CLASS IIa MEDICAL DEVICE

In-Office Tooth Colour Restoration System

Pola Office+ is a hydrogen peroxide-based dental device for professional in-office use, supplied as a dual-component gel in a double-barrel syringe, mixed during application. The active ingredient of the mixed gel, hydrogen peroxide, penetrates the tooth structure and oxidises chromogenic compounds responsible for intrinsic discolouration, supporting restoration of natural tooth colour in clinically indicated cases.

Intended Use

Pola Office+ is used to restore the natural tooth colour in internally discoloured vital and non-vital teeth, which can only be done safely in the controlled environment of a dental practice in the case of difficult access and limited patient compliance.

Pola Office+ is a hydrogen peroxide-based system for restoring tooth colour in the dental office with minimal time.

The gel is pH neutral and contains potassium nitrate for maximum patient comfort. It is mixed in a dual-chamber syringe and can be easily and precisely applied directly to the tooth surface to be treated.

Indications For Use

• Pola Office+ 37.5% is used for the controlled, medically indicated restoration of natural tooth colour in discoloured, vital and devitalised teeth, whose natural or normal colour cannot be restored by professional tooth cleaning.
• Medical restoration of natural tooth colour is indicated when pathological tooth discolouration affects the patient’s health-related quality of life.
• Medical restoration of natural tooth colour is also an alternative to much more invasive conservative or prosthetic treatments of the affected teeth (fillings,  crowns, veneers) and should therefore always be the first choice.
• The causes of such internal discoloration are, for example:
  discolouration caused by tetracycline/minocycline, mild to severe dental fluorosis (TF index > 2), devitalized teeth (pulp necrosis), e.g. due to trauma, genetic or age-related degenerative discolouration, porphyria or jaundice, strong deposits of food dyes with penetration into the tooth substance (internal discoloration due to external dyes).
• The product supports the restoration of natural tooth colour in single and multiple teeth, including endodontically treated de-vital teeth, including intracoronal treatment.

Contraindications

• Do not use on pregnant or lactating women.

• Do not use on children under 18 years of age.

• Do not use on persons having known sulphur allergies

• Do not use Pola Office+ on any persons having known peroxide allergies.

• Do not use on patients with extremely sensitive teeth.

Side Effects

• Possible transient soft tissue irritation if the Gingival Barrier is not applied correctly to prevent product from contacting the soft tissue.
• Some patients may experience soft tissue swelling, redness, tenderness. These side effects are generally temporary. Clinicians should monitor for these potential reactions and manage appropriately.
• Ensure appropriate gingival protection prior to application.

Interactions

• Pola Office+ does not alter the colour of existing restorative materials (e.g.  composites, glass ionomer cements, ceramics); colour mismatch may occur following treatment.
• Residual oxygen after treatment may temporarily inhibit polymerisation of resin-based materials (e.g. adhesives, composites). Delay restoration placement for 2 to 4 weeks after treatment.
• Concomitant use with other peroxide-containing products may increase the risk of tooth sensitivity and soft tissue irritation.
• Post-treatment exposure to chromogenic substances (e.g. coffee, tea, red wine, tobacco) may affect colour stability.

  Additional notes

Pola Office+ syringe and tips are for single use only. Reuse will result in patient cross contamination.

Storage And Handling

• Store product in the refrigerator 2 – 8 °C (35 – 46 °F).
• Use product at room temperature.
• Do not remove syringe from foil until ready to use – Pola Office+ is heat and light sensitive.
• Do not use if the foil appears to be bloated.

  High concentration hydrogen peroxide (mixed gel concentration 30.4%). May cause tooth sensitivity, soft tissue irritation or chemical burns.

Precautions

• For professional use only. Use only by trained dental professionals.
• Keep out of reach of children.
• Do not take internally.
• Do not use after expiration date.
• Pola Office+ syringes may be under pressure – remove cap and attach nozzle with caution
• Avoid contact with soft tissues, skin and eyes.
• Patient must wear protective eyewear.
• Operators must wear gloves and protective eyewear.
• Do not allow Pola Office+ gel to come in contact with skin, eyes and soft tissues.
• SDS available at sdi.com.au or contact your regional representative.

First Aid

Eye (contact): Open the eye wide and thoroughly wash for 15 minutes with running water. Seek medical attention.

Skin (contact): Immediately wash thoroughly with water. Seek medical attention if symptom persists.

Ingestion: Do not induce vomiting. Rinse mouth with water. Contact local poisons center.

Inhalation: No symptoms expected under normal conditions of use. If affected, move to well ventilated area.

If a serious incident has occurred due to this product, please report this incident to the manufacturer of this product and to the competent authority in your state or country.

Dispose in accordance with local regulations.