The proper use of the OdoBleach gel medicinal product is the medical treatment of teeth with discolorations and teeth containing noxious substances.

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1 Instructions for use A Description elexxion OdoBleach gel is a new dental bleaching gel developed specifically for laser power bleaching using elexxion diode lasers. OdoBleach gel is activated by the lowfocus laser beam delivered by the special therapy applicator that is included in the scope of delivery of all elexxion diode lasers. OdoBleach gel should be used only by dentists or qualified dental office personnel, who must be thoroughly familiar with the content of the present document in its entirety before attempting bleaching treatment. B Indications The proper use of the OdoBleach gel medicinal product is the medical treatment of teeth with discolorations and teeth containing noxious substances. As in any medical treatment, a correct diagnosis must be made before treatment. Although the cause of a specific tooth discoloration may be difficult to ascertain, a detailed medical history and an evaluation of causative factors may assist in a differential diagnosis. OdoBleach gel can be used to bleach one or multiple teeth. This safe and effective product is an excellent agent for bleaching and brightening darkish, yellowish, or decolorized teeth presenting with external or internal discolorations. These discolorations may be extrinsic in nature, caused by tin sulfide deposits, or extrinsic, caused by tetracycline, fluorosis, pulp necrosis, or progressive dentine sclerosis. Prior to bleaching with OdoBleach gel, the teeth should be cleaned (using a glycerolfree agent) and dental prophylaxis performed to remove any plaque and spots. The degree of bleaching that can be achieved will vary from patient to patient, depending on the nature of the discoloration, the thickness of the enamel, the texture of the teeth, and the patient s age. Usually, it is possible to achieve brightening corresponding to 6 to 12 steps on the Vita brightness scale. Teeth with intrinsic grayish discolorations will usually not respond to treatment as favorably as teeth with yellowish discolorations. Dentists are advised to discuss the probable efficacy with the patient prior to embarking on bleaching therapy to make sure the patient s expectations are realistic.

2 C Contraindications Laser tooth bleaching is contraindicated in patients with periodontal disease, exposed root surfaces, damaged or cracked enamel, extensive carious lesions, hypersensitivity to chemical products such as hydrogen peroxide, or similar afflictions. Note: It is recommended to perform an intraoral examination before bleaching. Make sure that the patient has been examined by the dentist and has realistic expectations of the procedure. D Mechanism of action During the bleaching procedure, free oxygen radicals diffuse into the enamel of the tooth as well as into the dentin. These free radicals are extremely electrophilic and unstable; they attack and destroy most organic molecules. E Risks and their causes Before treatment, ask the patient about a possible hypersensitivity to hydrogen peroxide. Make sure that that the patient does not swallow, inhale, or otherwise come in contact with the bleaching powder or the hydrogen peroxide. The gel should always be mixed following the proper procedure and well outside the patient s reach. Once the bleaching procedure has been completed, make sure that the gel is completely removed by vacuum in order to prevent caustic burns in or around the oral cavity. If the packaging of the bleaching set has been damaged in transit, the lid of the powder jar does not fit snugly, or hydrogen peroxide has escaped from the packaging, do not use the bleaching set. Dispose of it properly and in full compliance with all applicable rules and regulations. F OdoBleach gel: Treatment instructions 1 Prepare the laser system by selecting the appropriate settings as per the laser system s Instructions for Use. Turn on the laser to check the system for proper function. 2 Make sure all materials required for the bleaching treatment are present. 3 Do not mix the OdoBleach powder and the hydrogen peroxide until after the patient has arrived. 4 Before treatment, agree on a suitable method for communication with the patient. 5 Keep vitamin E at hand to use with cotton swabs.

3 6 Measure and document the patient s tooth shade using the Vita shade guide. Use the brightness scale shown below. BRIGHTNESS SCALE B1 - A1 - B2 - D2 - A2 - C1 - C2 - D4 - A3 - D3 - B3 - A3.5 - B4 - C3 - A4 - C4 7 Make sure that the patient wears laser protection goggles fitting tightly around the nose for the entire duration of the treatment. If the goggles do not fit snugly, close any persisting gaps with gauze. 8 Keep tissue at hand to wipe off the spatula if needed. 9 Before commencing the treatment proper, place a bite block and a cheek retractor in the patient s mouth and apply petroleum jelly to the patient s lips to keep the soft tissue clear of the teeth. Use cotton rolls for more patient safety and comfort. Do not clean the teeth with flour-of-pumice until after the bite block and cheek retractor are in place. 10 Clean the teeth surfaces using glycerol-free flour-of-pumice slurry. Try to remove dental plaque and superficial stains. 11 Rinse and air dry the teeth and, especially, the gingiva around the teeth to be bleached to prevent the OdoBleach gel from undercutting the liquid barrier during treatment. Make sure that the teeth are dry each time before you apply OdoBleach gel. 12 Mix the OdoBleach powder with the hydrogen peroxide and stir to the desired consistency. 13 Apply gum protector to the gingiva: OdoBleach Liquid Dam isolation 13 a Remove the cap and place the tip firmly onto the OdoBleach Liquid Dam syringe. 13 b Extrude the gum protector (gingival barrier) to apply a stripe of the material approximately 4 6 mm mm in size to the gingiva. Allow the strip to overlap the enamel by approximately 0.5 mm. In the event that excess liquid flows onto the enamel, secure the area with a drying lamp and remove the excess material with a hand instrument. Allow the liquid to extend beyond the last two to be bleached. In case of open interdental spaces, apply the liquid to a tongue depressor and use it to fill the interdental spaces completely, protecting the interdental papillae and the mucous membrane of the tongue. 13 c Once you have applied the protector liquid, cure the liquid using a high-quality drying lamp for 20 seconds per width of the light beam. Clean the teeth with

4 prophylaxis paste to remove excess material. Make sure not to lift or remove the gum protector. 13 d Petroleum jelly can be applied to the mucous membrane in areas not protected by the gum protector. 13 e The syringe and syringe tip are single-use products and must not be reused, as a specific residue in the syringe or syringe tip may constitute a patient hazard. WARNING: Do not perform the procedure without gum protector. 14 Use a spatula to apply a thin layer of OdoBleach gel to all teeth to be bleached. The thickness of the gel should be uniform, with a layer of up to 1.5 mm spread evenly across the teeth. Do not push the gel forward to touch the gum protector. Note: When applying the gel, make sure to keep it away from any contact with the patient s gums, tongue, or lips. Use appropriate precautions to prevent the patient from swallowing the gel. Note: If the patient exhibits a sensitive reaction during treatment, interrupt the procedure and check the patient s health status. DO NOT CONTINUE TREATMENT if sensitivity persists. 15 The operator may apply gel to the patient s teeth a maximum of 4 times during one session. 16 The Instructions for Use for the elexxion diode laser must be followed during dental treatment. Once activated by the laser, allow the gel to soak in for at least 4 minutes. 17 Remove the gel using a high-speed vacuum handpiece and rinse with an air-water syringe to remove all gel residue. If the resulting brightness of the patient s teeth is insufficient, a second, third and fourth gel application may follow at the dentist s discretion. Repeat step 14 through 17 for each of these applications. 18 At the end of the session, wipe off the teeth with gauze and carefully rinse them with water. 19 Remove the gum protector by guiding the tip of an explorer or a pair of pliers between the gum and the barrier. Carefully lift off the barrier. Inspect the spaces between the teeth for any residue using an explorer or dental floss. Repeat the rinse. 20 You may use OdoBleach Desensiting Gel for final polishing to desensitize the teeth and to give them a bright luster. 21 Remove the bite block.

5 22 Measure the shade using the brightness scale of the Vita shade guide. Compare the shades before and after and discuss the result with your patient. 23 Remove the cheek retractor. Note: You may optionally treat irritated tissue with vitamin E after treatment. If additional bleaching is required, a new session may be scheduled after a waiting period of two weeks. G Precautions and warnings The patient and all staff present in the treatment room during the procedure must wear laser protection goggles. Staff members not wearing goggles must not enter the treatment room while the laser is active. The laser protection goggles included with the system are perfectly attuned to the elexxion lasers wavelength, protecting the operator, patient, and all assistants from eye damage caused by the bleaching gel. Protective gloves must be worn throughout the entire bleaching procedure. The bleaching agent may cause caustic reactions on contact with mucous membranes or unprotected epidermal tissue and cause irritation or burns. Should the patient feel unwell or experience a burning sensation at any point during the treatment, interrupt the procedure immediately. Rinse the affected area with a copious amount of water and remove the water using the high-speed vacuum handpiece. DO NOT PROCEED WITH THE TREATMENT if the patient continues to feel unwell or experiences a burning or other unpleasant sensation. Apply vitamin E to the soft tissue areas irritated by the gel. Before the bleaching treatment, discuss expectations with the patient. It is recommended to evaluate the tooth shade before and after treatment. Although OdoBleach gel can be applied up to four times per session, it is quite possible that the desired results can be achieved with only one or two applications. Carefully check the patient record for health limitations such as hypersensitivity to hydrogen peroxide or other oxidants, heart disease, lung disease, bleeding disorders, or immunodeficiencies. OdoBleach gel must not be used in patients with known hypersensitivity reactions to hydrogen peroxide or similar chemicals. When in doubt about the treatment, consult the patient s family physician/general practitioner first. Do not use the liquid barrier in patients with known hypersensitivity reactions to resin. Test the liquid barrier on a small area of the gums before proceeding to the main treatment.

6 When drying the liquid barrier, keep the drying light at least 2 cm away from the resin to avoid heat-induced hypersensitivity reactions during the curing process. The gel must be applied to the teeth evenly and consistently in order to ensure uniform bleaching of the tooth surfaces. Monitor the progress of the treatment, and discontinue treatment the patient complains about not feeling well or experiencing hypersensitivity or if the outcome of the treatment exceeds the desired results. DO NOT anesthetize the teeth for this treatment. When hypersensitivity reactions become manifest, discontinue treatment as described above. Next sure that no bleaching gel is transferred to unprotected tissue from either the working gloves or the dental instruments. Should this happen nevertheless, rinse the affected area with a copious amount of water. Any prosthetic restorations present must be intact. Any exposed dentine areas must be protected before treatment. The shade of the tooth may change back in the direction of the original shade after bleaching. It is therefore recommended to wait two weeks before taking the shade for adjacent restorations, as it may take from several days to two weeks until the new shade has stabilized. For a period of two weeks after the treatment, the tooth shade may change for the positive (brighter) or negative (darker). The shade of existing crowns, fillings, veneers, or other restorative elements will not be affected by bleaching. The dentist should discuss potential cosmetic implications of existing restorations for the outcome of the bleaching treatment with the patient. Excessively calcified areas will bleach more rapidly than adjacent tooth structures. This effect is not always medically demonstrable at the beginning of treatment. Should this effect manifest itself, the gel should be carefully apply to the adjacent regions to adjust the shade accordingly. Patient should be recommended not to consume any products that might discolor the teeth for 48 hours following the end of the treatment session. Examples of such products include certain fruit, coffee, red wine, tomato sauce, tea and tobacco. OdoBleach gel should NOT be used during pregnancy or lactation. Keep the bleaching gel out of the reach of children. Make sure that the bleaching gel is inaccessible to children and all other persons that do not have the required qualifications. OdoBleach gel has been developed

7 specifically for bleaching treatments with the elexxion diode laser. Do not use OdoBleach gel together with other laser units or sources of light. Tooth sensitivity To reduce or avoid tooth sensitivity during or after OdoBleach treatment, the dentist may recommend the intake of appropriate analgesics 30 to 60 minutes prior to treatment and postoperatively. OdoBleach desensitizing gel is also recommended for post-treatment of tooth hypersensitivity reactions. CAUTION: Read these Instructions for Use before treating patients! To be used by dentists only. Avoid contact with the eyes and skin. On contact with the product, rinse the affected area with a copious amount of water. Keep out of the reach of children. Not for injection. Destroy after use. Powerful oxidant elexxion AG. All rights reserved. Revision: 1.00 Revision date: 11 Aug 2010 Use before: See date on the package

8 Manufactured by: Heydent GmbH Spöttingerstrasse Landsberg Germany Distributed by: elexxion AG Laser Technology Schützenstrasse Radolfzell Germany OdoBleach Professional treatment set for laser power bleaching using elexxion diode lasers This set contains: 1 container with pre-portioned OdoBleach bleaching powder 9 ml base H2O2 30% solution 1 syringe with OdoBleach Liquid Dam 1 syringe with OdoBleach Desensitizing Gel 1 tip for the OdoBleach Liquid Dam syringe Desensitizing gel syringe elexxion AG