Table of Contents
  • Návod K Použití
  • Instrucciones de Uso
  • Upute Za Uporabu
  • Használati Útmutató
  • Istruzioni Per L'uso
  • Instruções de Utilização
  • Návod Na Použitie

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Essix® PLUS™ Plastic
INSTRUCTIONS FOR USE
INTENDED USE:
Essix® PLUS Plastic is thermoformed to fabricate intra-oral appliances such as retainers, aligners for minor tooth movement, and temporary bridges.
INDICATIONS FOR USE:
Mouthguard and aligner materials are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards,
nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
PERFORMANCE CHARACTERISTICS AND CLINICAL BENEFITS:
Performance characteristics of orthodontic plastics include a good combination of strength, durability and clarity, resistant to cracking or breaking, easily
removeable from models and effortless to trim.
Clinical benefits of orthodontic treatment may include overall improvement of tooth health and correction of malocclusion.
CONTRAINDICATIONS:
This product is contraindicated for patients with a history of allergic reactions to plastics.
WARNINGS:
Excessive heating time during thermoforming will cause plastic to over sag and potential for injury to operator.
Improper thermoforming of the plastic appliance may cause the appliance to crack/break, resulting in sharp edges, loose pieces and possible aspiration of
pieces.
Report serious incidents that have occurred in relation to the device to device manufacturer and the Competent Authority in Member State of residence,
or other applicable regulatory agency.
PRECAUTIONS:
Patients with a history of allergic reactions to plastics should not use this product.
Do not reuse plastic sheet. Once thermoformed it cannot be reused.
Thermoformed device is for Single Patient Use. Risks of reuse include infection and contamination (i.e. bacterial, viral).
Store plastic sheets in a cool, dry place.
Use within one day of opening foil pouch.
ADVERSE REACTIONS:
Allergic reactions.
Improper thermoforming of the plastic appliance may cause the appliance to crack/break, resulting in sharp edges, loose pieces and possible aspiration of
pieces.
STEP BY STEP INSTRUCTIONS:
Thermoforming Instructions (for complete instructions, refer to thermoforming equipment manual):
1.
Essix® PLUS Plastic has a protective film on both sides of the sheet. REMOVE FILM FROM BOTH SIDES BEFORE THERMOFORMING.
2.
All models should be trimmed to ¾" high. Full arch models should have the palate trimmed away.
3.
Spray the model with Trim-Rite® Release Agent to prevent the material from sticking to the model.
4.
Place the plastic into the frame of the machine and the model on the base plate.
5.
Scan/Enter the code per thermo-forming machine used. Swing the heating element over the plastic and press the appropriate start button.
*NOTE: The heating times below should be used as a reference as heating time may vary depending upon machine. If plastic does not adapt to
model, add heating time until adaptation occurs. If plastic "folds" when thermoformed, reduce heating time until material does not fold.
Thickness
Biostar™ Code
0.88mm (.035")
1.0mm (.040")
6.
Move the heating element away from the plastic when the heating and cooling time expires.
7.
Drufomat: hold the element away and press the button on the side to engage the pressure chamber. Biostar: flip the heated plastic over the model.
8.
After the cooling stage, release the pressure per thermo-forming machine used.
9.
Remove the formed tray from the frame of the machine.
10.
Trim and finish the appliance as desired.
SAFE DISPOSAL:
Unused plastic sheets can be recycled.
Used dental appliances may be considered a biohazard. Follow your country-specific laws, directives, standards and guidelines for the disposal of used
devices.
Manufacturer:
Dentsply Sirona Orthodontics Inc.
7290 26th Court East
Sarasota, FL 34243 USA
www.dentsplysirona.com/ifu
Drufomat
133
1:20
143
1:25
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
Maillefer Instruments
Holding Sàrl
Chemin du verger 3
CH-1338 Ballaigues
ENG
MKT-DFU0033-ML Rev. 04
Issued 12-2021
Biostar and Drufomat are not trademarks
of Dentsply Sirona.
©2021 Dentsply Sirona

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Summary of Contents for Essix PLUS Plastic

  • Page 1 INSTRUCTIONS FOR USE INTENDED USE: Essix® PLUS Plastic is thermoformed to fabricate intra-oral appliances such as retainers, aligners for minor tooth movement, and temporary bridges. INDICATIONS FOR USE: Mouthguard and aligner materials are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
  • Page 2: Návod K Použití

    Plastové fólie Essix® PLUS™ NÁVOD K POUŽITÍ ÚČEL POUŽITÍ: Essix® PLUS jsou plastové fólie určené k tepelnému tvarování, které se používají ke zhotovování intraorálních aparátů, např. retainerů a alignerů pro mikropohyby zubů a provizorních můstků. INDIKOVANÉ POUŽITÍ: Materiály na zubní chrániče a alignery se používají ke zhotovování ortodontických a dentálních aparátů, jako alignerů, nákusných destiček, zubních chráničů, nočních chráničů, aparátů...
  • Page 3 Anweisungen zum Tiefziehen (siehe das Handbuch des Tiefziehgeräts zu vollständigen Anweisungen): Der Essix® PLUS-Kunststoff hat auf beiden Seiten der Platte einen Schutzfilm. NEHMEN SIE VOR DEM TIEFZIEHEN DEN FILM VON BEIDEN SEITEN AB. Alle Modelle sollten auf eine Höhe von ¾”getrimmt werden. Vollständige Einkiefermodelle sollten den Gaumen ausgearbeitet haben.
  • Page 4 Essix® PLUS™ Plastik BRUGSANVISNING PÅTÆNKT ANVENDELSE: Essix® PLUS Plastik er termoformet til fremstilling af intraorale apparaturer som f.eks. bøjler, tandskinner med henblik på mindre tandbevægelse og midlertidige broer. INDIKATIONER FOR BRUG: Tandbeskytter- og tandretningsmaterialer er indiceret til fremstilling af ortodontiske og dentale apparaturer som f.eks. tandskinner, bidplaner, mundbeskyttere, natbeskyttere, snorkeapparaturer, bøjler, retentionsbøjler, repositionsskinner, og midlertidige broer.
  • Page 5: Instrucciones De Uso

    INSTRUCCIONES PASO A PASO: Instrucciones de termoformado (para obtener las instrucciones completas, consulte el manual del equipo de termoformado): El plástico Essix® PLUS tiene una película protectora en ambos lados de la lámina. RETIRE LA PELÍCULA DE AMBOS LADOS ANTES DE LA TERMOFORMACIÓN.
  • Page 6 Instructions de thermoformage (pour consulter les instructions dans leur intégralité, veuillez vous reporter au manuel de l’équipement de thermoformage) : Le plastique Essix® PLUS dispose d’un film protecteur sur les deux côtés. RETIRER LE FILM DES DEUX COTES AVANT LE THERMOFORMAGE.
  • Page 7 Οδηγίες θερμικής διαμόρφωσης (για τις πλήρεις οδηγίες, ανατρέξτε στο εγχειρίδιο του εξοπλισμού θερμικής διαμόρφωσης): Το Πλαστικό φύλλο Essix® PLUS διαθέτει μια προστατευτική μεμβράνη και στις δύο πλευρές του φύλλου. ΑΦΑΙΡΕΣΤΕ ΤΗ ΜΕΜΒΡΑΝΗ ΚΑΙ ΑΠΟ ΤΙΣ ΔΥΟ ΠΛΕΥΡΕΣ ΠΡΙΝ ΑΠΟ ΤΗ ΘΕΡΜΙΚΗ ΔΙΑΜΟΡΦΩΣΗ.
  • Page 8: Upute Za Uporabu

    UPUTE ZA UPORABU NAMJENA: Essix® PLUS plastika toplinski se oblikuje za izradu intraoralnih aparata kao što su držači, poravnjivači za manje pomicanje zubi i privremeni mostovi. INDIKACIJE ZA UPORABU: Materijali štitnika za usta i poravnjivača indicirani su za izradu ortodontskih i dentalnih aparata kao što su poravnjivači, poravnjivači zagriza, štitnici za usta, noćni štitnici, aparati za hrkanje, udlage, držači, pozicioneri i privremeni mostovi.
  • Page 9: Használati Útmutató

    Essix® PLUS™ Plastic HASZNÁLATI ÚTMUTATÓ FELHASZNÁLÁS: Az Essix® PLUS Plastic egy hőformált műanyag, amely intraorális eszközök, mint retainerek, kisebb fogmozgások kezelésére alkalmas fogszabályozók és átmeneti hidak előállítására alkalmas. ALKALMAZÁSI TERÜLETEK: Fogvédő és fogszabályozó anyagok alkalmasak ortodontikus és fogászati eszközök, mint fogszabályozók, harapásemelők, fogvédők, éjszakai fogvédők, horkolás elleni eszközök, sínek, retainerek, repozicionáló...
  • Page 10: Istruzioni Per L'uso

    ISTRUZIONI DETTAGLIATE: Istruzioni di termoformatura (per le istruzioni complete, fare riferimento al manuale dell'apparecchiatura di termoformatura): La plastica Essix® PLUS ha una pellicola protettiva su entrambi i lati del foglio. RIMUOVERE LA PELLICOLA DA ENTRAMBI I LATI PRIMA DI TERMOFORMARE.
  • Page 11 STAPSGEWIJZE INSTRUCTIES: Instructies voor thermovormen (raadpleeg de handleiding van de thermovormapparatuur voor de volledige instructies): Essix® PLUS Plastic heeft een beschermende film aan beide zijden van de plaat. VERWIJDER DE FILM VAN BEIDE ZIJDEN VÓÓR HET THERMISCH VORMEN Alle modellen moeten worden bijgesneden tot ¾” hoogte. Van volledig boogvormige modellen met het verhemeltegedeelte worden weggesneden.
  • Page 12 BRUKSANVISNING TILTENKT BRUK: Essix® PLUS plast er termoformet for framstilling av intra-orale apparater som holdere, innrettere for små tannbevegelser, og midlertidige broer. INDIKASJONER FOR BRUK: Munnbeskyttelse og innretter materialer er indikert for framstilling av ortodontiske og dentale apparater som innrettere, bittplater, munnbeskyttelser, nattbeskyttelse, snorkeapparater, splinter, holdere, reposisjonerere og midlertidige broer.
  • Page 13 Instrukcje dotyczące termoformowania (pełne instrukcje znajdują się w instrukcji obsługi urządzenia do termoformowania): Po obu stronach tworzywa Essix® PLUS znajduje się folia ochronna. PRZED TERMOFORMOWANIEM USUNĄĆ FOLIĘ OCHRONNĄ Z OBU STRON. Wszystkie modele powinny zostać przycięte do wysokości ¾”. Modele z pełnym łukiem powinny zostać przycięte w części podniebiennej.
  • Page 14: Instruções De Utilização

    INSTRUÇÕES DE UTILIZAÇÃO PASSO A PASSO: Instruções de termoformação (para obter instruções completas, consulte o manual do equipamento de termoformação): Plástico Essix® PLUS possui uma película protetora em ambos os lados. ANTES DE PROCEDER À TERMOFORMAÇÃO, RETIRE A PELÍCULA DE AMBOS OS LADOS.
  • Page 15 INSTRUCȚIUNI PAS CU PAS PENTRU: Instrucțiuni privind termoformarea (pentru instrucțiuni complete, vă rugăm să consultați manualul echipamentului de termoformare): Materialul plastic Essix® PLUS are o peliculă protectoare pe ambele părți ale foliei. ÎNDEPĂRTAȚI PELICULA DE PE AMBELE PĂRȚI ÎNAINTE DE A TERMOFORMA.
  • Page 16: Návod Na Použitie

    Plast Essix® PLUS™ NÁVOD NA POUŽITIE URČENÉ POUŽITIE: Plast Essix® PLUS je tepelne tvarovaný tak, aby bolo možné použiť ho na výrobu vnútroústných aparátov, ako sú snímateľné strojčeky, priehľadné strojčeky na drobné pohyby zubov a dočasné mostíky. INDIKÁCIE POUŽITIA: Materiály na chrániče zubov a priehľadné strojčeky sú uvedené kvôli výrobe ortodontických a zubných aparátov, ako sú priehľadné strojčeky, vyberateľné...
  • Page 17 Instruktioner för termoformning (för kompletta instruktioner, se bruksanvisningen till termoformningsutrustningen): Essix® PLUS-plasten har en skyddsfilm på båda sidor av arket. TA BORT FILMEN FRÅN BÅDA SIDOR INFÖR TERMOFORMNING. Alla modeller ska trimmas till ¾" höjd. På fullbågesmodeller måste gommen trimmas bort.

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