022807 #23989.3
dose syringe to desired level. lock cap until ready for use. 505 West 10200 South, South Jordan, Utah 84095, USA
Manufactured by: Ultradent Products, Inc.
plunger of IndiSpense and fill unit 3. If not using the preloaded syringe immediately, replace luer
IndiSpense syringe. Slightly depress syringe back into IndiSpense.
syringe is twisted firmly onto the IndiSpense syringe. Do not express contents of unit dose
Figs. 2 & 3 A 1.2ml unit dose U. S. Patent Nos.: 5,697,918; and 5,766,008. U.S. and International Patents Pending.
contamination, a used syringe should not be reattached to the
© Copyright 2003 Ultradent Products, Inc. All Rights Reserved.
at the plunger with the nondominant hand. To prevent cross-
syringe is depressed while the unit dose syringe is stabilized
2. With the palm grasp (Fig. 3) the plunger of the IndiSpense
IndiSpense (see Fig. 2). or visit www.ultradent.com
the unit dose syringe snugly onto the male thread of the Outside U.S. call (801) 572-4200.
large, no-waste, IndiSpense syringe by turning the luer lock of refer to Ultradent’s catalog or call Toll Free 1-800-552-5512.
1. A prelabeled unit dose syringe is attached to the end of the
For immediate reorder and/or complete descriptions of Ultradent’s product line,
B. Using 30ml IndiSpense® System:
conventional manner with thumb on plunger (see Fig. 1).
3. For optimum control, hold syringe in palm of hand rather than in Keep out of reach of children.
for optimum control.
onto syringe:
Fig. 1 Hold plunger in palm of hand U.S. federal law restricts this device to sale by or on the order of a dentist.
2. Twist disposable tip firmly
syringe.
1. Remove luer lock cap from
A. Using 1.2ml prefilled syringes:
Slurry
Pre-Treatment Procedure: MSDS Included
Antibacterial
0 = Minimal
cleaning debris while disinfecting. Chlorhexidine
1 = Slight
to permanent cementation and/or for
2 = Moderate
Reactivity Health
of residual temporary cement prior 1
0
3 = Serious
Consepsis Scrub is used for removal 0
Scrub
4 = Severe
Indications:
Flammability
HAzARD RATINg
Consepsis®
component) chlorhexidine gluconate disinfecting scrub.
Consepsis Scrub
Consepsis® Scrub is a lightly flavored 2.0% (relative to liquid
Description:
The first two numbers are the month, and the third number is the last number of the year.
The letter is a lot number used for manufacturing purposes and the three numbers are the expiration date.
Ultradent syringes have an expiration date stamped on the side of the syringe consisting of one letter and three numbers.
Procedure:
Controlled Product Yes No ?
MATERIAL SAFETY DATA SHEET
1. Before definitive cementation, SECTION I - IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING
Material Manufactured by Ultradent Products, Inc.
Consepsis® Scrub
Name
thoroughly clean preparation with 505 West 10200 South
Material South Jordan, Utah 84095 USA
Disinfecting agent.
Use
Emergency
Consepsis Scrub. We recommend 1-800-552-5512
or 1-801-572-4200 (Outside USA)
Contact
Date EC Representative
September 29, 2003
using ICB® intracoronal bristle Prepared by: Peter Allred
SECTION II - COMPOSITION/INFORMATION ON INGREDIENTS
brushes with Consepsis Scrub for Approximate LD50/LC50
Active Ingredients C.A.S. N.A. or U.N. Numbers
Concentration % Specify Species and Route
cleaning deep grooves on tooth Chlorhexidine Gluconate 2% No toxic effect noted. 18472-51-0
surfaces.
2. Deliver Consepsis Scrub directly to SECTION III - HAZARDS IDENTIFICATION
Fig. 5 Disinfect and clean in one
Fig. 4 Express Consepsis Scrub
Adverse Human May dry out skin.
Effects and Symptoms
operation. Remove all temporary
directly from syringe onto tooth with a
prophy cup from syringe through a
SECTION IV - FIRST AID MEASURES
cement etc., before permanent
White Mac tip or into rubber cup with Eye
Inhalation Flush with lots of water.
N/A
White Mac tip or directly to the Contact
cementation.
or without tip.
Skin Ingestion
Wash with soap and water. If large amounts are swallowed, give 3-4 glasses of water.
Contact
preparation. Note Figs. 4 and 5.
SECTION V - FIRE-FIGHTING MEASURES
Note: If patient is not anesthetized, hold the syringe of Consepsis Scrub under hot tap water for 10 Flammability If Yes, Under
?
Yes No Which Conditions:
Means of Protective Equipment N/A
N/A
seconds to bring the disinfectant closer to body temperature. for Firefighters
Extinction
SECTION VI - ACCIDENTAL RELEASE MEASURES SECTION VII - HANDLING AND STORAGE
3. Cement crown, inlay, etc., onto rinsed preparation following removal of excess water. Take Handling
Personal & Environmental None.
None. Precautions
Precautions
Storage
Methods for
Wipe up with cloth and water. Store at room temperature.
care to prevent salivary contamination before cementation. Cleaning Requirements
SECTION VIII - EXPOSURE CONTROLS/PERSONAL PROTECTION
Respiratory Eye
Protective eyewear.
N/A
Protection Protection
Hand Skin
Latex gloves. Lab coat.
Protection Protection
Treatment Notes:
SECTION IX - PHYSICAL & CHEMICAL PROPERTIES
Melting
Solubility in
Appearance
Light green. Paste. Partial. Not defined.
For composite and amalgam preparations, etc., treat surfaces the same as for temporary crown Point/Range
Water
Other Data
pH
Odor ~6.0
Mint odor. None.
cementation. Place appropriate dentin liner and/or base as needed (we recommend Ultra-Blend® plus?). SECTION X - STABILITY AND REACTIVITY
Chemical Stability Conditions and Hazardous Decomposition Ammonia, hydrogen
N/A
Yes ? No Materials to Avoid Products chloride, oxides of carbon & nitrogen.
SECTION XI - TOXICOLOGICAL INFORMATION
?
Route of Entry ✓Skin Contact Skin Absorption ? Eye Contact Inhalation Acute Inhalation Chronic Ingestion
Precautions: Effects and Symptoms
Eyes: Irritation. Skin: Irritation.
of Short-Term Exposure
Chronic Effects and Symptoms
Tips are disposable; do not reuse.
1. Eyes: Irritation. Skin: Irritation. Ingestion: Irritation.
of Long-Term Exposure
Irritancy
Sensitization N/A Slight.
of Product
Do NOT allow volumes of material to be ingested. Collect extraneous material with proper
2.
SECTION XII - ECOLOGICAL INFORMATION SECTION XIII - DISPOSAL CONSIDERATIONS
Method of
Biodegradability
Yes. In accordance with government regulations.
vacuuming techniques. Waste Disposal
Further Details None.
DO NOT use on patients with known sensitivity to chlorhexidine.
3. SECTION XIV - TRANSPORT INFORMATION SECTION XV - REGULATORY INFORMATION
Not defined.
Not regulated.
Use Ultradent® Syringe Covers sealed with the Ultradent® Impulse Sealer for a protective barrier
4.
SECTION XVI - OTHER INFORMATION
FOR DENTAL USE ONLY. Use as directed.
to prevent cross-contamination. The information and recommendations are taken from sources (raw material MSDS(s) and manufacturer’s knowledge) believed to be accurate;
however, Ultradent Products, Inc., makes no warranty with respect to the accuracy of the information or the suitability of the recommendation
and assumes no liability to any user thereof. Each user should review these recommendations in the specific context of the intended use and
determine whether they are appropriate.
2
h Appliquer le Consepsis Scrub directement Frotter à l’aide de la brossette ICB à faible
nc
Consepsis® Scrub Chlorhexidine Antibacterial Slurry Fre sur la surface dentaire. vitesse afin d’enlever les résidus du ciment
temporaire.
DE-Antibakterielles Chlorhexidin-Poliermittel/F-Pâte anti-bactérienne à base de hlorhéxidine/
NL-antibacteriële chloorhexidinepasta/IT-Pasta antibatterica a base di Clorexidina/ tch Breng Consepsis Scrub direct op het Borstel op lage toeren met een ICB brush om
Du
ES-Pasta Acuosa Antibacteriana de Clorexidina/PT-Pasta Antibacteriana de Clorhexidina/ tandoppervlak aan. restant aan tijdelijk cement te verwijderen.
SV-Klorhexidin antibakteriell pasta/DA-Antobakteriel Chlorhexidin pasta/
FI-Antibakteerinen kloorheksidiini-tahna/EL-Αντιακτηριακ Scrub λωρειδίνης Applicare Consepsis Scrub direttamente Per la rimozione del cemento provvisorio
n
lia
Ita sulla superficie dentaria. sfregare con ICB Brush a bassa velocità.
°F °C
ish Aplique Consepsis Scrub directamente en Fronte con fuerza con el cepillo ICB, a
an
White Mac® Tip la superficie del diente. velocidad baja, para remover los resíduos
Sp
ICB® Brush del cemento temporal.
85° 30°
65° 18°
Utilizar escova ICB a baixa rotãção para
Aplicar Consepsis Scrub directamente na
se
gue remover resíduos de cimento provisório.
superfície dentária.
rtu
Po
Applicera Consepsis Scrub direkt på Skrubba med ICB Brush med lågt varvtal för
ish
ed tandytan. att avlägsna rester av temporärt cement.
Store at room
Sw
temperature
h Applicer Consepsis Scrub direkte på Puds med ICB Brush (eller tilsvarende
nis
Da tandoverfladen. pudsebørste) ved lav hastighed for at
fjerne resterende provisorisk cement.
Scour with ICB Brush at slow speed to
sh Deliver Consepsis Scrub directly to tooth h Applikoi Consepsis-tahna suoraan Pese ICB-harjalla hitailla kierroksilla
gli nis
remove residual temporary cement.
surface.
En Fin hampaan pinnalle. poistaaksesi väliaikaisen sementin jäänteet.
Mit ICB-Brush bei niedriger
an Consepsis Scrub direkt auf die k Τ?θετείστ? Consepsis Scrub Καθαρίστε με ICB Brush με αμηλ?
ee
rm Umdrehungszahl einbürsten, um Reste
zahnoberfläche aufbringen. Gr
Ge κατευθείαν στην επιφάνεια τ? ταύτητ? για να απμακρύνετ? τα
von prov. zementen zu entfernen. δντιύ. υπλείμματ? της πρσωρινή? κνία?.
h Yleiset ohjeet:
General Precautions: n Precauzioni Generali:
ish 1. For Professional use only. nis
lia 1. Prodotto riservato all‘uso professionale.
gl 1. Vain ammattikäyttöön.
Ita Fin
En 2. Prima di iniziare il trattamento vanno esaminate le istruzioni, le precauzioni d’uso ed i 2. Tutustu käyttöohjeisiin, suojaustoimenpiteisiin ja käyttöturvallisuustiedotteeseen
2. Review instructions, precautions, and MSDS before beginning treatment. Use only as directed.
moduli per la sicurezza dei prodotti (MSDS). Utilizzare esclusivamente nei modi indicati.
3. Keep products out of heat/sunlight. ennen toimenpiteen aloittamista. Käytä ainoastaan ohjeiden mukaisesti.
3. Conservare i prodotti al riparo dal calore e dall’esposizione diretta alla luce del sole.
3. Säilytä tuote lämmöltä ja auringonvalolta suojattuna.
4. Avoid skin exposure to resins. 4. Evitare l’esposizione della pelle alle resine.
4. Vältä ihokosketusta resiinin kanssa.
5. Isolate strong chemicals to area of treatment. 5. La presenza di prodotti chimici forti deve essere isolata all’area di trattamento.
5. Eristä käsiteltävä alue vahvoista kemikaaleista.
6. Confirm that patient has no known allergies to treatment materials. 6. Verificare che il paziente non sia allergico ai prodotti scelti per il trattamento.
7. Prima dell’uso intraorale deve essere verificato il flusso del materiale dalla siringa e dalla punta. 6. Varmista, että potilaalla ei ole todettuja allergioita hoitotoimenpiteessä käytettäville
7. Test flow of materials from syringe and tip before using intraorally.
8. Non forzare mai gli stantuffi delle siringhe.
8. Never force syringe plungers. aineille.
9. Usare le guaine Ultradent® Syringe Covers e/o pulire e disinfettare le siringhe dopo 7. Testaa materiaalin juoksevuus ruiskusta ja kärjestä ennen materiaalin käyttöä
9. Use Ultradent® Syringe Covers and/or clean and disinfect syringes between patient.
ciascun paziente.
10. Use standard curing lights with all light polymerized/activated materials. intraoraalisesti.
10. Utilizzare lampade polimerizzatrici convenzionali per tutti i materiali fotopolimerizzabili e
8. Älä käytä liikaa voimaa painaessasi ruiskun mäntää.
fotoattivabili.
9. Käytä Ultradent® ruiskunsuojaa ja/tai puhdista ruisku potilaiden välillä.
n Allgemeine Vorsichtsmaßnahmen:
ma 1. Nur für professionellen zahnmedizinischen gebrauch. 10. Käytä standardisoituja valokovettajia kaikkien valokovetteisten materiaalien kanssa.
Precauciones Generales:
ish 1. Para uso exclusivo de Profesionales.
r
Ge an
2. Lesen Sie die gebrauchsinformationen und Warnhinweise sorgfältig, bevor Sie die
Sp 2. Antes de empezar el tratamiento, revise las instrucciones, precauciones y el MSDS.
Behandlung beginnen. Verwenden Sie die Materialien nur gemäß Vorschrift. k ΓENIKEΣ ΠPOΦYΛΑEIΣ:
Siga las instrucciones.
ee
Gr
3. Schützen Sie die Produkte vor Hitze und direktem Sonnenlicht. 1. Για επαγγελματική ρήσ? μvo.
3. Siempre mantenga los productos alejados del calor y de la luz solar.
4. Vermeiden Sie Hautkontakt mit Kunststoff-Materialien. 4. Evite el contacto de las resinas con la piel. 2. Διαάστ? τις oδηγίες, πρoφυλάει? και MSDS πριν εκινήσετ? τη
5. Aisle los químicos fuertes del área de tratamiento.
5. Beschränken Sie den Einfluß stark wirkender Agenzien auf das Behandlungsgebiet. θεραπεία. Nα τo xρησιμoπoιείτε πάvτoτε σύμφωvα με τις oδηγίες.
6. Asegúrese que el paciente no es alérgico a los materiales.
6. Fragen Sie den Patient nach bekannten Allergien auf die zur Behandlung verwendeten 3. Φυλάτ? τα πρoίvτα απ? την έκθεσή τoυς στo ηλιακ? φως ή σε
7. Antes de usar en la boca, verifique que los materiales fluyan de la jeringa y la punta.
Materialien. θερμτητ?.
8. Nunca empuje con fuerza el émbolo.
7. Prüfen Sie den Fluss des Materials aus der Spritze und durch den Spritzenansatz, 4. Aπoφύγετε την επαφή της ρητίvης με τo δέρμα.
9. Use las cubiertas para jeringas de Ultradent® y/o limpie y desinfecte las jeringas
bevor Sie intraoral applizieren. 5. Περιoρίστε την επαφή των ισυρώv ημικώ? μvo στηv περιoxή της
entre pacientes.
8. Drücken Sie einen Spritzenstempel nie mit gewalt ein. 10. Utilice luces de fotocurado corrientes con todos los materiales activados/polimerizados con luz. θεραπείας.
9. Verwenden Sie Ultradent®-Spritzenhüllen und/oder reinigen und desinfizieren Sie die 6. Nα επιεαιώσετε τ? o ασθενής δεν έxει καμμιά γνωστή αλλεργική
Precauções gerais:
e
Spritzen nach jedem Patienten. αντiδραση στα υλικά της θεραπεiας.
es
gu 1. Somente para uso profissional.
10. Verwenden Sie für Materialien, die durch Licht zu polymerisieren bzw. zu aktivieren 7. Nα δoκιμάσετε τη ρoή των υλικών απ? τη σύριγγα και τo ρύγoς
tu 2. Ler instruções, precauções e MSDS antes de começar o tratamento. Utilizar só como indicado.
r
sind, die üblichen Polymerisationslampen. πριν‑τ? ρησιμoπoιήσετε ενδoστoματικά.
Po 3. Manter os produtos longe do calor e da luz solar directa.
8. Mην πιέετ? πoτέ με δύναμη τo έμλo της σύριγγας.
4. Evitar contacto com a pele.
ch Précautions générales:
9. Να ρησιμoπoιείτε τα πρoστατευτικά καλύμματα συριγγών της
5. Aplicar substâncias químicas fortes só na área de tratamento.
en Ultradent® και vα καθαρίετ? και vα απoλυμαίνετε τiς σύριγγες
6. Confirmar se os pacientes não tem alergías aos materiais utilizados.
1. Exclusivement réservé à l’usage professionnel.
Fr 7. Testar o escoamento dos materiais através da seringa e ponta antes da aplicação intraoral. μετα? των ασθενών.
2. Voir les instructions, les précautions et la notice de sécurité avant le traitement.
8. Nunca forçar os êmbolos da seringa. 10. Nα ρησιμoπoιείτε μια κoινή συσκευή φωτoπoλυμερισμoύ για λ?
Utiliser uniquement selon les instructions.
9. Utilizar protectores de seringa Ultradent® e/ou desinfectar seringas entre cada tratamento. τα φωτoπoλυμεριμενα / φωτoενεργoπoιoύμενα υλικά.
3. Tenir les produits à l’abri de la lumière du soleil et de la chaleur. 10. Utilizar luzes de polimerização standard com todos os materiais fotopolimerizáveis.
4. Eviter le contact des résines avec la peau.
5. Limiter l’application des produits aux seules zones de traitement. Generella försiktighetsåtgärder:
ish 1. Enbart för professionellt bruk. Key: Erklärung der Packungssymbole: Legenda: Merkkien selitykset:
6. S’assurer que le patient ne présente aucune allergie aux produits utilisés lors du traitement.
ed Legende: Legenda: Teckenförklaring: Kλειδί:
Sw
7. Tester le débit des matériaux à travers les seringues et les embouts d’application 2. Läs bruksanvisningar, försiktighetsåtgärder, och varuinformationsblad innan behandling Explication: Clave: Tegnforklaring:
påbörjas. Använd endast enligt anvisning.
avant toute utilisation intra-buccale.
3. Håll produkten borta från värme och solljus.
8. Ne jamais forcer sur le piston des seringues. Catalog Number Destroy after use. Not for injection.
4. Undvik hudkontakt med resiner.
9. Utiliser les couvre-seringues Ultradent® et/ou nettoyer et désinfecter les seringues Bestell-Nr. Nach Gebrauch vernichten. Nicht zur Injektion.
5. Håll behandlingsområdet isolerat från starka kemikalier. Référence du catalogue Détruire après utilisation. Ne pas injecter.
après utilisation. 6. Kontrollera att patienten inte är allergisk mot behandlingsmaterialet. Catalogusnummer Na gebruik vernietigen. Niet injecteren.
10. Utiliser une lampe à photopolymériser standard avec les matériaux photopolymérisables 7. Testa att materialet flyter fritt ur sprutans spets innan användning intraoralt.
REF Numero di catalogo (codice d'ordine) Distruggere dopo l’uso. Non per iniezione.
ou photoactivables. 8. Tvinga ej med “våld? hårt tryck pistongen i sprutan. Número de catálogo Destrúyalo después de usarlo. No debe inyectarse.
Número do catálogo Destruir após usar. Não injectar.
9. Använd Ultradent® sprutskydd och/eller rengör sprutor mellan patienter.
Katalog nummer Förstöres efter användning. Ej för injektion.
10. Använd vanlig ljushärdningslampa till alla ljusaktiverade polymeriseringsmaterial. Katalognr. Destruér efter brug. Ikke til injektion.
Algemene voorzorgsmaatregelen:
tch 1. Uitsluitend bestemd voor aflevering aan en toepassing door tandartsen. Luettelonumero Hävitä käytön jälkeen. Ei injektiokäyttöön.
Du Generelle forholdsregler: Αριθμ? καταλγoυ Καταστρέψτε τo μετά τη ρήσ?. Μη ενέσιμo.
sh 1. Kun til professionelt brug.
ni
2. Raadpleeg gebruiksaanwijzingen en houd rekening met de daarin genoemde
Da 2. Læs vejledningen, forholdsreglerne og sikkerhedsdatabladet før behandlingens start. Bør
aanbevelingen. gebruik alleen zoals is beschreven. Dentist Dispensed.
Keep out of reach of children.
kun anvendes som foreskrevet. Vom Zahnarzt abzugeben.
Außerhalb der Reichweite von
3. Bewaar de producten koel en donker.
Distribué par le Chirurgien-Dentiste.
Kindern aufbewahren.
3. Udsæt ikke produktet for varme og sollys.
4. Vermijd huidcontact met harsen. Door de tandarts verstrekt.
Tenir hors de portée des enfants.
4. Undgå hudkontakt med resiner.
5. Appliceer alleen daar waar nodig. Prescritto dal dentista.
Buiten bereik van kinderen houden.
5. Isoler stærke kemikalier til behandlingsområdet. Administrado por el Dentista.
Tenere fuori dalla portata dei bambini.
6. Overtuig u ervan dat de patiënt niet allergisch is voor de toegepaste materialen. 6. Få bekræftet at patienten ikke har kendte allergier mod de produkter, der anvendes ved behandlingen. Administrado pelo dentista.
Manténgase fuera del alcance de los niños.
7. Test het functioneren van spuitjes alvorens intra-oraal te gebruiken. 7. Check at materialet flyder frit fra sprøjte og spids før brug intraoralt. Appliceras av tandläkare.
Manter fora do alcance das crianças.
Administreret af tandlæge.
Förvaras utom räckhåll för barn.
8. Undlad at bruge voldsom kraft til at tvinge et stempel i funktion. Hvis stemplet ikke
8. Oefen nooit overmatige kracht uit bij de spuitjes.
Hammaslääkärin käyttöön.
Opbevares utilgængelig for børn.
glider uhindret bør årsagen udredes først.
9. gebruik Ultradent® Syringe Covers en/of schone spuitjes bij elke patiënt. Διανέμεται απ? τoν oδoντίατρo.
Pidettävä poissa lasten ulottuvilta.
9. Brug Ultradent® Sprøjteposer og/eller rengør og desinficér sprøjterne efter hver patient.
10. gebruik steeds geteste lichtuithardingsapparaten. Φυλάτ? μακριά τα παιδιά.
10. Brug almindelig polymeriseringslampe til alle lyshærdende materialer.
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