maQuira IMPRESSION AD Addition Silicone Instruction Manual

IMPRESSION AD – Addition Silicone

DESCRIPTION

Impression AD is an addition silicone-based impression material, suitable for precision impression taking of preparations for inlays, onlays, crowns and multi-unit prosthetics, molding for removable partial dentures, full dentures and implants, and can be used in the dual molding or simultaneous molding technique. Together, the putty paste and the fluid paste provide precise moldings. The contrasting colors of the Impression AD line allow for easy-to- view oral impressions after setting, in addition, the excellent dimensional stability and high detail reproduction lead to stable and faithful impressions of the entire molded region.

INDICATION OF USE

Impression AD is suitable for precision impression taking of preparations for inlays, onlays, crowns and multi-unit prosthetics, molding for removable partial dentures, full dentures and implants, and can be used in the dual molding or simultaneous molding technique.
PRESENTATION

• Impression AD Putty Box with 01 pot of Impression AD Putty (Base) with 300 mL, 01 pot of Impression AD (Catalyst) with 300 mL and 02 measuring spoons.
• Impression AD Regular Body Box with 01 cartridge of Impression AD Regular Body with 50 mL, 06 mixing tips and 02 intraoral tips.
• Impression AD Light Body Box with 01 cartridge of Impression AD Light Body with 50 mL, 06 mixing tips and 02 intraoral tips.
•  Impression AD Putty + Regular Body Box with 01 pot of Impression AD Putty (Base) with 300 mL, 01 pot of Impression AD Putty (Catalyst) with 300 mL, 02 Impression AD Regular Body cartridges with 50 mL each, 06 or 10 mixing tips, 02 intraoral tips and 02 measuring spoons.
• Impression AD Putty + Light Body Box with 01 pot of Impression AD Putty (Base) with 300 mL, 01 pot of Impression AD Putty (Catalyst) with 300 mL, 02 Impression AD Light Body cartridges with 50 mL each, 06 or 10 mixing tips, 02 intraoral tips and 02 measuring spoons.

COMPOSITION

Base Paste: Silicon Polymers, Vaseline, Silica, Titanium Dioxide, Magnesium Silicate, Fillers, Pigment and Flavoring. Catalyst Paste: Silicon Polymers, Vaseline, Silica, Titanium Dioxide, Magnesium Silicate, Fillers and Pigment.
MODE OF USE
Loading and Operating the Impression AD Regular Body and Impression AD Light Body Dispenser/Application Pistol:

1. Position Impression AD Regular Body or Impression AD Light Body in the Dispenser/Pistol. Close the cartridge retainer positioned at the top of the Dispenser.

2. Before dispensing, check that both cartridge openings are not obstructed. Dispense a small amount of molding material until the base and catalyst pastes emerge simultaneously and evenly, then attach a yellow mixing tip to the cartridge.

3. For intraoral use of Impression AD Regular Body or Impression AD Light Body, attach a yellow intraoral tip to the mixing tip. If necessary, shorten the intraoral tip with a scalpel in order to increase the paste exit opening and facilitate material extrusion.
   Note: Use moderate pressure and push the blind end of the intraoral tip onto the mixing tip. A click will be heard when the intraoral tip is locked in position. Alternatively, dispense Impression AD Regular Body or Impression AD Light Body into an intraoral syringe.

4. Ensure that the base paste and catalyst paste are thoroughly mixed and that the dispensed paste is uniform in color. Paste color: see “Forms of Presentation – available colors”. Do not force the polymerized material out of the mixing tip. Excessive force may damage the cartridge and mixing tip, resulting in material spillage.

5. Remove unpolymerized paste with a cloth soaked in alcohol.

Printing procedures: simultaneous technique, double technique and triple tray technique. A) Simultaneous Printing Technique Recommended Materials:

• Impression AD Light Body or Impression AD Regular Body.
• Impression AD Putty and Impression AD Light Body or Impression AD Regular Body.

1. Select or prepare a rigid tray of sufficient size and wall height to accommodate 2-3 mm thick impression material around the teeth.

2. Apply a thin layer of tray adhesive to tray and allow to air dry (5-15 minutes). Prepare teeth, isolate. In case of subgingival preparations, place retraction wire(s) if needed.

3. Dispense Impression AD Regular Body or Light Body directly with the aid of an intraoral tip attached to the mixing tip or with an intraoral syringe of your choice.

4. Remove equal volumes of Base Paste and Catalyst Paste from the Impression AD Putty package with the respective spoon. Fill the measuring spoon up to the edge (flat spoon).

5. Simultaneously with removal of the retraction wire(s) (in case of subgingival preparation) and injection of Impression AD Regular Body (or Light Body) around the clean and dry dental preparation, the dental assistant must manipulate the Impression AD Putty Base and Catalyst pastes manually with the fingers for 30 seconds until a homogeneously colored paste free of streaks is obtained. Mixed Impression AD Putty should then be placed in a tray coated with the adhesive. Hat Certain gloves inhibit the setting time of the silicone. Test gloves to confirm proper setting times. Use vinyl gloves or vinyl coatings. Then remove gloves, wash and dry hands thoroughly to remove potential sources of contamination such as glove residue and hand lotions.

6. Make a groove-shaped relief in the heavy paste in the region to be printed, in a proportional area the size of three teeth. Fill the channel with Impression AD Regular Body or Impression AD Light Body.
   Note: Dispense the material with vibratory movements, keeping the intraoral tip immersed to prevent incorporation of bubbles and ensuring adhesion and complete coverage of the prepared surfaces.

7. Introduce the tray slowly into the mouth with unpolymerized Impression AD Regular Body (or Impression AD Light Body). Introduce the tray parallel to the prepared teeth.
   Note: The tray must be placed within 60 seconds after the regular setting fluid material has been dispensed into the mouth, a and within 60 seconds after completion of mixing Impression AD Putty. Do not exceed the working times of materials in order to avoid incomplete or inaccurate impressions.

8. Hold the tray in position in the mouth without exerting pressure until the materials have completely cured (up to 5 minutes).

9. Once set, remove the impression tray from the mouth. Apply downward pressure along the edges of the tray to release the impression seal and remove the tray.

10. Visually inspect the impression for defects or tears. Thoroughly examine and explore the groove of the prepared teeth, as well as the underlying teeth and interdental spaces to remove any remaining impression material.

11. Immediately rinse the impression in water and dry.

12. Place the impression in a 2% glutaraldehyde-based or dual or synergistic quaternary agent-based disinfectant solution for the period of time recommended by the manufacturer. The disinfection time depends on the manufacturer’s instructions. Do not keep the impression submerged in the disinfectant solution for a period longer than recommended, otherwise it may be damaged. Once the disinfection process is complete, rinse any residual disinfectant solution present on the impression for 15 seconds under running water. 13. The casting models can be performed two hours after setting. To obtain a bubble-free model, wash the impression immediately before pouring and remove excess water, or use a silicone surfactant. Pour the impression with dental Type 3 and Type 4 plaster. Impression AD impressions are stable and the casting models can be performed up to two weeks after impression taking.

13. Impressions must be shipped in appropriate packaging to avoid distortion and contamination.
    B) Dual Printing Technique Recommended Materials:
    • Impression AD Light Body or Impression AD Regular Body.
    • Impression AD Putty and Impression AD Light Body or Impression AD Regular Body.

Step 1. Way preparation / Preliminary Impression with Impression AD Putty

1. Select or prepare a rigid tray of sufficient size and wall height to accommodate 2.3 mm thickness of the impression material around the teeth.

2. Brush a thin layer of tray adhesive onto the fray and allow to air dry for 5-15 minutes.

3. Take equal volumes of Base Paste and Catalyst Paste from the Impression AD Putty package with the respective measuring spoon. Fill the measuring spoon up to the edge (flat spoon). Handle the Impression AD Putty Base and Catalyst pastes manually with your fingers for 30 seconds until a homogeneous, streak-free paste is obtained. Mixed Impression AD Putty must then be placed in a tray coated with the adhesive.
   Note: Certain gloves inhibit the setting time of silicone. Test gloves to confirm proper setting times. Use vinyl gloves or vinyl coatings. Then remove gloves, wash and dry hands thoroughly to remove potential sources of contamination, such as glove residue and hand lotions.

4. Place a plastic spacer over the mixed paste and insert the tray into your mouth. Maneuver the tray in the mouth to create a 2-3 mm space for the insertion of Impression AD Regular Body (or Impression AD Light Body).
   Note: The tray should be held in position for 60 seconds after completion of mixing of the paste. Once in position, the tray can be left in the mouth until set is complete (up to 5 minutes) and then removed. To save time, the tray can be removed before the set is complete and left on the bench until the set is complete for at least 10 minutes.

5. Remove the spacers. Clean and dry the impression carefully in order to ensure optimal coalescence of the two materials. If 2 mm of space is not available throughout the impression, remove excess polymerized Impression AD Putty paste with a sharp drill until adequate space is achieved. Make sure that the Putty paste is clean and dry.

6. Prepare the teeth, isolate. For subgingival preparations, if necessary, place retraction wire(s).
   Step 2. Final Print

7. Dispense Impression AD Regular Body or Light Body into the preliminary impression with polymerized Impression AD Putty.
   Fill the entire arch using a stirring motion and keeping the applicator tip immersed in the material to avoid embedding bubbles.
   Note: If the time between removing the impression with Impression AD Putty and starting the application of Impression AD Light Body or Regular Body is longer than 30 minutes, the surface of the material should be roughened with a stiff brush or drill before the procedure to ensure proper adhesion with the fluid material.

8. Remove the retraction wire(s) (in case of subgingival preparation). If necessary, inject Impression AD Regular Body or Impression AD Light Body into the clean and dry preparation while keeping the intraoral tip immersed in the paste to avoid air bubbles and ensure complete adhesion and coverage of the prepared surface.

9. Put the preliminary impression back in the mouth, taking care to avoid the contact of the teeth with light cured Impression AD Putty. Maintain its positioning. Once set, remove impression tray from mouth. Note: The tray should be inserted and in place within 60 seconds of the Impression AD Light Body or Regular Body of regular setting. Hold tray in mouth without applying pressure until materials have fully cured (up to 5 minutes for Impression AD Light Body or Impression AD Regular Body).

10. Apply downward pressure along the tray margins to release the impression seal and remove tray.

11. Visually inspect the impression tray for defects or tears. Examine and thoroughly explore the groove of the prepared teeth, as well as the underlying teeth and interdental spaces to remove any remaining impression material.

12. Immediately rinse the impression in water and dry.

13. Place the impression in a 2% glutaraldehyde-based or dual or synergistic quatemary agent-based disinfectant solution for the period of time recommended by the manufacturer. The disinfection time depends on the manufacturer’s instructions. Do not keep the impression submerged in the disinfectant solution longer than recommended, otherwise it may be damaged.
    Once the disinfection process complete, rinse any residual disinfectant solution present on th impression for 15 seconds unde running water.

14. The casting model can performed two hours after setting. To obtain a bubble-free model, wash th impression immediately befor pouring and remove excess water, o use a silicone surfactant. Pour th impression with dental Type 3 and T 4 plaster. Impression AD impression are stable and the casting models can be performed up to two weeks afte impression taking.

15. Impressions must be shipped in appropriate packaging to avoid distortion and contamination.

C) “Triple Tray” Printing Technique:
This type of impression taking recommended for patients who hay occlusal stability.

1. Assess whether the patient ha occlusion at maximum intercuspation.

2. Insert the tray in the mouth and have the patient bite down firmly in thi position with the tray in the mouth ensuring that he/she can close fully in maximal intercuspation.

3. Center the teeth in buccolingual direction between the tray walls. Mak sure that the most distal tooth extend beyond the posterior margin of th tray.

4. Remove the tray from the mouth and apply tray adhesive for efficien mechanical retention. Apply th adhesive only to the tray walls and no to the mesh. Allow to air dry for 5 to 15 minutes.

5. Fill the entire arch and margins with Impression AD Light Body or Regula Body with vibrating movements keeping the intraoral tip immersed to prevent embedding of bubbles and ensuring complete adhesion and coverage of prepared surfaces. U intraoral tip (if necessary, cut a part o the tip with a scalpel in order facilitate the extrusion of the material)

6. Take equal volumes of Base Past and Catalyst Paste from th Impression AD Putty packaging with the respective measuring spoon.
   Fill the measuring spoon up to the edge (flat spoon). Simultaneously with removal of the retraction wire(s) (in case of subgingival preparation) and injection of Impression AD Light Body or Regular Body around the clean and dry dental preparation, the dental assistant must manipulate the Impression AD Putty Base and Catalyst pastes manually with the fingers for 30 seconds until a homogeneously colored paste is obtained, free of streaks.

7. Load the triple tray with Impression AD Putty. Position the loaded tray on the preparation, supporting the passive screen with the index finger underneath when inserting the tray to ensure that the impression material is loaded evenly on both sides of the tray. Ask the patient to close his or her mouth in the maximum inter-cuspal position previously tried out Evaluate the lateral control side to ensure proper closure. During the procedure, make sure that the patient’s tongue is not causing lingual interference.

8. Keep the tray in position in the mouth without exerting pressure until the materials have completely polymerized (up to 5 minutes).

9. Apply downward pressure along the tray margins to release the impression seal and remove the tray.

10. Visually inspect the impression tray for defects or tears. Examine and thoroughly explore the groove of the prepared teeth, as well as the underlying teeth and interdental spaces to remove any remaining impression material.

11. Immediately rinse the impression in water and dry.

12. Place the impression in a 2% glutaraldehyde-based or dual or synergistic quaternary agent-based disinfectant solution for the period of time recommended by the manufacturer. The disinfection time depends on the manufacturer’s instructions. Do not keep the impression submerged in the disinfectant solution longer than recommended, otherwise it may be damaged.
    Once the disinfection process is complete, rinse any residual disinfectant solution present on the impression for 15 seconds under running water.

13. The casting model can be performed two hours after setting. To obtain a bubble-free model, wash the impression immediately before pouring and remove excess water, or use a silicone surfactant. Pour the impression with dental Type 3 and Type 4 plaster. The moldings with silicones from the Impression AD line are stable and can be perfomed up to two weeks after impression taking.

14. Impressions must be shipped in appropriate packaging to avoid distortion and contamination.

Using the Automix cartridge Insert Cartridge

1. Press the lever at the back of the dispenser/pistol upward and pull the slide all the way back.
2. Pull up the plastic latch, insert the cartridge and lock with the plastic latch.
   Note: Make sure that the grooves on the cartridge match those on the dispenser/pistol.

Apply the mixing nozzle

1. Remove and discard the used cartridge cap or mixing nozzle after 90° counterclockwise rotation.
2. Apply a new mixing nozzle.

Note: Make sure that the grooves on the mixing nozzle match those on the cartridge.

1. Lock the mixing nozzle by turning it 90° clockwise.
   Material application 1. On the first use of a cartridge expel a pea-sized amount of material and discard.

2. Mix the material by pressing the lever on the dispenser/pistol into the mixing tip and apply directly.

Note: Keep the mixing tip used after application in the cartridge to serve as a cap.
Removing the cartridge

1. Press the lever on the back of the dispenser/pistol upward and pull the slide all the way back.
2. Pull up the plastic latch and remove the cartridge.

Using the dual body syringe

1. Before applying the mixing tip remove the cap or used mixing tip by turning it 90° counterclockwise and discard.
2. Apply a new mixing tip. Note: Make sure that the grooves on the dual barrel syringe match those on the mixing tip.
3. Lock the tip by turning it 90° clockwise.
4. On first use of a syringe expel a pea-sized amount of material and discard.
5. The material is mixed in the tip during expulsion and can be applied directly. Note: Keep the used mixing tip after application in the dual barrel syringe to serve as a cap.

TIMING Impression AD Putty:

• Working time (19 – 23 °C): 1 min -1 min 30 s

• Setting time (intraoral temperature – 36 °C): 2 min 30s-5 min
  Impression AD Regular Body:

• Working time (19 – 23 °C): 1 min 30 s- 2 min 30 s

• Setting time (intraoral temperature – 36 °C): 2 min 30 s – 5 min
  Impression AD Ught Body:

• Working time (19 – 23 °C): 1 min 30 s – 2 min 30 s

• Setting time (intraoral temperature – 36 °C): 2 min 30 s – S min
  Preparing the Provisional Warning: The times indicated apply at the specified temperatures and a relative humidity of 50%. Higher temperatures reduce these times and lower temperatures increase them.
  WARNINGS

• The product is indicated for professional use only.

• Polysiloxane vinyl molding pastes cannot be combined with condensation silicones or polyether-based molding materials.
  Even minute amounts may affect the setting reaction.

• Disposable latex gloves inhibit the setting of silicone molding pastes. Vinyl gloves are therefore more suitable.

• The moldings must not under any circumstances come into contact with liquids containing solvents. This could result in deformation (expansion) and distortion of the models.

• Do not use the product after its expiration date. For disposal, follow the legislation of your country.

• Do not reuse empty packaging.

• Keep out of reach of children.

PRECAUTIONS

• Prevent contamination of Impres-sion AD silicone line or contact surfaces with chemical compounds that may inhibit or retard its setting, such as residues of acrylates and methacrylates, latex rubbers, and sulfur compounds.
• Completely remove the oxygen-inhi-biting layer of composite resins (e.g. in restorations or core build-ups), as this may affect or delay the setting of silicone impression pastes. • Retain the mixing tip with polymeri-zed material in the cartridge until its next use. Removal and replacement of a worn mixing tip may lead to paste transfer and subsequent clogging.
• For reusable trays, the tray adhesive may be removed with acetone.
• In case of allergy, discontinue use immediately and advise the patient to seek medical attention.
• Wear mask and procedure gloves when handling the product.
• Avoid contact with eyes. Wear protective glasses when handling the product. In case of contact, wash immediately with plenty of water. If necessary, consult a physician.
• Avoid prolonged or repeated contact with the skin. It is recommen-ded to use the “no-touch” technique. In case of contact with skin, wash immediately with plenty of water. If necessary, consult a physician.
• Avoid ingestion. Wash hands after handling and before eating.
• Use in a well-ventilated area.

CONTRAINDICATION
Do not use Impression AD in patients with hypersensitivity to the formula components.
ADVERSE EFFECT Up to now no adverse effects of the product have been identified. No side effects are expected if the product is used according to instructions.
STORAGE CONDITIONS

• Store the product in its original packaging and in a clean, dry place.
• Do not expose the product to high temperatures. Store it at room temperature between 15 °C / 59 °F and 25°C / 77°F under a maximum relative humidity of 80%.

VAUDITY
The expiration date on the packaging represents the maximum time the product can be used. Do not use after the expiration date.

DISPOSAL

Do not reuse the product and dispose of it according to local legislation.

Symbology

| Keep dry.
---|---
| Manufacturer.
|  Consult instructions for use.
|  Batch code.
| Keep aviay fro-m sunlight.
|  Use – by date.
| Catalogue Number.
| Consult instructions for use for important preventive information.
|   Do not re-use.
| Temperature limit.

Fabricante I Manufacturer:
Maguire Industrie de Produtos
Odontologicos S.A.
CNPJ: 05.823.205/0001-90
Endereco I Direccion I Address:
Av. Melvin Jones, 773
Pq. Ind. Bandeirantes
Maringe – PR 187070-030 I Brasil
Resp. Tecnico I Technical Resp.:
Cristiane Furlan I CRF-PR: 14.038
Reg. ANVISA N°: 80322400144
SAP:
Atendimento ao cliente
Atencion at cliente
Customer service
0800 726 5848
sap@maquira.com.br
0403118 – rev. 05

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