Aevizol Ridge Cross-Linked Hydrogel

Package contents: 2 gel syringes of 0.5 ml each + 2 cross-linking syringes of 0.5 ml each + 8 needles

Aevizol® Ridge Preservation It is a biocompatible hydrogel scaffold with a three-dimensional structure, easily positioned and shaped within the bone defect. Its matrix promotes the recellularization of the defect. The elastic and flexible characteristics that emulate the activity of the native extracellular matrix (ECM) (provides a physical scaffold to cells and structural support to tissues, offering specific signals necessary for regeneration and homeostasis) combined with the chemical and biological activity, allow Aevizol® Ridge to correctly form the clot and maintain its stability.

Aevizol® Ridge increases cell vitality thanks to its ability to retain soluble dentin molecules within itself, improving their regeneration capacity.

It is indicated for the maintenance of alveolar bone volume.

Regenerative therapy in dentistry has gained interest, given the complexity of restoring dental and periodontal tissues with inert materials. The best approach to regeneration requires three elements to restore the functions of affected or diseased organ tissues: cells, bioactive molecules, and scaffolds. This triad is capable of modulating the processes to replace lost or damaged tissues and restore function, as it impacts various cellular processes, positively influencing cellular behavior to induce complete restoration of function and morphology of such complex tissues.

Aevizol® Ridge It has demonstrated advantages as a scaffold because it is a soft, elastic, hydrophilic three-dimensional (3D) network that allows for cell encapsulation and recruitment. It induces changes in cellular processes such as chemotaxis, proliferation, angiogenesis, and biomineralization, improving the regeneration process.

Aevizol® Ridge It has an anti-inflammatory effect.

Ministerial Authorization No. 2503951

UDI-DI 18057729070011

Instructions

Mechanism of action

Aevizol® Ridge It is a hydrogel with good adhesion that, after application, undergoes solidification to perform various functions:

1. Filling the desired site, preventing the infiltration of food residues.
2. It performs a mechanical action to preserve the vertical volume at the application site.
3. It seals the application site, through muco-adhesive action, to hinder bacterial spread.

Aevizol® Ridge It is indicated in all cases where the preservation of vertical volume is required.

Product Information

Aevizol® Ridge It is a ready-to-use medical device for topical application. It should be stored in the dark and at a moderately cool room temperature, preferably between 15°C and 25°C.

Advantages

The product consists of two components: the first is a transparent, viscous gel to be applied to the affected area; the second, also transparent and highly fluid, contains the hardening solution capable of inducing gel solidification. The resulting compound acquires a firmer consistency, and the sealing prevents its reduction.

Contraindications

No contraindications have been found with the use of Aevizol® Ridge. Use is not recommended in cases of known hypersensitivity to the product components. Known individual hypersensitivity to the product. The product must not be administered to individuals sensitive to egg proteins. In pregnant women, the product should only be administered when absolutely necessary.

Composition

It contains water (98%) and highly biocompatible polymers.

Aevizol® Ridge is composed of hydrogel and a hardening solution.

Syringe assembly

Unscrew the luer lock cap of the pre-filled syringe and insert the corresponding sterile needle.

How to Use

Aevizol® Ridge is an easy-to-use product for topical application.

Prepare the area of interest.

1. Screw on the corresponding blunt needle and deposit the contents of the syringe with Hydrogel into the area to be treated.
2. Bring the cross-linking saline solution into contact with the product to induce its transformation into a compact form.

A few drops are sufficient. Close the flaps.

Aevizol® Ridge promotes clot formation and stabilizes it.

A single application is sufficient.

Precautions

Aevizol® Ridge It is not intended for uses other than those indicated. Do not apply in cases of known hypersensitivity.

Warnings

To hold / To keep / To maintain Aevizol® Ridge Keep out of reach of children. Do not use if the packaging is damaged. Do not use after the expiry date on the packaging. The expiry date refers to the product in its original, undamaged packaging. Once opened, Aevizol® Ridge It must be used immediately and any residue disposed of. The device is for single use only. Do not dispose of in the environment after use. The application of Aevizol® Ridge It must be performed by the dentist, who will discontinue its use in case of an established individual sensitivity to the product's components.

Package contents

The package contains four plastic syringes with Luer-lock fittings (two containing 0.5ml of gel and two containing cross-linking aqueous solution), sterile blunt needles, and instructions.

Storage Methods

Store in a closed container, away from light and heat, at room temperature (15-25°C). Do not freeze or refrigerate.