Professional Whitening Kit Series

Transcription

1 2008 Professional Whitening Kit Series March 22, 2008 Product Profile v7.6

2 INTRODUCTION TO THE BEYOND POWER WHITENING EXPERIENCE Welcome to the world of aesthetic dentistry. Teeth whitening is one of the hottest trends in the dental industry, and one of the most requested services from patients. Everyone wants a Hollywood smile and teeth whitening is the easiest way to noticeably alter the appearance of a smile without dramatic surgery or orthodontics. BEYOND Dental & Health is at the forefront of the aesthetic dental industry. With the development of the BEYOND Whitening Accelerator, our in-office, chair-side power whitening system, we have taken conventional teeth whitening to a whole new level. Safety, convenience, and comfort to both the dentist and the patient were instrumental in the development of our power whitening system. Patient preparation time and total chair time are significantly reduced. Harmful heat and ultraviolet light are filtered out, reducing the risk of patient sensitivity, while powerful, 35% hydrogen peroxide whitening materials guarantee outstanding, glossy-white results. A VARIETY OF WHITENING KITS DESIGNED TO MEET A VARIETY OF NEEDS BEYOND is proud to offer a total of five different whitening kits for chair-side power whitening treatments. Taking into consideration that each patient s pre-treatment situation varies, as well as dentists personal preferences, each kit configuration is designed to meet specific needs. The table below illustrates important differences in the kit configurations and details of each kit follow below. For more detailed information regarding the kit configurations or for recommendations regarding an individual patient, please contact your BEYOND products agent or your nearest BEYOND office. BEYOND is happy to help you choose the most appropriate kit to suit your individual patient needs. BEYOND Whitening Kit Series # of Patients Active Ingredient Treatment Time Prep Materials Included Fluoride Included BEYOND BlueSeal Included RENEW Touch-up Included Works With Other Systems* BEYOND II Premier Single- Patient Kit BEYOND II Complete Single-Patient Kit BEYOND II Five-Patient Economy Kit BEYOND Max5 Treatment Kit BEYOND Max10 Treatment Kit BEYOND Boost 1 35% H 2 O 2 30 min % H 2 O 2 30 min % H 2 O 2 30 min % H 2 O 2 30 min % H 2 O 2 30 min % H 2 O min *Additional treatment cycles may be needed for LED light systems to achieve best results.

3 BEYOND II PREMIER WITH RENEW TOUCH-UP Our most comprehensive kit is the BEYOND II Premier Professional Single-Patient Teeth Whitening Kit. The BEYOND II Premier kit contains everything that you will need to perform the BEYOND treatment, plus an extra syringe of whitening gel for a follow-up, touch-up treatment to be saved and used with the same patient at a later time. The BEYOND II Premier Treatment is a 30 minute chair-side whitening treatment. BEYOND II Advanced Formula Whitening Gel included with the kit contains enough whitening gel for three, 10- minutes cycles, as well as all preparation and isolation materials, and a post-whitening fluoride treatment. Unique to the BEYOND II Premier Whitening kit is the inclusion of the BEYOND RENEW 6% H 2 O 2 whitening formula gel syringe. The RENEW formula is provided inside the Premier Whitening Kit to allow Each BEYOND II Premier Kit contains: 1 1 Dual-barrel syringe of BEYOND II Advanced Formula Whitening Gel (4g/3.5mL) with mixing tip* Syringe BEYOND BlueSeal Gingival Protection (2g/1.6mL) with one metal and one plastic tip 1 Dual-barrel syringe of BEYOND RENEW 6% Formula Whitening Gel (3g/2.5mL) with mixing tip 1 BEYOND FlexiBlue Cheek Retractor 1 BEYOND Pearl White Toothpaste (1.2oz/35g) 1 Jar of sodium fluoride gel (3g/2.5mL) 1 Jar of protective lip cream (2mL) 1 Jar of polishing sand (3g) 2 Cotton rolls 2 Cotton buds 1 Face protection cloth 1 Suction tip for removing gel 1 Patient Consent Form 1 Multilingual Instruction Manual 1 Post-Whitening Care Instruction Card the dentist to perform a touch-up whitening treatment at a later time with the patient without additional cost. The RENEW formula is most often used during the patient s regularly scheduled 6-month checkup. The dentist should simply store the RENEW syringe until the patient s next scheduled visit and at that time perform the touch-up treatment to renew the original whitening results. Alternatively, the RENEW formula can be used immediately following the initial BEYOND treatment on those patients wanting to reach above the commonly achieved B1 shade. To use RENEW to add two to three shades to a BEYOND Power Whitening Treatment, the patient should be scheduled to return about one week following the initial procedure. The RENEW formula is a mild whitening formula for touch-up treatments or to add an additional 2 to 3 shades. The formula does not require the use of a gingival barrier, and each RENEW formula gel syringe contains enough material for two, 10 minutes cycles. Also included in the BEYOND Premier Whitening kit is a post-treatment instruction care card and trialsized tube of BEYOND Pearl White Advanced Formula Whitening Toothpaste with Fluoride. The BEYOND II Premier Professional Single-Patient Whitening Kit is the kit of choice among dentists that

4 prefer to have all the treatment materials available for each patient and intend to provide a touch-up treatment in 3 to 6 months. *BEYOND II Kits can be stored at room temperature. However BEYOND II Advanced Formula 35% H 2 O 2 Whitening Gel syringes are packed outside the kits and must be refrigerated near 5 C during storage. BEYOND II COMPLETE FOR TETRACYCLINE AND SEVERE STAINS The BEYOND II Complete Single-Patient Teeth Whitening Kit for Tetracycline and Severe Stains is our most powerful whitening kit. The BEYOND II Complete kit has long been our most popular single patient kit and is the dentist s favorite for treating darker or grey stains, those caused by antibiotics, and age related stains. Unique to the BEYOND II Complete Kit is the inclusion of an extra-strength, pre-treatment whitening paste used to jump-start the whitening process. A six minute application of the paste formula, followed by three 8-minute applications of BEYOND II Advanced Formula Whitening Gel will render a truly amazing new shade on even the most severe stains. The BEYOND II Complete Single-Patient Teeth Whitening Kit for Tetracycline and Severe Stains is a 30 minute whitening treatment kit. The BEYOND II Advanced Formula Whitening Gel included with the kit contains enough whitening gel for three, consecutive cycles, as well as all the preparation and isolation materials, and post-whitening fluoride treatment. Also included in the BEYOND II Complete Whitening kit is a posttreatment instruction care card and trial sized tube of BEYOND Pearl White Advanced Formula Whitening Toothpaste with Fluoride. As with all tetracycline cases and severe stains, the risk for transient, posttreatment sensitivity is increased relative to more typical stains. Posttreatment sodium fluoride is included to reduce the risk of sensitivity following the treatment. This kit is recommended only for those patients with difficult stains. Each BEYOND II Complete Kit contains: 1 Dual-barrel syringe of BEYOND II Advanced Formula Whitening Gel (4g/3.5mL) with mixing tip* 1 Syringe BEYOND BlueSeal Gingival Protection (2g/1.6mL) with one metal and one plastic tip 1 Bottle of 35% H2O2 liquid (2mL) 1 Jar of catalyst powder (0.7g) 1 Application brush (for manual mix formula) 1 Plastic spatula for mixing 1 BEYOND FlexiBlue Cheek Retractor 1 BEYOND Pearl White Toothpaste (1.2oz/35g) 1 Jar of sodium fluoride gel (3g/2.5mL) 1 Jar of protective lip cream (2mL) 1 Jar of polishing sand (3g) 2 Cotton rolls 2 Cotton buds 1 Face protection cloth 1 Suction tip for removing gel 1 Patient Consent Form 1 Multilingual Instruction Manual 1 Post-Whitening Care Instruction Card

5 Detailed instructions on use of this kit, including the mixing and application of the pre-treatment paste, are also shown on the DVD packaged with the BEYOND Power Whitening Systems. The treatment video can also be viewed online at the BEYOND website. Additional assistance is also offered free of charge for developing individualized whitening plans for those patients with extremely severe cases. *The BEYOND II Complete Single-Patient Teeth Whitening Kit for Tetracycline and Severe Stains can be stored at room temperature. BEYOND II Advanced Formula 35% Whitening Gel syringes are packaged outside of the kit and must be refrigerated near 5 C during storage. BEYOND II FIVE PATIENT ECONOMY KIT Since its launch in 2005, the BEYOND II Five-Patient Economy Kit has become our most popular kit in many markets worldwide. The BEYOND II Five-Patient Economy Kit includes five syringes of the 3.5mL 35% BEYOND II Advanced Formula Whitening Gel, together with five syringes of BEYOND BlueSeal gingival protection. Unlike the Max5 and Max10 kits, the BEYOND II Five-Patient Economy Each BEYOND II Five-Patient Economy Kit contains: 5 Dual-barrel syringes of BEYOND II Advanced Formula Whitening Gel (4g/3.5mL) with mixing tips* 5 Syringes BEYOND BlueSeal Gingival Protection (2g/1.6mL) with 5 metal and 5 plastic tips 5 Jars of sodium fluoride gel (3g/2.5mL) 5 Face protection cloths 5 Patient Consent Forms 1 Multilingual Instruction Manual 5 Post-Whitening Care Instruction Cards Kit also contains five jars of post-whitening fluoride treatment. Each kit also includes patient consent forms, face protection cloths, a multilingual instruction manual, and post-whitening care cards. *BEYOND II Five Patient Economy Kits can be stored at room temperature. BEYOND II Advanced Formula 35% Whitening Gel syringes are packed outside of the kits and must be refrigerated near 5 C during storage. BEYOND MAX5 AND MAX10 TREATMENT KITS The BEYOND Max5 and Max10 kits are the most economical gel formula power whitening kits on the market today. These cost-effective kits offer superior whitening results when used with the BEYOND Whitening Accelerator, but contain additional catalyst for strong performance when used with other lightaccelerated whitening systems. 1 1 Additional cycles may be required for LED systems to achieve optimal whitening results.

6 Quickly becoming popular with cost-conscious dentists, Max5 and Max10 Treatment Kits are an excellent, high-quality option for creating a profitable teeth whitening practice. Each BEYOND Max5 Kit contains: Each BEYOND Max10 Kit contains: Dual-barrel syringes of BEYOND Advanced Dual-barrel syringes of BEYOND Advanced 5 Formula Whitening Gel (3g/2.5mL) with mixing tips* 10 Formula Whitening Gel (3g/2.5mL) with mixing tips* 5 Syringes BEYOND BlueSeal Gingival Protection (2g/1.6mL) with 5 metal and 5 plastic tips 10 Syringes BEYOND BlueSeal Gingival Protection (2g/1.6mL) with 5 metal and 5 plastic tips 5 Face protection cloths 10 Face protection cloths 5 Patient Consent Forms 10 Patient Consent Forms 1 Multilingual Instruction Manual 1 Multilingual Instruction Manual 5 Post-Whitening Care Instruction Cards 10 Post-Whitening Care Instruction Cards Each BEYOND Max5 and Max10 kits contain five and ten syringes of BEYOND II Advanced Formula Whitening Gel (3g/2.5mL), respectively. Also included with each kit are syringes of BEYOND BlueSeal Gingival Protection for use with each patient, patient consent forms, face protection cloths, a multilingual instruction manual, and post-whitening care cards. *BEYOND Max5 and Max10 kits must be refrigerated near 5 C during storage. BEYOND BOOST PRE-TREATMENT, EXTRA-STRENGTH WHITENING PASTE BEYOND Boost is our newest whitening kit option and is designed for use as a pre-treatment, boost to jump-start the whitening process on patients with severe stains. Each BEYOND Boost Kit contains: 1 Bottle of 35% H 2 O 2 liquid (2mL) 1 Jar of catalyst powder (0.7g) 1 Application brush (for manual mix formula) 1 Plastic spatula for mixing 1 Multilingual Instruction Manual Containing a powerful, 35% hydrogen peroxide manual-mix whitening paste, BEYOND Boost is formulated to reduce the appearance of difficult and severe stains. It is an effective pretreatment whitening boost for tetracycline and fluoride stains and can be used with any BEYOND Whitening Kit. POWERFUL, EFFECTIVE WHITENING GEL IN A PROPRIETARY FORMULA BEYOND II Advanced Formula Whitening Gel contains 35% hydrogen peroxide as the active ingredient. Hydrogen peroxide is the most widely-used active ingredient for professional, in-office teeth whitening and can commonly be found in strengths from 15% to 30%. The 35% BEYOND formula is the most powerful whitening gel on the market designed specifically for light accelerated whitening treatments. Other formulations used in impression tray systems or sold over the counter typically use carbamide (urea peroxide). As carbamide is a combination of hydrogen peroxide and urea, it is weaker, breaks down more slowly, and whitens more slowly. A high-concentration, highly-effective whitening gel ensures the best whitening results in the shortest possible treatment time.

7 BEYOND whitening gel contains proprietary ingredients that leave teeth shiny and white. With BEYOND, results are always glossy-white, never chalky as is common with many inferior whitening materials. POWER WHITENING BALANCING TREATMENT TIME, SAFETY, AND COMFORT In recent years, light accelerated power whitening has become an industry standard for dental professionals. Compared to other teeth whitening methods such as laser whitening and custom impression tray whitening, light accelerated power whitening produces superior results in a shorter amount of time and at a lower individual cost to the dentist. Treatment times vary by system and range from just 30 minutes with the BEYOND Whitening Accelerator and BEYOND Whitening Kits to as long as one and a half hours with other systems. Most common treatment times are about one hour which accounts for patient preparation, three 15-minute consecutive cycles, and clean-up. However there are still a number of problems associated with power whitening, in particular the emission of potentially harmful levels of ultraviolet light and heat from the highintensity light sources. This means that the patient is exposed to potentially dangerous levels of ultraviolet light and heat, increasing their risk of being sunburned in the mouth, developing severe tooth sensitivity, and experiencing damage to their tooth pulp. The BEYOND Whitening Accelerator addresses this problem by filtering out all harmful levels of ultraviolet light and heat. The patient s safety and comfort levels are dramatically increased and the dentist enjoys a simpler procedure and shorter patient preparation times. Other power whitening systems with such intense light sources try to mitigate the aforementioned risks by isolating not only the gum tissue (which must always be isolated from the whitening gel/paste) but also the sensitive pink tissues that are exposed to the light source. This complete isolation can prevent the exposure of harmful UV light, but fails to address the temperature problem, and adding isolation material to the oral cavity can itself increase the buildup of heat in the mouth further increasing the likelihood of severe post-treatment sensitivity. Another serious problem with some other whitening systems is the dramatic dehydration of the enamel during the treatment which can lead to much more serious sensitivity and a chalk-white tooth surface finish. Some other systems may use lower strength gels to reduce sensitivity, or lower strength light sources such as light emitting diodes (LEDs). While a reduction in the strength of the whitening agent can reduce sensitivity, results too are also reduced. Weaker light sources simply do not offer genuine powerwhitening acceleration. When using LED systems or weak whitening gels, time is usually extended (often up to two hours) in order to achieve an acceptable result, but again sensitivity becomes a problem as longer treatment times allow for the gel to travel too deeply into the teeth. Longer treatment times also add to the general discomfort of the patient. The BEYOND Whitening Accelerator is simply the only system that can ensure a shorter treatment time with very strong, consistent results, safety, and little or no post-treatment sensitivity. It is the only system that combines very intense light output and the strongest light-accelerated whitening gel (35% hydrogen peroxide in a proprietary formula) with innovative light filtration system.

8 The BEYOND system is unmatched in consistent, comfortable results in one, 30-minute treatment. SCIENCE BEHIND LIGHT-ACCELERATED WHITENING While it is well known that hydrogen peroxide alone can whiten teeth, the addition of light radiation can significantly increase the breakdown of the hydrogen peroxide and produce better results in a much shorter time. Studies have been conducted over many years to determine the efficacy of power whitening and to identify the risks associated with such treatments. One such study published by the American Dental Association proved peroxide and light treatment significantly lightened the color of teeth to a greater extent than did peroxide or light alone. 2 Not only do such studies highlight the efficacy of light accelerated bleaching over other methods when time is a factor, but such studies provide theory and explanation of the whitening process when light is used in conjunction with a peroxide based whitening agent. The low molecular weight of hydrogen peroxide allows the chemical to easily penetrate the surface of the enamel and travel into the teeth. As the hydrogen peroxide breaks down on the surface and deep inside the teeth, the oxygen released comes in contact with long-chain carbon based molecules which appear as stains. Breaking the molecules into shorter chains, the oxidation renders the stains neutral in color - the whitening that the patient is seeking. The use of a whitening lamp increases the oxidation by introduction of light radiation to the hydrogen peroxide traveling inside the teeth. Such acceleration of the oxidation process shortens treatment time as more hydrogen peroxide can be broken down and more oxygen released in each treatment. Some risks noted in studies include exposure to UV light to surrounding tissues, excessive heat as a risk to tooth pulp, and increases in patient sensitivity. When choosing a power whitening system, it is recommended that the dentists consider carefully a system that produces little or no heat, and allows for treatment times to be monitored and adjusted according to each patient s individual tooth situation. With this in mind, light accelerated teeth whitening is both safe and very effective. THE BEYOND WHITENING TREATMENT The BEYOND Whitening Accelerator is designed for use with BEYOND Whitening kits. Whitening kits are available in a variety of configurations based on the nature of the teeth stains and dentists preference as detailed above. Regardless of the BEYOND kit used in the treatment, the whitening treatment with the BEYOND system will ensure a glossy-white result. The simple treatment ensures each patient is not only happy with his or her results, but satisfied with the entire process having experienced a comfortable, relaxing treatment. Each BEYOND Whitening Kit contains a multilingual instruction manual detailing the treatment procedure. Illustrations and photographs mark each step and highlight points to follow for optimal results. A region-specific instructional DVD is also included with the BEYOND Power Whitening System containing a complete BEYOND power whitening procedure from start to finish including key points to remember. BEYOND also provides free, live, web-based training to all BEYOND agents and dental professionals. 2 JADA, Vol. 134, February 2003, pg American Dental Association

9 SIMPLE TREATMENT PROCEDURE Each BEYOND treatment begins with an examination to determine the nature of the stains, any preexisting conditions that may need to be addressed prior to the treatment, and pre-treatment shade matching with a common shade guide. The patient is then informed of the results they may expect, given some simple instructions to follow during and after the treatment, and told to RELAX and enjoy the treatment. The first step is pre-whitening preparation, including use of cheek retractor, gingival isolation, and drying of the teeth to be whitened. Unlike similar products, there is no need to isolate any additional tissues inside the oral cavity as there is no risk of exposure to harmful UV light. This pre-treatment process, once practiced by the dental professional should take no longer than 10 minutes to complete. Following the preparation, the first of three applications of whitening gel and light acceleration is commenced. 3 Using the dual-barrel syringe of BEYOND whitening gel provided in all BEYOND whitening kit configurations, the dental professional simply applies the gel to the tooth surface of 16 to 20 of the upper and lower front, smile teeth. Between each of the three cycles, dry suction is used to remove the gel, and the gel reapplied. During each cycle, the BEYOND Whitening Accelerator is employed, placed facing the teeth for 8 to 10 minutes in each of the three cycles. As the whitening accelerator dramatically increases the speed of the whitening process, there is no need for cycles to be extended to 15 or 20 minutes as is common with other systems. In 24 to 30 minutes, the entire whitening process is complete. Following the last of the three cycles, the gel is removed with dry suction, the gingival barrier and cheek retractor are removed, and the patient rinses. The dental professional can now show the patient his or her new tooth shade using the shade guide. The improvement is compared against the original shade typically greater than 8 shades and the patient is given a post-treatment instruction card as a reminder to avoid strongly colored foods and drinks for 24 hours following the treatment. The simple preparation, shorter treatment time, and quick, easy clean-up can typically be completed in just 45 minutes from start to finish. This is 50% shorter than similar products saving valuable chair time and ensuring the most comfortable treatment for the patient. There is no other system that is capable of such dramatic whitening results in such a short time. Dental professionals also enjoy the simple treatment procedure incomparable to other systems. SALES CHANNELS - BEYOND GLOBAL OFFICES AND DISTRIBUTION NETWORK BEYOND owns and manages a U.S. corporate headquarters in Stafford, Texas, a European Headquarters in Berlin, Germany, and an Asia Pacific Headquarters in Beijing, China. In all countries with the exception of Germany and China, BEYOND has partner agents who market the BEYOND Whitening Accelerator 3 Treatment procedure using the BEYOND II Complete Kit for Tetracycline and Severe Stains varies slightly from this description.

10 and other BEYOND products to dental professionals. In Germany, BEYOND staffs its own sales force, and in Mainland China, BEYOND is matching the country s growth by opening regional, wholly owned offices across the country. In the more than 90 countries worldwide where the BEYOND Whitening Accelerator is sold, BEYOND enjoys the number one or number two position in most or all of these countries. BEYOND has long been recognized as a global leader in the aesthetic dental community in North America, Europe, and Asia, and more recently in the South American markets and in the Middle East and Africa. With the continued increase in demand for teeth whitening treatments, BEYOND enjoys tremendous growth, providing whitening systems to discerning dentists every day around the world. MANUFACTURING AND QUALITY STANDARDS The BEYOND Whitening Accelerator is manufactured to international quality standards and backed by a full three year warranty. BEYOND products are designed by our own product engineers and chemists, and materials are sourced from a number of global suppliers from countries including the United States, Germany, Switzerland, Japan, Korea, and Taiwan. All suppliers of BEYOND product parts must meet international quality system standards to qualify as a BEYOND parts supplier. Such suppliers include internationally recognized raw materials manufacturers, chemical laboratories, fiber optic product suppliers, and integrate circuit and digital display manufacturers. The BEYOND production and assembly facility is wholly owned and operated and is under direct management and control of BEYOND Technology Corp. The facility assembles and packages all BEYOND Dental & Heath brand products sold worldwide through our company s three headquarter offices and through BEYOND agents in more than 90 countries. The BEYOND production and assembly facility has received ISO 9001 and ISO quality system certification. ISO certification is maintained through annual, independent audits by a German Notify Body. ISO is a prerequisite to CE Class II medical products for sales to European Union countries. CE and ISO classification is also required for product registration by many ministries of health in countries outside the EU. The BEYOND Whitening Accelerator has also been listed with the U.S. Food and Drug Administration Center for Devices and Radiological Health. The product registrations and listing numbers can be viewed on the FDA CDRH site. As a manufacturer of medical devices registered with the U.S. FDA, BEYOND is subject to periodic inspections by the FDA. In addition to registration of our facility and products, BEYOND is also registered with the FDA CDER as a drug manufacturer. To continue to meet and exceed international quality standards, BEYOND employs an experienced team of quality control specialists who directly monitor manufacturing processes, maintain ISO related technical files, and determine appropriate areas for improvements. We are confident in our quality standards for all BEYOND products and extend a three year warranty on all BEYOND electronics and equipment without exception. All consumables are guaranteed through the expiry dates 18 months after manufacture date. CLINICAL TRIALS, STUDIES, AND PRODUCT REVIEWS BEYOND products have been covered in many clinical trials and product reviews around the world over the years. The BEYOND Whitening Accelerator has been proven through numerous clinical studies to

11 be both safe and effective. Studies have included efficacy rates, enamel microhardness, post-treatment hypersensitivity, and effect on tooth pulp. In addition to clinical studies, many BEYOND products, including the BEYOND Whitening Accelerator, have been tested and reviewed by dental publications, universities, and dental researchers. Such reviews have focused on product safety, efficacy, and sensitivity. The BEYOND Whitening Accelerator or other BEYOND products can be seen in product reviews from leading dental publications nearly every month around the world. Such publications include Dental Tribune International, Dentisty (UK), Asia Pacific Dental Notice, The Dental Advisor (US), America Latina Noticias Dentales, Irish Dentist, Private Dentistry (UK), and Dental Products Report (US). Most recently, The BEYOND Whitening Accelerator and BEYOND II Complete Single Patient Kit received a 4 ½ of 5 star review from The Dental Advisor, a leading U.S. independent dental products review association. For inquiries related to the BEYOND Whitening Kits, or to inquire about becoming a BEYOND products agent, please contact the BEYOND Headquarters office nearest you. We value your interest and look forward to hearing from you! BEYOND USA Headquarters Exchange Dr. Suite 558 Stafford, TX USA TEL FAX beyondusa@beyonddent.com BEYOND Asia Pacific Headquarters No.69 Bei Chen West Rd. Suite D 2008/11, Beijing PRC TEL FAX info@beyonddent.com BEYOND Europe Headquarters Jägerstr Berlin, Germany TEL FAX europe@beyonddent.com