Opalescence®Quick 45% PF Tooth Whitening System treatment of choice is application of UltraEZ , a potassium nitrate, sticky, viscous gel that may be worn in the Opalescence bleaching tray from 1-2 hours EN First to overnight as needed. Alternative treatments include the following: Description: Opalescence® Quick is a unique in-office bleaching system. It is a clear, highviscosity, sticky, 45% carbamide peroxide gel (pH ~6.5). The fluoride and potassium nitrate in Opalescence Quick 45% PF have been proven to reduce caries susceptibility, lower sensitivity, improve the microhardness of the enamel and improve enamel health. All Opalescence products have unique qualities including sustained release, adhesive properties, and a custom designed application tray. Indications: Opalescence Quick 45% PF is for in office use only. Opalescence Quick 45% PF provides an alternative, more conservative modality of treating dark, discolored teeth (compared to crowns, veneers, etc.) caused by congenital, systemic, metabolic, pharmacological, traumatic, or iatrogenic factors such as dental fluorosis, tetracycline and adult minocycline stains, trauma, erythroblastosis fetalis, jaundice, and porphyria. Because restorative materials will not whiten, we recommend whitening teeth before esthetic restorative placement (wait two weeks after bleaching procedures before placing adhesive restorations). Bleaching problematic teeth to a more natural shade will optimize shade matching. General Information: More attention must be given to tray design because of the sticky, viscous, sustained release features in comparison to early bleaching products! To avoid or reduce irritation, it is advised to limit peroxide contact to tooth surfaces rather than spilling onto soft tissues. If instructions are followed, more predictable results are obtained in days rather than weeks. Results occur more rapidly, which reduces the chronic long-term exposure to peroxide. Our experience has shown that a soft, thin tray material is best (Sof-Tray® 0.035”), since it is more comfortable. With a thin tray, awareness of the tray is minimized, since it occupies less of the patient’s interocclusal space. In addition, scalloping and reservoirs further reduce pressure on the teeth and gums. Pre-Treatment Procedure: 1.Before bleaching treatment, a diagnosis must be performed. Ensure the presence of soft tissue health to minimize tissue trauma. Failed restorations and/ or areas of caries should be restored. Exposed root surfaces may experience sensitivity. If large areas are exposed, or if restorations are inadequate, patients can develop mild to moderately severe pain. Sometimes this can be addressed by simply trimming the tray back, or areas can be covered with a bonding agent. 2.Remove calculus and external stains. If tissue is traumatized, wait one to two weeks before beginning bleaching treatment to minimize possible gingival sensitivity. 3.Wait two weeks following the bleaching procedure before matching and placing resin-bonded restorations because time is required for color stabilization. This is important before placing definitive tooth-colored restorations. 4.Occasionally a slight purple discoloration may appear in the tray following bleaching adjacent to amalgam fillings. This discoloration has proven inconsequential in our years of bleaching experience. 5.When bleaching teeth with large amalgam restorations or cores, the teeth may appear darker. This is because the internal restoration becomes more visible through the bleached enamel. The patient should be made aware that a more extensive esthetic restoration may be required following bleaching. 6.Some teeth do not respond to bleaching, and occasionally the colors return shortly after completion of treatment. This is often the result of a temporary color shift caused by dehydration (and then rehydration) of the teeth. With difficult intrinsic stains, the thicker portions of the tooth usually lighten less (i.e., gingival third lightens less than the body and incisal thirds). 7.When tray is not in service, it should always be stored in an appliance case. Procedure: 1.Fabricate the custom tray using laboratory instructions, or send the working cast/model, and prescription order form (enclosed in kit) to Ultradent. 2. Load tray by expressing one continuous bead of gel approximately half way up (or slightly lower) from the incisal edge on the facial side of the tray from molar to molar. This should use no more than 1/3 to 1/2 of a syringe. 3.Treatment times vary from patient to patient. A session should last no longer than thirty minutes and depends on patient comfort. If used as a starter treatment, only one in-office session is needed. The patient is then sent home with 10%, 15%, 20% or 35% carbamide peroxide Opalescence for prescribed home bleaching regime. Patient should not start home bleaching until 24 hours after in-office treatment. Patients should be evaluated every 5-7 days of home treatment. The clinician may schedule checkups more or less frequently, depending on patients’ needs and degree of progress. The number of days required for complete treatment mainly depends on the type of stains present and their severity. For example, tetracycline stains will require more treatment time than other types of disfiguring stains. 4.Occasionally tooth sensitivity and/or gingival irritation may require treatment. ® a.Patient may wear tray with a near-neutral, sticky, viscous, bland fluoride gel (Flor-Opal®). Daytime use insulates teeth from cold, allowing sensitivity to subside. b.Appropriate administration of mild anti-inflammatory analgesics (e.g., ibuprofen or aspirin). Precautions: 1.Read and understand all instructions. Use recommended tray design and administer appropriate treatment regime to maintain optimal patient comfort. 2.Opalescence Quick 45% PF is NOT a take home bleach. 3.Gingival and general oral health should be good prior to initiating treatment. 4.As a safety precaution, Opalescence should NOT be used during pregnancy. 5.If patient has a known allergy or chemical sensitivity to peroxides, carbopol, glycerin, etc., Opalescence Quick 45% PF is NOT to be used. Mint flavor can be irritating to some patients. If patient has a known sensitivity to mint, do not use. 6.Restorations should be adequately sealed and all exposed sensitive dentin should be covered. If a history of sensitivity exists, treat with appropriate restoration, dentin bonding agent, etc., or temporarily with dentin sealant. 7.Areas of hypocalcification can exist which may not be visible to the naked eye. Hypocalcified areas will whiten faster, thereby becoming more obvious during bleaching. Continue bleaching treatment until the unaffected tooth surface blends. Re-evaluate two weeks after bleaching treatment when tooth color has stabilized. 8.If gingival or tooth discomfort persists (such as excessive temperature sensitivity), inform patient to remove tray, discontinue treatment, and make an appointment to re-treat at another time. Patient may also be sent home with takehome Opalescence bleaching. 9.Maintain control of all Opalescence whitening agents, dispensing only what is needed to reach the next evaluation appointment (approximately 3 to 5 days). Monitor patients’ bleaching progress to prevent bleaching beyond the desired level of whitening or degree of translucency. 10.Understand each patient’s expectations before beginning treatment. Inform patients that existing crowns, tooth colored fillings, etc., do not whiten, even though natural teeth potentially will. 11.All Opalescence whitening agents are supplied in preloaded 1.2ml unit-dose syringes. Material is NOT to be injected. Dispose of syringes when empty. 12.Material should be refrigerated to maintain shelf life. Keep Opalescence Quick 45% PF out of heat and/or direct sunlight. When Opalescence Quick 45% PF is refrigerated, the syringe may take on a frosted appearance. When the syringe warms up to room temperature, it will return to its original appearance. This is normal and does not affect the overall performance of the product. 13.Patients with heavy occlusion or bruxers may require a thicker tray. We recommend 0.60” tray material. Avoid treatment if patient may swallow or aspirate tray. Laboratory Instructions: 1.Pour impression with fast set plaster or dental stone. Alginate must be poured shortly after making impression to ensure accuracy. Trimming is less work if quantity of stone is kept to a minimum. However, have enough mass to ensure removal of model from impression without fracture. Trim base of cast parallel to the occlusal table on model trimmer to within a few millimeters of gingival margin for ease of manipulation. Note palate and tongue areas are removed. Allow model to dry two hours. 2.Ultradent® LC Block-Out quickly provides reservoir spaces in tray. Apply ~0.5mm thickness of material onto desired labial surfaces. Stay about 1.5mm from gingival line. DO NOT extend onto incisal edges and occlusal surfaces. This prevents margin of tray from opening upon biting and/or impinging on soft tissues. Patients may experience less tooth discomfort from tray pressures with reservoirs because of reduced orthodontic pressures. Cure LC Block-Out for approximately 2 minutes (Ultra-Lume®). A hand-held intraoral light can be used (~20-40 seconds per tooth). Wipe off oxygen inhibition layer. 3.With vacuum former (UltraVac or use Econo Vacuum Former), heat tray material until it sags approximately 1 inch. Activate vacuum and adapt softened plastic onto model. Cool and remove model. 4.Cut excess bulk of material away with serrated plastic trimmers (Ultradent® Utility Cutters). 5.With small tactile scissors (Ultra-Trim Scalloping Scissors), carefully and precisely trim tray 0.25 to 0.33mm occlusal from gingival margin. Scallop the gingival embrasures to prevent covering the gingival papillae with the tray. The papillae may become sore and irritated if tray covers them! 6.Return tray to model; check tray extensions. Gently flame polish edges, one quadrant at a time (Blazer Micro Torch). 7.While still warm, hold periphery of each segment firmly against model for three seconds with water-moistened finger. If an area is short of the desired length, gently heat and push the tray material to the desired location. If this over thins the tray material, a new tray should be fabricated. 8.Once tray is fabricated clean with a soft brush and cool tap water. Store tray in appliance case when not in use. EN 1002154.5 1 Keep reservoir below incisal and occlusal surfaces. Reservoirs on facial aspect only. Puddle block-out resin for reservoir approximately 0.5mm deep. EN DE 2 FR NL IT ES PT SV DA 3 FI NO EL RU PL TR KO ZH 4 5 Stay shy of gingiva, scalloping around interdental papilla. Halten Sie sich vom Zahnfleisch fern und arbeiten um die interdentale Papille herum. Restez éloignez de la gencive, festonnez autour des papilles gingivales. Houd afstand tot de gingiva, stulp het uit rond de interdentale papillen. Mentre si esegue la dentellatura intorno alla papilla interdentale, far sì che la mascherina non raggiunga la gengiva. Manténgase lejos de la encía, recortando alrededor de las papilas interdentales. Tenha cuidado com a gengiva ao recortar os rebordos à volta da papila interdental. Undvik tandkött och gör utskärningar runt interdentala papiller. Holdes væk fra gingiva - trim rundt om interdentalpapillerne. Lusikan reuna ei saa ulottua ikenen päälle, minkä vuoksi se pitää pyältää interdentaalisen papillan kohdalta. Hold avstand til tannkjøttet, ved å skjære ut rundt interdentale papiller. Παραμείνετε μακριά από τα ούλα, κόβοντας γύρω από την ενδοδοντική θηλή. Не касайтесь дёсен, вырезав участки вокруг межзубных бугорочков. Nie dotykać dziąseł, poprzez obramowanie wokół brodawki śródzębinowej. İnterdental papillaların etrafında oluk keserek gingivadan uzak durun. 치은(잇몸) 을 띄워두고 치간 유두 주위를 스캘로핑합니다. 远离齿龈,齿间乳头处做弧 线修剪。 Keep reservoir approximately1.5mm from gingiva. Lapping onto gingiva may irritate tissues. Das Abdecken des Zahnfleisches kann zu gereizten Weichteilen führen. Trim tray approximately 0.25 0.33mmshy of gingiva. Le recouvrement de la gencive peut en irriter les tissus. Bij overlapping van de gingiva kan het weefsel gaan irriteren. La sovrapposizione alla gengiva può causare l’irritazione dei tessuti. Scallop around interdental papilla, trimming tray approximately 0.25 to 0.33mm shy of gingiva. Si se monta sobre la encía, puede irritar los tejidos. A sobreposição sobre a gengiva poderá irritar os tecidos. Övertäckning av tandkött kan göra vävnaden irriterad. Kontakt med gingiva kan irritere vævet. Kudokset voivat ärtyä, jos lusikan reunat ulottuvat ikenen päälle. Overlapping til tannkjøttet kan forårsake irritasjon i vevet. Εάν προχωρήστε στα ούλα ενδέχεται να ερεθιστούν οι ιστοί. Нахождение материала на десны может привести к раздражению тканей. Nakładanie na dziąsła może podrażniać tkanki. Gingiva üzerine geçmek dokuları tahriş edebilir. 치은 위를 래핑하면 조직에 자극 이 갈 수 있습니다. 涂抹齿龈可导致软组织疼痛。 TH EN- Do not re-use to avoid cross contamination DE- Nicht wiederholt verwenden, um Kreuzkontamination zu verhindern. FR- Ne pas réutiliser pour éviter la contamination croisée. NL-Niet opnieuw gebruiken om kruisbesmetting te vermijden. IT- Per evitare la contaminazione crociata non riutilizzare. ES- No lo reutilice, así evitará la contaminación cruzada. PT- Não reutilizar para evitar a contaminação cruzada. SV- För undvikande av korskontamination får produkten inte teranvändas. DA- Må ikke genbruges for at undgå krydskontaminering. FI- Älä käytä uudelleen ristikontaminaation välttämiseksi. NO- Skal ikke brukes om igjen, for å unngå smitteoverføring EL- Μην τοεπαναχρησιμοποιείτε για να αποφύγετε τη διασταυρωτική μόλυνση. RU- Повторное использование не допускается во избежание перекрестного заражения PL- Używać jednorazowo dla uniknięcia zanieczyszczenia krzyżowego TR- Çapraz kontaminasyonu önlemek açısından tekrar kullanmayın ARKO- 교차오염을 피하기 위해 재사용하지 마시오 ZH- 请勿重复使用,避免交叉污染 TH- If one or more teeth are much darker than others Teeth of lower esthetic concern need not (e.g., overly dark cuspids), build reservoirs on receive resin. cuspids only to balance end whitening results. EN-Batch code DE- Chargennummer FR- Numéro de lot NL- Batchcode IT- Numero di lotto ES- Código de partida PT- Código do lote SV- Satskod DA- Batchkode FI- Eräkoodi NO- Partikode EL- Κωδικός παρτίδας RU- Номер партии PL- Kod serii TR- Parti kodu KO- 배치 코드 ZH- 批号 TH- EN- Catalog number DE- Katalognummer FR- Numéro de catalogue NL- Catalogusnummer IT- Numero di catalogo ES- Número de catálogo PT- Número de catálogo SV- Katalognummer DA- Katalognummer FI- Luettelonumero NO- Katalognummer EL- Αριθμός καταλόγου RU- Номер по каталогу PL- Numer katalogowy TR- Katalog numarası KO- 카탈로그 번호 ZH- 目录编号 TH- EN- Recycle DE- Recyclen FR- Recycler NL-Recyclen IT- Riciclare ES- Recicle PT- Reciclar SV- Återvinn DA- Genbrug FI- Kierrätykseen NO- Resirkuler EL- Ανακυκλώστε το RU- Утилизировать PL- Poddać recyklingowi TR- Geri dönüştürün KO- 재활용 ZH- 回收使用 TH- EN- Refrigerate DE- Kühlen FR- Réfrigérer NL- In de koelkast bewaren IT- Conservare in frigorifero ES- Refrigerar PT- Refrigerar SV- Kyl ned DA- Opbevares i køleskab FI- Jäähdytettävä. NO- Må holdes avkjølt EL- Το διατηρείτε στο ψυγείο RU- Хранить в холодильнике PL- Przechowywać w chłodziarce TK- Buzdolabında tutun ARKO-냉장하십시오 ZH-冷藏 TH- EN - For Professional use only. DE - Nur für professionelle Anwendungen. FR - Destiné à une utilisation professionnelle uniquement. NL - Uitsluitend voor professioneel gebruik. IT - Solo per uso professionale. ES - Sólo para uso profesional. PT - Destina-se apenas à utilização profissional. SV - Endast för yrkesmässigt bruk. DA Må kun anvendes af tandlægepersonale. DA- Må kun anvendes af tandlægepersonale. FI -Vain ammattikäyttöön. NO - Skal bare brukes av fagfolk. EL - Μόνο για επαγγελματική χρήση. RU - Только для профессионального использования. PL - Tylko do profesjonalnego użycia. TR - Sadece profesyonel kullanım için. AR KO - 전문가용에 한함 ZH - 仅用于专业用途。 TH - EN- Keep products out of heat/sunlight. DE- Produkt nicht in die Sonne legen oder Hitze aussetzen. FR- Gardez les produits loin de la chaleur/de la lumière. NL- Zorg dat het product niet aan hitte/zonlicht wordt blootgesteld. IT- Tenere i prodotti lontano dalle fonti di calore e dalla luce del sole. ES- Mantenga estos productos alejados del calor y de la luz solar. PT- Manter fora do calor/luz solar. SV- Produkterna ska hållas borta från hetta/solljus. DA- Produkterne skal holdes væk fra varme/sollys. FI- Suojaa tuote kuumudelta ja auringonvalolta. NO- Produktene må holdes borte fra varme og sollys. EL- Διατηρήστε τα προϊόντα μακριά από θερμότητα/ηλιόφως. RU- Не подвергайте материалы воздействию тепла/ солнечного света. PL- Trzymaj z dala od źródeł ciepła/światła słonecznego. TR- Ürünleri sıcaktan/güneş ışığından koruyun. ARKO- 제품은 열/햇빛이 들지 않는 장소에 보관합니다. ZH- 产品的保存须避热/避阳光。 TH- Opalescence 45% Flammability 0 Health 6 7 EN- Use by date DE- Verfallsdatum FR- Date de péremption NL- Uiterste gebruiksdatum IT- Utilizzare entro ES- Utilizar antes de PT- Validade SV- Använd före DA- Anvendes inden FI- Viimeinen käyttöajankohta NO- Bruk før dato EL- Ανάλωση έως RU- Использовать до PL- Termin ważności TR- Son kullanma tarihi KO- 소비기한 ZH- 保存期 TH- EN- Irritant DE- Reizmittel FR- Irritant NL- Irriterend IT- Irritante ES- Irritante PT- Irritante SV- Irriterande DA-Irritant FI- Ärsyttävä aine NO-Irriterende stoff EL - Ερεθιστικ RU- Вызывает раздражения PL- Związek podrażniający TK- Tahriş Edici ARKO- 자극성 ZH- 刺激物 TH- For immediate reorder and/or complete descriptions of Ultradent’s product line, refer to Ultradent’s catalog or call Toll Free 1-800-552-5512. Outside U.S. call (801) 572-4200 or visit www. ultradent.com. 1 1 Hazard Rating 4 = Severe Reactivity 3 = Serious 2 = Moderate 1 = Slight 0 = Minimal Up Dental GmbH AM Westhover Berg 30 51149 Cologne Germany Opalescence®Quick 45% PF Tooth Whitening System Manufactured by: Ultradent Products Inc 505 West 10200 South South Jordan, Utah 84095 USA EN- See instructions DE- Siehe Anleitung FR- Voir le mode d’emploi NL- Zie gebruiksaanwijzingen IT- Vedere le istruzioni ES- Vea las Instrucciones PT- Ver instruções SV- Se bruksanvisning DA- Se vejledningen FI- Lue käyttöohjeet NO- Se instruksjonene EL- Δείτε τις οδηγίες RU- Смотрите инструкции PL- Patrz Instrukcja TR- Talimatlara bakınız KO- 지시사항을 확인 하십시오 ZH- 参阅说明 TH- EN- Toxic DE- Giftig FR- Toxique NL- Giftig IT- Tossico ES- Tóxico PT- Tóxico SV- Giftigt DA- Toksisk FI- Myrkyllinen NO- Giftig EL - Τοξικό RU- Токсично PL- Toksyczny TK- Toksik KO- 유독성 ZH- 有毒 TH- Made in USA For product SDS please see our website: www.ultradent.com © Copyright 2012 Ultradent Products, Inc. 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