EDTA 15% GEL

Description

• Gel for chemical preparation of root canals
• Facilitate the introduction of instruments into a root canal thereby minimising the risk of their breaking.
• It cleans the canal removing mineral part of smear layer in order to expose dentine tubules prior to filling the canal.

Product destination:
THE MEDICAL DEVICE IS FOR DENTAL USE ONLY.
EDTA 15% gel is recommended for chemical preparation of root canals. It cleans the canal removing mineral part of smear layer in order to expose dentine tubules prior to filling the canal. The device contains disodium edetate which leaching magnesium and calcium ions makes the surface layer of dentine softer that can be easily removed and unblock the canal. The contained benzalkonium chloride reduces the surface tension which increases penetration of the device into the hard tissues of a tooth. The medical device in the form of a gel facilitate the introduction of instruments into a root canal thereby minimising the risk of their breaking.

Directions for use:
Before applying the product, fix a disposable needle to a syringe in a manner securing its separation. Then squeeze a small amount of gel to equalize the pressure in the syringe and ensure the proper flow of the product through the needle.
Apply EDTA 15% gel at the bottom of the tooth chamber or place the product directly on the canal tool, then mechanically prepare the canal. During mechanical preparation use sodium hypochlorite solution (HYPOCHLOR 2%) or disodium edetate (EDTA 15%) for rinsing the canal. After completing the canal preparation, thoroughly rinse the product from the canals and the tooth chamber with the sodium hypochlorite solution (HYPOCHLOR 2%).

Contraindications:
Do not use in patients with hypersensitivity on some of the ingredients. Do not use in pregnant women. Do not use after expiry date.

Precautions:
Do not use a powerful liquid jet during root canal rinsing because this may result that liquid can get to periapical tissues and irritate them which is manifested by pain and swelling of soft tissues.
It is important to pay attention during canal preparation next to anatomic hole because as a result of softening dentine there is a risk of root perforation by root canal tools.
Use cofferdam while handling the medical device. Causes serious eye and skin irritation. Wear protective gloves/protective clothing/eye protection/face protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Wash hands thoroughly after handling.
Do not use the device if any signs of damage are observed.
Expiry date does not change after opening under condition of tightly closing after each use.

Storage conditions:
Store in a dry place, in the original packaging tightly closed, at a temperature up to 25ºC. Protect from sunlight.

Transport conditions:
Do not exceed the temperature +40ºC during transport.

Expiry date:
Expiry date for use is printed on the immediate packaging.

Handling and storage of packaging:
Empty package recycle according to applicable provisions.

Composition:
Disodium edetate, sodium hydroxide, benzalkonium chloride, propylene glycol, hydroxyethyl cellulose, dye, purified water

Immediate packaging:
Syringe containing 5.5 g or 10 g of a product.