maquira Light Curing Orthodontic Adhesive with Fluorescent User Manual
- June 12, 2024
- maquira
Table of Contents
FIX Light-curing orthodontic adhesive with
fluorescent tracker.
PRESENTATION:
1 syringe of FIX with 4 g,1 syringe of 37% Phosphoric Acid with 2,5 mL and 1 application tip.
DESCRIPTION:
FIX is a light cured orthodontic composite developed to provide the bonding of metallic, ceramic and polycarbonate orthodontic brackets onto the dental enamel surface during orthodontic treatment It is also suitable for cementing orthodontic accessories (such as bands) and tubes to the enamel surface. It contains a UV-fluorescent tracer that helps the professional to identify the presence of polymerized composite residues on the tooth surface after the removal of brackets at the end of the orthodontic treatment, allowing the selective removal of these contents from the tooth surface, avoiding any damage to the enamel caused by drills. The UV tracer is activated when the polymerized FIX is exposed to UV light FIX has excellent handling properties, holding the bracket in position and providing quick and easy cleaning of excess material from the tooth enamel surface prior to photoactivation. It provides extended working time for precise placement of the bracket. FIX combines polymer-based resin compound and bonding agent in a single syringe, allowing a 2-step clinical procedure: etching of the enamel surface with 37% phosphoric acid and bonding of orthodontic brackets on the tooth surface.
INDICATION OF USE:
FIX is a light cured orthodontic composited designed to promote bonding of metallic, ceramic and polycarbonate orthodontic brackets onto the enamel surface, during orthodontic treatment. FIX also contains a UV fluorescent tracker, which activates when receiving UV light (390-410 nm), allowing the adhesive to be visible after debonding of brackets.
COMPOSITION:
Monomers, photoinitiators, UV fluorescent agent, pigments and filler
particles.
HOW TO USE:
Bracket Bonding:
- Promote teeth prophylaxis with oil-free pastes. Wash with plenty of water.
- Perform efficient isolation of operatory field to keep it free from saliva contamination. Lip retractor (Flex Retractor or Expandex — Maquira) may be used for a better access to teeth. Dry teeth with air free of oil and moisture.
- Perform acid etching of enamel surface with 37% Phosphoric Acid (Maguire) for 15 to 30 seconds. Wash with plenty of water and drywith air free of oil and moisture.
- Apply small amount of FIX straight from the syringe onto the base of the bracket (metallic, ceramic or polycarbonate).
- Place the bracket at the desired position into the previously etched enamel. Compress it to release excess adhesive.
- Remove excess adhesive from enamel surface with the aid of an exploratory probe before photoactivation. Bracket must not be displaced from its correct position.
- Light cure the bracket’s margins for 80 seconds (20 seconds per margin) with light cure tip positioned as near as possible to the adhesive.
- Pumice prophylaxis is recommended after bonding the brackets.
- The orthodontic archwire can be placed immediately after bracket bonding.
Bracket DebondIng:
- At the end of the orthodontic treatment, remove the brackets with the aid of specific debonding plier. The residual adhesive should be removed with the aid of multilaminated drills and dine sandpaper discs. Care should be taken not to damage the enamel.
- In order to help the dentist selectively remove residual polymerized FIX bonded to dental enamel, UV tracker present into the adhesive may be activated by an ultraviolet light source (with intensity of 250 mW/cm2 and wavelength from 390 to 410 nm).
- Polish the teeth with felt disc and extra-fine frain polishing paste (Diamond Universal —Maquira).
WARNINGS AND PRECAUTIONS:
Product for professional use only. In case of allergy, discontinue use immediately and advise the patient to seek medical advice. Unpolymerized product may cause sensitization and should not come into contact with oral tissues or skin. Wear mask, goggles and procedure gloves when handling the product. The patient should wear goggles during the procedure. Avoid contact of phosphoric acid with mucosa, skin and eyes. It can cause burns. In case of contact, wash immediately with plenty of water. If necessary, consult a physician. Apply a thin layer of the product to bond the bracket to the tooth enamel surface. Thick layers can impair adhesion. The patient should be advised to contact the dentist in case of detachment of the bracket. In case of bracket swallowing, consult a physician. A minimum intensity power of 400 mW/cm2 is required for the light curing unit. Equipment with lower intensity power should require longer photoactivation periods. Do not use the product after its expiration date. Do not reuse empty package. Keep out of reach of children. Single use product After polymerization the product cannot be used again; the procedure must be redone.
CONTRAINDICATIONS:
Do not use the product in patients with unsatisfactory dental health (biofilm,
dental calculus, periodontal disease and caries lesion). These are clinical
conditions that restricts the indication of orthodontic treatment Do not use
in patients with hypersensitivity to the components of the product.
ADVERSE EFFECTS:
As the product is to be used at dental enamel only, no side effect is
expected if the product is used according to the instructions.
STORAGE CONDITIONS:
The package should be closed immediately after use. Store the product in its original package and in a clean and dry place. Do not expose the product to high temperatures or intense light Store it at temperatures between 5 °C/41 °F and 30 °C/86 °F. Do not freeze the product. Protect the product from external contamination. Do not store the product near Eugenol-based materials, as they inhibit proper polymerization of the product.
TRANSPORT CONDITIONS:
The package must be transported at temperatures between -20 °C/-4 °F and 55
°C/131 °F. Do not expose the product to intense light. Keep in a clean and dry
place. Do not transport the product near Eugenol-based materials.
DISPOSAL: The product must be disposed of according to the legislation in
force in your country.
Symbology
| Keep dry.
---|---
| Manufacturer.
| Consult instructions for use.
| Batch code.
| Keep away from sunlight.
| Use – by date.
| Catalogue Number.
| Consult instructions for use for important preventive information.
| Do not re-use.
| Temperature limit
MADE IN BRAZIL Fabricante | Manufacturer:
Maquira Indistria de Produtos
Odontologicos S.A.
CNPJ: 05.823.205/0001-90
Endereco | Direccion Address:
Av. Melvin Jones, 773
Pq. Ind. Bandeirantes
Maringa – PRI87070-030 | Brasil
5. Técnico | Technical Resp.
Cristiane Furlan | CRF-PR: 14.038
Reg. ANVISA N°: 80322400090
SAP:
Atendimento ao cliente Atencién al cliente
Customer service 0800726 5848
sap@maquira.com.br
0403049 – rev. 06
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