In the event of accidental contact, rinse with plenty of water and seek medical attention.
• Avoid ingesting the product. In accidental cases, the patient should drink plenty of water and, in the event unwanted reactions, medical assistance should be requested.
• Endosealer Plus contains a reaction system of a chemical epoxy-amine resin. Allergic reactions have been described in the literature in some patients who have had contact with other materials with a similar chemical formula on the skin, eyes and oral mucosa. In these cases, the professional should advise patients and check their allergic predisposition.
• Do not apply too much Endosealer Plus in the cavity, so as periapical tissue. not to damage the
• Do not use the material if the packaging is damaged.

PRECAUTIONS

• This product should only be used under the instructions for use.
• Wear PPE when handling the product, including gloves and goggles. It is recommended that patients also wear goggles.
• Contact with canal fluids, blood and saliva can compromise the success of the restoration. In these cases, a suitable isolation system should be used.
• Contaminated syringes should be discarded.
• Syringes cannot be reprocessed and must be handled with disinfected gloves.
• A new application tip should be used for each patient to avoid contamination.
• The professional chooses to handle Endosealer Plus without the applicator tips, proper homogenization must be carried out to guarantee the complete setting of the material inside the root canal. In addition, the product should be handled on a sterile glass plate and should not be shared with other patients.
• Before fitting the application tips, a little material should be dispensed onto a surface until the white and amber pastes flow in the same proportion.  If the professional does not do this, the product may not set properly and the clinical application may be compromised.
• In the case of storage in refrigerated systems, the material should be left at room temperature before application so that it reaches the appropriate fluidity.

CONTRAINDICATION
Endosealer Plus should not be used in case of known hypersensitivity (allergy) to any of the components of the formula.

EFECTO ADVERSE
To date, no adverse effects of the Endosealer Plus product have been identified. However, there are reports in the literature of allergic reactions involving dental products with epoxy resins and amines. In these cases, the professional should advise the patient and discontinue use.

STORAGE CONDITIONS
Store Endosealer Plus in its original packaging in a clean, dry place. Keep the material properly sealed and away from light or high humidity. The product should be kept at a controlled temperature between 4 °C and 25 °C.

VALIDITY
If packaged according to the manufacturer’s instructions, the product has a shelf life of 24 months from the date of manufacture. Do not use after the expiration date.

DISPOSAL

• Do not reuse the product and dispose of per local legislation.

Symbology

Manufacturer:
CNPJ: 05.823.205/0001-90

Address:

• Av. Melvin Jones, 773
• Pq. Ind. Bandeirantes
• 87070-030 | Brasil
• Technical Resp.:
• CRF-PR: 14.038
• Reg. ANVISA N°: 80322409023

SAP

• Customer service
• 0800 726 5848
• sap@maquira.com.br

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