SMILE

YOUR

WHITEST is only 30 minutes away

A

B

C

WHITENING TREATMENT SESSIONMOUTHCHECK-PRELIMINARY CLEANINGA) Mouth checkBefore starting the EZ White™ Pro In-Office Whitening System, the dentist should perform a comprehensive dental examination of the patient. It is recommended that a dental cleaning be performed which may be done using polishing powder. A1) WHITE TONE ANALYSISPRE-TREATMENT – WHITE TONE ANALYSIS OF THE CURRENT TOOTH COLOR AND EVALUATION OF THE COLOR USING THE VITA SCALE (**) updated according to the following sequence: B1, A1, B2, D2, A2, C1, C2, D4, A3, D3, B3, A3.5, B4, C3, A4, C4 –• The color code is taken matching the patient’s teeth, and the code is recorded before starting the whitening treatment.• At the end of the treatment, repeat the matching of the new tooth color with the corresponding grade level on the VITA Scale.• The new color code of the whitened teeth may vary from patient to patient. This will depend upon age, lifestyle, and intrinsic staining (tetracycline, amalgam). Smoking, coffee, and red wine stains tend to respond well to the whitening treatment, however these can affect efficacy of EZ White™ Pro.• Once the EZ White™ Pro whitening treatment has been completed, patients may notice further whitening of the teeth within 24 to 36 hours after treatment.• As a final result, the patient will be able to demonstrate an extraordinarily whiter and shinier smile.(**) Vita® is a registered Trademark of the VITA Zahnfabrik H. Rauter GmbH & Co. KG, Bad Säckingen, Germany. WHITENING GEL PREPARATIONB) Whitening gel preparationWARNING: Always wear protective gloves and glasses because of handling of hydrogen peroxide at 39% (final concentration in active gel: 29%).From the kit, take the syringe cylinder containing the powder. This syringe has been designed:• to allow the preparation of the whitening gel full treatment dose directly in the syringe body;• to allow a precise ergonomic application and dosage of the gel onto the teeth.1. Take the EZ White™ Pro powder mix syringe and remove its small lid.2. Take the ampule of EZ White™ Pro hydrogen peroxide, add all of its contents to the syringe containing the powder, holding the ampule in a vertical position. Once empty, discard in the container for special disposal. Follow local governing ordinances for correct disposal.3. Take the small mixing spatula. With this, combine (stir well) the powder with the liquid, making sure the mixture has no lumps of powder remaining in the syringe bottom or lateral sides. Mix for 20 seconds until a soft viscous, creamy, and homogenous gel is obtained. The ready-to-apply gel must hold its shape when extruded from the syringe. Once EZ White™ Pro whitening gel is ready, it will be a brilliant orange color. NOTE: The concentration of the peroxide in the EZ White™ Pro whitening gel is now reduced to 29%.4. Once the gel is prepared, it must be used within one hour from its preparation time. DISPOSE PROPERLY: Once all operations of the treatment have been completed, dispose of the gel whitening syringe in the proper container. 5. Take the white blunt needle from the small plastic bag; remove the syringe cap and insert the needle. Make sure to twist it correctly to lock it.6. Take the bar piston of the syringe from the kit and insert it in the body of the syringe. Placing the syringe on a gauze square, press the piston very slowly, letting the air evacuate, and concentrating the gel mass towards the bottom of the syringe, free of any air bubbles and ready for extrusion on the patient’s teeth.7. Before starting the bleaching treatment, the operator can first try a micro extrusion of the gel on the gauze square, to test the ergonomics of the action and determine the ideal pressure to use to extrude small quantities.NOTE: Because of EZ White™ Pro’s particularly fast and mild treatment, it is not necessary to use cream to protect the facial tissues from exposure to the light. The dentist will insert the appropriate cheek retractors in the patient’s mouth and needed cotton rolls under the lips, avoiding the danger of any accidental contact of lips with target teeth.

GINGIVAL ISOLATION PREPARATIONC) EZ White™ Pro active shield preparationThe barrier gel contained in the EZ White™ Pro active shield syringe is ready for use. Its application and correct polymerization guarantees a precise isolation of the gingival tissues bordering the teeth that will be covered with the whitening gel.EZ White™ Pro active shield syringe preparation:• Take the EZ White™ Pro active shield black syringe.• Remove the small cap covering the tip of the syringe.• From the small bag, take the black blunt needle with the bent extruder. Insert the needle into the tip of the syringe.Make sure to twist it correctly to lock it into place. C1) Application and photo-polymerizationAPPLICATION AND PHOTO-POLYMERIZATION OF THE EZ White™ Pro ACTIVE SHIELD GINGIVAL GELBefore beginning the whitening treatment, it is essential to completely and accurately isolate the soft tissues around the teeth to be whitened.• Using the syringe, extrude a thin thread of the gingival barrier gel around each tooth to be whitened in the maxillary arch along the gingival margin. Ensure the soft tissue of the gingival margin is completely covered. For added safety, protection can be extended to one tooth beyond the destined whitening zone. The syringe contains enough gingival barrier gel to repeat and reinforce the protection of the gums, if needed.• Once the barrier gel has been applied, its hardening (polymerization) is initiated by using a normal dental office curing lamp. Use standard practice to alternate the phase of gingival barrier gel application and curing.• After having completed application of the gingival barrier gel in the maxillary arch, repeat the same operation on the mandibular arch.

RECOMMENDATIONIt is necessary to limit the exposure to the curing lamp light, no more than a few seconds on a single area needing polymerization, by continuously moving the lamp right and left, and then going back again if necessary:• Stop the light supply immediately after the barrier gel has hardened.• Verify that all the barrier gel has correctly hardened and that the protection has been well applied, as prescribed by any gingival protection protocol.

A) Mouth check

B) Whitening gel preparation

C) EZ White ™ Pro active shield preparation

C1) Application and photo-polymerization

EZ White™ ProHYDROGENPEROXIDE

EZ White™ ProPOWDER MIX PHOTOACTIVE BOOSTER

D2) Whitening gel removal

D1) Whitening gel activation

F) Color evaluation

E) Gingival barrier gel removal

D

D1

D2

D3

E

F

WHITENING TREATMENT PROTOCOLD) Whitening gel application1. Make certain that the blunt needle of the syringe containing the whitening gel is in place.2. Before starting the application, make sure that the protective gingival barrier gel has undergone the proper application and polymerization.3. Apply the EZ White™ Pro whitening gel on all teeth designated for whitening: gently push the syringe piston to accurately extrude the gel onto the tooth’s external visible side. Make certain that the gel application is done homogeneously and that the layer of the whitening gel is thin: approximately 0.8-1.0 mm. In the case of a misapplication, and a thicker layer of whitening gel than the requirement is applied, use a spatula to remove the excess gel until ideal amount is obtained.4. Start from the maxillary arch and continue onto the mandibular arch. In the following cycle, invert the starting order of the arches, for a more symmetrical balance of results. The whitening gel quantity is estimated to be enough to perform the cycle 6 times on all teeth in both arches (four cycles are the protocol standard for the treatment and the two extra cycles are optional).IF WHITENING GEL TOUCHES LIPS AND/OR SKIN, REMOVE AND IMMEDIATELY APPLY GINGIVAL BARRIER GEL TO REMOVE BURNING SENSATION, LEAVE ON FOR 5 MINUTES AND THEN WIPE OFF.

D1) Whitening gel activationThe activation of EZ White™ Pro whitening gel is obtained using the appropriate dental lamp for polymerization or whitening, available at the dentist’s office, and as described in the EZ White™ Pro instructions for use (point 6). So long as the gel is an orange color, it has not been activated. It is recommended not to leave the non-activated whitening gel on the teeth. Once the EZ White™ Pro whitening gel has been applied on both arches, the procedure of light activation should be started immediately, tooth by tooth. Hold the tip of the dental lamp at a distance of approximately 5 mm from each tooth to whiten.

VISIBLE ACTIVATION CONTROLThe time needed for gel activation on a single tooth with the prescribed light at the right distance depends on a variety of factors such as the type of dental lamp used and its delivered effective power. The activation may require the light beam to be concentrated on each tooth for about 5 to 20 seconds.• The minimum light power required is 800 mW/cm2.• The visible activation control built into EZ White™ Pro whitening gel confirms its activation when it turns from orange to a bubbly white.• At this point, the dentist is advised to immediately go on to activate the next tooth.• The procedure should be repeated until all teeth of one arch are activated. Then the other arch can be activated in the same way.

D2) Whitening gel removalREMOVAL OF EZ White™ Pro WHITENING GELAfter completion of the activation on the last tooth, remove the activated gel from all teeth on both arches using the saliva ejector.In summary, the treatment includes:• Proper application and polymerization of the protective gingival barrier gel.• Whitening gel application in a very thin layer of 0.8-1.0 mm.• Dental lamp light activation should be done at a distance of approximately 5 mm from the tooth, for about 5-20 seconds per tooth.• Use the saliva ejector to remove the activated gel from all teeth. The cycle must be repeated according to the prescribed protocol.

D3) Cycle repetitionFOUR CYCLE PROCEDUREThe EZ White™ Pro protocol and procedure requires the repetition of the following operations: Application, Activation and Removal of the gel. These procedures should be repeated 4 times in a non-stop sequence. A fifth and sixth optional cycle can be carried out, in complete safety, if it is deemed necessary.

PROCEDURAL COMPLETIONE) Gingival barrier gel removalAfter having aspirated the whitening gel of the fourth or the last cycle, it is time to remove the protective barrier using any appropriate dental tool. Aspirate with care and rinse mouth with copious irrigation. DO NOT USE ANY MOUTHWASH CONTAINING FLUORIDE OR CHLORHEXIDINE WHILE RINSING.

WHITE TONE ANALYSISF) Color evaluationPOST-TREATMENT – WHITE TONE ANALYSIS AND COLOR EVALUATION – RESULT COMPARISONAnalyze the new white tone obtained (use VITA Scale). Show the patient the final results, pointing out the quickness and mildness of the treatment. Ask the patient about any sensitivity or discomfort felt during the treatment. Advise the patient that the tone of white obtained right after the treatment is subject to change. Teeth may become whiter within 24-48 hours following the treatment.

HIGH CUSTOMER SATISFACTION• Various interviews with patients have demonstrated the highest level of satisfaction. • EZ White™ Pro has been praised by patients for its surprising combination of speed and results.• By using EZ White™ Pro In-Office Whitening System, a higher level of satisfaction is achieved, even among more demanding clients.

IFU EZ•White Pro In Of fice System

FileNumber B-1

03/28/20 12

Tony Nucera

Black

MULTI-LIGHT ACTIVATED ADVANCED TEETH WHITENING SYSTEMEXTREMEMLY IMPORTANT: PREPARATORY NOTETo ensure patient and dentist safety and to provide optimum system performance, it is essential that all instructions indicated in the following document are carefully read and followed by a dental professional before proceeding with the whitening treatment. Compared to other whitening systems that are photo activated, the EZ White™ Pro In-Office Whitening System offers innovative standards of efficiency due to its unique formula. The precise application of both the protocol and the procedure – phases, time, and cycles – are required.The following paragraphs describe the proper protocols and procedures to be followed to ensure consistent aesthetic results, as well as a high level of comfort for the patient and, more importantly, a significant reduction of risks associated with post-treatment problems of sensitivity. The EZ White™ Pro In-Office Whitening System is quick and easy.

WHEN PREPARING TO USE THE KIT, ALWAYS WEAR PROTECTIVE GLOVES, EYEWEAR, AND FACEMASK1. PRODUCT NAMEEZ White™ Pro MULTI-LIGHT ACTIVATED ADVANCED IN-OFFICE TEETH WHITENING SYSTEMS: A LIGHT-ACTIVATABLE HYDROGEN PEROXIDE BASE GEL WITH SPECIAL PHOTOCHEMICAL MEDIATORS FOR PROFESSIONAL USE ONLY.

2. INTENTION FOR USEEZ White™ Pro In-Office Whitening System is intended only for in-office use by dental professionals and dentists. The kit is designed to always be used in combination with an appropriate light source (a curing dental lamp or a teeth whitening dental lamp as specified in the following paragraphs). The efficiency and safety of this teeth whitening system results from a combination of the kit components and the photochemical reaction of hydrogen peroxide. Driven by the light source, the hydrogen peroxide eliminates superficial teeth stains and allows for whiter, shinier teeth. Achieved shades of white may differ from patient to patient depending on the individual’s current tooth color, age, and dentin coloration, as well as lifestyle habits. The whitening gel, once prepared, must be applied on the external part of every visible tooth. Prior to proceeding with the treatment, gingival barrier gel must be placed around each tooth that will undergo the treatment to protect soft tissue. As with any other tooth whitening product, EZ White™ Pro provides great results on living and non-living teeth, but will no have any effect on porcelain teeth, resin prosthesis, amalgam and composites.

3. KIT COMPOSITIONAn EZ White™ Pro kit contains: • 1 EZ White™ Pro active shield – gingival protection gel. A ready-to-use syringe containing 1.2 ml of metacrilic polymer gel for gingival protection • 1 EZ White™ Pro hydrogen peroxide 39%. A 5 ml ampule of hydrogen peroxide 39% and stabilizers (final concentration in active gel: 29%) • 1 EZ White™ Pro powder mix – photo active booster. A sealed syringe cylinder containing 1.6 grams of blended powders made with thickeners, activators and colorant • 1 Syringe piston. A piston for use with the syringe of the whitening gel • 2 Syringe extrusion needles. Two blunt needles with a luer-lock closure: the black needle is for the EZ White™ Pro active shield syringe and the other needle is for the EZ White™ Pro whitening gel syringe • 1 Spatula. A spatula to prepare the whitening gel, by mixing the powder in the cylinder of the syringe with the hydrogen peroxide • 1 Instructions for use • 1 Retractor (may not be included) • 1 Maintenance kit. EZ White™ Pro Teeth Whitening Pen containing 2 ml of carbamide peroxide gel 15% with instructions for use (may not be included)

4. PRODUCT STORAGEStore the kit at a temperature between 68-77° F/20-25° C in a cool, dry, and if possible, ventilated place.Keep away from any source of sunlight or heat.Does not require refrigeration, however, if stored in a refrigerator, bring the kit to room temperature at least two hours before use.

5. EZ White™ Pro IN-OFFICE WHITENING SYSTEM HIGHLIGHTSIn order to avoid any contact of the whitening gel with the oral soft tissues, apply the gingival barrier gel (patent pending) EZ White™ Pro active shield – around every tooth that will be whitened. The particular photochemical mediators – EZ White™ Pro multi-light photo active booster – contained in the EZ White™ Pro powder mix (patent pending) are designed to absorb light energy coming from various dental curing or whitening lamps. EZ White™ Pro whitening gel is prepared by combining the EZ White™ Pro powder mix with the EZ White™ Pro hydrogen peroxide. Using the application syringe, the EZ White™ Pro whitening gel is then applied on the external and visible part of every tooth that will undergo the treatment. Afterwards, the whitening gel is exposed to appropriate dental lamp light rays; part of the light energy is absorbed from the photochemical mediators that immediately and efficiently transfer the energy to the hydrogen peroxide, providing fast activation that produces specific radicals. Thanks to EZ White™ Pro visible activation control that is present in the EZ White™ Pro gel, the operator is precisely advised when the whitening gel has achieved its full activation. In fact, the gel, which before activation is of an intense orange color and has a true gel feeling, undergoes a complete discoloring and texture transformation once activated. Once fully stimulated, the gel turns to a much lighter and clearer white color (variable tones of white to a very pale orange shade) and becomes bubblier in consistency. The length of time needed for the light beam to activate the gel on each tooth and the speed of the whole whitening process depends on the type of lamp used (as each lamp’s emitted light power and wavelength is different) and the distance of the tip of the lamp to the gel during the treatment. Once activated, the whitening gel must stay on the tooth for only a very short period of time. This allows for increased benefits for the patient: reduction of dehydration problems of the enamel and the substantial reduction of possible discomfort for the patient (rare induction of dentin sensitivity). EZ White™ Pro’s photochemical In-Office Whitening System is favorably distinguishable compared to other brands sold on the market because of the following features. Be reminded that an increase in temperature can potentially harm the tooth and lead to tooth sensitivity. To obtain the best whitening results, EZ White™ Pro protocol requires the repetition of 4 cycles that include: the application, the activation and the removal of the whitening gel from each targeted tooth. The quantity of gel prepared with the kit allows the operator 2 additional optional cycles, for a total of 6 full complete possible cycles. The average total duration to perform the whitening treatment is approximately 30 minutes. For very discolored teeth, the treatment could be repeated after 15 days.

6. EQUIPMENT NECESSARY FOR THE SYSTEM BUT NOT SUPPLIEDThe purchase of a new “special” lamp is not required. For the correct and rapid activation of EZ White™ Pro whitening gel, it is sufficient to use an appropriate dental lamp (a polymerization or whitening lamp).• LED LIGHT• HALOGEN LIGHT• METAL HALIDE LIGHT• PLASMA ARC LIGHTMinimum light power required: 800 mW/cm 2.

LIGHT ACTIVATION TIMEThe optimal activation time for the gel depends on the light power effectively released by the dental lamp equipment. Usually the time varies from approximately 5 seconds up to 20 seconds per tooth.

DISTANCE: The correct distance from the dental lamp tip to the gel waiting to be activated is approximately 5 mm.

IMPORTANT NOTICE: As soon as the gel on one tooth is activated, the light must be moved onto the next tooth. Giving the already activated tooth an extra dental lamp dosage will provide no benefit in terms of whitening effect and may cause possible patient discomfort. An excess of light could introduce non-desirable and unnecessary increasing heat on the patient’s teeth, without improving the efficiency of the whitening process, and neutralizing the advantages of this particular “cold” whitening system.

77°F

68°F

7. WARNING, SAFETY, AND LIMITATIONSAttention. The hydrogen peroxide contained in the kit is corrosive and combustible.ALWAYS WEAR PROTECTIVE GLASSES AND GLOVESAs with any other teeth whitening product, EZ White™ Pro whitening gel:• Acts only on live and non-live teeth.• It does not whiten porcelain teeth, composites, and amalgam.• Advise the patient that at the end of this treatment any existing cosmetic dental work may need to be replaced to match the newly whitened teeth. Wait at least two weeks before attempting to repair, in order to be sure that the teeth have reached their definite and final shade of white.

CONTRAINDICATIONS AND PRECAUTIONSThe ideal patient to undergo this treatment is in good health, is not sensitive to light, does not take medication that is photoactive, does not have salivary calculus and is not affected by melanoma.As with any other whitening system, EZ White™ Pro whitening gel is not recommended:• for use on children under 15 years of age,• for use on pregnant women or nursing mothers,• for anyone who has hypersensitivity to light.In the event that a patient experiences sensitivity, the whitening treatment should be immediately stopped.ALSO:• Do not treat patients with evident gingival problems or untreated periodontal disease.• Do not treat patients that demonstrate an allergy to hydrogen peroxide.• It is suggested not to smoke a few days before the treatment and a few days after the treatment, as in some cases, the peroxide can react with components present in cigarette and cigar smoke.• Keep the kit out of reach of children.• Carefully remove the EZ White™ Pro powder mix syringe’s cap.• Always wear protective gloves and glasses. Carefully add the ampule of hydrogen peroxide to the syringe cylinder containing the powders.• Limited and temporary demineralization of enamel are commonly associated with any whitening system, whether professional in-office or at-home teeth whitening systems.• The value of mineralization of the patient’s teeth naturally adjusts to proper values for reconstructive metabolic natural actions. In case of need, the speed of re-mineralization can be enhanced by providing the patient an appropriate therapy.• Patients that appear to have dental conditions that could provoke sensitivity or that allow for gel penetration inside the tooth (for example: persons with already existing tooth sensitivity, receding gums, exposed dentin, uncovered roots, tooth with micro-fractures, open cavities, loose dental fillings) would be increasingly prone to pain and/or sensitivity after the EZ White™ Pro In-Office Whitening System.

FIRST AIDIN CASE OF ACCIDENTAL CONTACT WITH SKIN OR SOFT TISSUES: Immediately wash and rinse area repeatedly. Apply a mix of baking soda and water on the irritated area, or a cream/oil with a base of Vitamin E. If symptoms persist, immediately consult a medical specialist. CONTACT WITH EYES: Open eyes and wash with running water for 15 minutes. If symptoms persist, immediately consult a medical specialist.

INGESTION: In the case of accidental ingestion, rinse mouth with water and gargle with salt water. If symptoms persist, immediately consult a medical specialist. INHALING OF THE POWDERS: Breath in the open air. If symptoms of respiration difficulties persist, immediately consult a medical specialist.

8. PRELIMINARY OPERATIONSPRELIMINARY SESSION FOR THE PATIENT: BEFORE BEGINNING THE TREATMENT

A few days prior to the EZ White™ Pro In-Office Whitening System treatment, the dental professional should perform a comprehensive examination. It is recommended that any pathology, including decayed and rotten teeth, be resolved before whitening is performed.

In summary:• Precise history background;• Accurate and objective examination;• Removal of other dental pathological conditions.

As with any other whitening treatment, optimal EZ White™ Pro In-Office Whitening System performance depends upon the application of gel on clean teeth without obstruction of tartar/plaque. Consequently, in the preliminary session with the patient, it may be necessary that the patient undergo a thorough dental cleaning and polishing. The whitening treatment should be performed soon after, before reformation of new tartar/plaque.

Manufacturer: OraPharma, Inc.700 Route 202/206 NorthBridgewater, NJ. 08807

For professional inquiries or questions, please call our Customer Care Center at 1-866-273-7846 from Monday through Friday, 8:30 am to 5:00 pm ET.

EZ White™ is a trademark of OraPharma, Inc.

©OraPharma, Inc. 2013

KUS-IFU-001 04/13

WARNING: FOR PROFESSIONAL USE ONLYSTORE BETWEEN 68-77°F/20-25°C. DO NOT FREEZE

IFU EZ•White Pro In Of fice System

FileNumber B-1

03/28/20 12

Tony Nucera

Black