DSI DENTAL ApexSil RC Powder Liquid Instruction Manual

: June 16, 2024
: DSI DENTAL

Table of Contents

DESCRIPTION
COMPOSITION
PURPOSE
INDICATIONS
INSTRUCTIONS FOR USE
PRECAUTIONS
CONTRAINDICATIONS
STORAGE
PACKAGING
SYMBOLS
CUSTOMER SERVICES
References
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DSI DENTAL ApexSil RC Powder Liquid

DESCRIPTION

DSI ApexSil RC is a radiopaque, non-resorbable, Zinc Oxide-Eugenol based root canal sealer.
Its composition is well tolerated by the tissues and provides anti inflammatory action.

COMPOSITION

Powder: Zinc Oxide, Barium Sulphate, Accelerators, Preservative.
Liquid: Eugenol & Excipients.

PURPOSE

It is used as permanent root canal filling material.

INDICATIONS

Root canal filling and sealing in association with a gutta-percha point.

INSTRUCTIONS FOR USE

Mix carefully for approximately 45-60 sec, one scoop of powder and five drops of liquid to obtain a thick mix, which can easily be introduced into the canal with a suitable root canal filler, or in conjunction with a silver, acrylic, or gutta-percha point. Net setting time is 45-60 min from the start of the mix. The dispensed material shall not be placed back in the container and the dose once applied and used shall not be reused.
Warning: Avoid prolonged or repeated contact with skin (allergic contact dermatitis), and eyes. Avoid prolonged inhalation. Do not take it internally. Contact with the skin may cause irritation, burns, or hypersensitivity. If contact with skin occurs immediately wipe off thoroughly with cotton and alcohol and then wash well with soap and water. If skin rash and sensitization or other allergic reaction occurs discontinue use and seek medical attention. If the product comes into contact with the eyes, rinse thoroughly with fresh water and consult a physician. It should not be used with patients who have a history of severe allergic reactions to any of the components.

PRECAUTIONS

Do not use ApexSil RC with patients that have a history of allergic reaction to Iodine compounds. Avoids contact with eyes.

CONTRAINDICATIONS

Do not use in patients with a known allergy to any of its components.

STORAGE

Store at a temperature between 10°C (50°F) to 24°C (75°F). Close the cap carefully after use. Keep away from moisture. Shelf life is not affected after opening if stored in a cool dry place.
Shelf Life: 3 years from the date of Manufacturing.

PACKAGING

15g Powder, 10ml Liquid, Dispensing Dropper, Spoon and Mixing Pad.
Ref: ASIL-RC

SYMBOLS

| Consult instructions for use
---|---
| Caution, consult accompanying documents
| Temperature limit
| Keep away from sunlight
| Keep dry
| Non-sterile product
| Do not use if package is damage
| Keep Out of Reach of Children
| Medical Device
| Use by Prescription only
| Manufacturer
| Catalogue number
| Batch code
| Use by
| Date of Manufacture

Failure to comply with the conditions of storage leads to a change of the working characteristics of the material and decrease the shelf life of the material. The manufacturer is not responsible for any loss of quality caused by the failure to comply with terms of transportation, storage and use established by the manufacturer for this product. Responsibility for the use of the material for purposes other than those specified by the manufacturer falls on the user.