The Caries Detective Caries Detecting Dye Technical Data Dark blue dye in propylene glycol liquid formulation Shelf life: 2 years Store at room temperature Avoid direct heat or sunlight Product Description Snoop is a propylene glycol based caries detector used to assist the dentist in identifying and removing infected carious dentin. Its dark blue color contrasts with dentin and is easily distinguished from the pulp. Researchers have reported that carious dentin is made up of two distinct layers. There is an outer layer of infected carious dentin which is soft, discolored, nonvital, nonsensitive and cannot remineralize. This outer layer is stained by Snoop and should be removed. There is also an inner layer of uninfected carious dentin (also referred to as affected dentin) which is vital and sensitive, not infused with bacteria, and may be somewhat softened and demineralized, but which is capable of remineralizing. This inner layer is not stained by Snoop and should not be removed. Research indicates that the dye in the caries detector bonds to the denatured collagen which is present in the outer infected dentin but which is not present in inner uninfected dentin and normal dentin. Only the outer infected dentin is stained. As a result, Snoop makes it easy to distinguish between outer and inner dentin and enables the dentist to perform a conservative cavity preparation removing only the outer infected dentin. Français SNOOP™ Le détecteur de caries INFORMATIONS TECHNIQUES Teinture bleu foncé de propylène formule de glycole liquide Durée d’utilisation: 2 ans Maintenir à température ambiante Eviter la chaleur directe ou la lumière du jour. DESCRIPTION DU PRODUIT Snoop est un détecteur de caries à base de propylène de glycole qui permet au dentiste d’identifier et retirer la dentine cariée infectée. Sa couleur bleu foncé offre un contraste avec la dentine et se distingue facilement de la pulpe. IMPORTANT • Snoop contient une teinture qui tache. L’utiliser avec précaution. • Appliquer Snoop seulement sur la dent qui doit être teintée et non pas sur les dents adjacentes. • Si Snoop tache des vêtements, une moquette ou des meubles, laver immédiatement avec du savon et de l’eau. • Si Snoop était en contact avec les yeux, laver abondamment à l’eau pendant quinze minutes et contacter un médecin. Warning • Snoop contains dye that stains. Handle with care. • Apply Snoop only to the tooth to be stained and not to adjacent teeth. • If Snoop comes in contact with clothes, carpets or furniture, wash immediately with soap and water. • If Snoop comes in contact with eyes, flush with copious amounts of water for 15 minutes and seek medical attention. • Wear protective eye wear. Use rubber dam. Drape patient with plastic bib. • Keep out of reach of children. Directions for Use 1. Use of rubber dam is recommended. 2. Use Snoop as early in the cavity preparation procedure as possible to avoid removing too much tooth structure. 3.Rinse treatment area with water and dry. 4. Place applicator straw firmly into dropper spout. Using gentle pressure, carefully apply SNOOP directly to the cavity for 10 seconds. 5. Alternatively, hold bottle vertically and dispense a drop of SNOOP into a mixing well. Using a small sponge, brush or paper point, carefully apply SNOOP to the cavity for 10 seconds. 6. After 10 seconds, rinse the cavity with water while applying suction, then dry. 7. Remove the stained dentin using either a low speed handpiece with a round bur or an excavator. 8. Repeat procedure until no staining occurs. • Porter des lunettes de protection. L’utilisation de la digue est recommendée. • Faire porter au patient un tablier en plastique. • Ne pas laisser à la portée des enfants. MODE D’EMPLOI 1. L’utilisation de la digue est recommendée. 2. Utiliser Snoop dans la procédure de préparation de la cavité le plus tôt possible afin d’éviter de retirer trop de la structure de la dent. 3. Rincer la partie traitée avec de l’eau et sècher. 4. Insérer de façon ferme le tube applicateur dans l’orifice du flacon goutte-à-goutte. En pressant légèrement le flacon, appliquer précisemment SNOOP directement dans la cavité de carie. Laisser en place 10 secondes. 5. Alternativement, tenir le flacon verticalement et déposer une goutte de Snoop dans un récipient de mélange. 6. Utiliser une petite éponge ou une minibrush, appliquer soigneusement Snoop dans la cavité pendant dix secondes. 7. Après dix secondes, rincer la cavité avec de l’eau tout en aspirant et sècher. 8. Retirer la dentine teintée en utilisant soit un contre-angle basse vitesse ou un excavateur. 9. Répéter la procèdure jusqu’à ce qu’il n’y ait plus de teinture. 9.2 9.2.1 9.2.2 9.2.3 9.2.4 9.2.5 9.2.6 9.2.7 9.2.8 9.2.9 9.2.10 9.2.11 9.2.12 9.2.13 Important health, safety and environmental information pH Not determined Boiling point Boiling Point: 220°F / 105°C Flash point Not applicable Ignition temperature Not applicable Explosive properties Not applicable Odor threshold Not applicable Vapor pressure Not determined Specific gravity 1.060 Solubility in water Complete Partition coefficient Not determined Viscosity Not determined Vapor density Not determined Evaporation rate Not determined 10.0 Stability and reactivity 10.1 Conditions to avoid 10.2 Materials to avoid 10.3 Hazardous decomposition products 10.4 Further information None. None None None 11.0 Toxicological information 11.1 Acute toxicityNot toxic. Minimal health hazard under normal conditions of use. Irritation and corrosivenessMay cause irritation/redness of eyes, skin or respiratory system. Sensitization Not applicable. Sub-acute, sub-chronic Not toxic and prolonged toxicity Carcinogenicity, Not carcinogenic. No mutagenicity/ reproductive toxicity Mutagenicity, known. Reproductive Toxicity Empirical data None available Clinical experienceSnoop has been sold to and used by dentists all over the world for about 15 years with no reported problems. 11.2 11.3 11.4 11.5 11.6 11.7 12.0 Ecological Information 12.1 EcotoxicityNot toxic. Follow good work practices and government regulations. 13.0 Disposal Considerations 13.1 RegulationsFollow all local and national government regulations in disposing material or contaminated packaging. 14.0 Transport Information 14.1 14.2 14.3 14.4 UN Number Technical name Packing group IATA class Not applicable Not applicable Not applicable Not applicable PULPDENT Corporation 15.0 Regulatory Information 15.1 15.2 15.3 EU US FDA Health Canada 16.0 Other information Class IIA medical device under MDD 93/42/EEC. Class II medical device Class II medical device 16.1 List of relevant R phrasesR36/37/38: Irritating to eyes, skin, and respiratory system. 16.2 Hazard Statements H319: Causes serious eye irritation. Category 2. H335: Specific Target Organ Toxicity (STOT), single exposure, respiratory tract, Category 3: May cause respiratory irritation. H315: Causes skin irritation. Category 2. 16.3 Precautionary Statements P261: Avoid breathing fumes. P280: Wear protective gloves / clothing and eye protection. P304+P340: If inhaled, remove victim to fresh air and keep at rest in a position comfortable for breathing. P305+P351+P338: If in eyes, rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P303+P361+P353: If on skin or hair, remove contaminated clothing. Rinse skin with water. 16.4 Restrictions on usePulpdent dental materials, such as Snoop are to be sold to and used by dental professionals only. 16.5 Further informationThe information presented herein is believed to be factual as it has been derived from the works of persons believed to be qualified experts. However, nothing contained in this information is to be taken as a warranty or representation for which Pulpdent Corporation bears legal responsibility. The user should review any recommendations in the specific context of the intended use to determine whether they are appropriate. 16.6 Sources of key data National Institute for Occupational Safety (NIOSH) US Occupational Safety and Health Administration (OSHA) Eur-Lex European Union Law: Regulation (EC) No. 1272/2008 (CLP) and Regulation (EC) No. 1907/2006 (REACH). Guidance on the compilation of safety data sheets. Version 1.1; December 2011. European Chemicals Agency 16.7 Information which has. This Safety Data Sheet has been revised to meet the been added, deleted requirements of GHS SDS format and Regulations (EC) or revised No. 1272/2008 (CLP) and (EC) No. 1907/2006 (REACH). Specifically Sections 2.1, 2.2, 3.2, 16.2, 16.3 have been modified. XP-SNOOP-IN-16 REV: 06/2014 80 Oakland Street • Watertown, MA 02472 • U.S.A. • (617) 926-6666 or (800) 343-4342 • Fax (617) 926-6262 www.pulpdent.com • [email protected] Español SNOOP™ El Detective De Las Caries Tinte para Detección de Caries DATOS TECNICOS Tinte azul oscuro en una formulación líquida de propilen glicol Vida útil: 2 años Almacenar a temperatura ambiente Evite el sol o el calor directo ADVERTENCIA - Snoop contiene un tinte que mancha. Utilice con cuidado. - Aplique Snoop solamente sobre el diente a ser controlado y no a los dientes adyacentes. - Si Snoop entra en contacto con telas, alfombras o muebles, lave inmediatamente con agua y jabón. - Si Snoop entra en contacto con los ojos, lave con abundante cantidad de agua durante 15 minutos y consulte al médico. - Utilice lentes protectores. Utilice dique de goma. Proteja al paciente con babero plástico. Deutsch SNOOP™ 2 Karies - Detektiv Technische Daten: Dunkelblaues Färbemittel auf Propylen -Glycol Basis Haltbarkeit: 2 Jahre Lagerung bei Raumtemperatur. Direktes Sonnenlicht oder Hitze vermeiden. Vorsicht: • S noop beinhaltet eine Farbe die Flecken macht. Vorsichtig handhaben. • Applizieren Sie Snoop nur auf Zähne die Sie färben wollen und nicht aufbenachbarte Zähne. • Wenn Snoop in Kontakt kommt mit Kleidung, Teppiche oder Möbel, reinigen Sie diese sofort mit Wasser und Seife. • Wenn Snoop mit den Augen in Kontakt kommt spülen Sie mit reichlich Wasser während 15 Minuten und suchen Sie medizinische Hilfe auf. • Tragen Sie eine Schutzbrille. Verwenden Sie Kofferdam. Schützen Sie die Kleidung des Patienten mit einem Plastikumhang. • Außer Reichweite von Kindern aufbewahren. Italiano SNOOP™ il Detective Della Carie Tintura rilevatrice di carie INFORMAZIONI TECNICHE Tintura viola scuro in formula liquida al propilene glicolico Durata del prodotto: 2 anni Conservare a temperatura ambiente Evitare l’esposizione a fonti di calore o ai raggi diretti del sole Descrizione del prodotto Snoop è un rivelatore di carie a base di propilene glicolico impiegato dal dentista per identificare e rimuovere la dentina colpita dalla carie. Il suo colore viola scuro contrasta con la dentina ed è facilmente distinguibile dalla polpa. Le ricerche eseguite hanno dimostrato che la dentina cariata è composta da 2 strati distinti: uno strato esterno infetto, che è morbido, scolorito, non vitale, insensibile, incapace di rimineralizzare. Snoop evidenzia questo strato che dovrebbe venire rimosso. C’è anche un altro strato interno, di dentina non colpita da carie che è vitale, sensibile, non pervasa da batteri, che può essere un po’ morbida e demineralizzata, ma che è ancora in grado di rimineralizzare. Lo strato interno non viene colorato dall’azione di Snoop e non deve essere rimosso. Le ricerche eseguite indicano che il colore dei rivelatori di carie aderiscono al collagene denaturato, presente sullo strato di dentina infetta esterna e che invece è assente nello strato interno di dentina non infetta e di dentina normale. Solo lo strato di dentina esterna infetta viene colorato. Come risultato, Snoop facilita l’individuazione fra dentina esterna e interna, permettendo al dentista di eseguire una preparazione di cavità conservativa del solo strato esterno di dentina infetta. . - Mantenga lejos del alcance de los niños. INSTRUCCIONES DE USO 1. Utilice dique de goma. 2. Utilice Snoop en la preparación lo antes posible para evitar la remoción de demasiada estructura dentaria. 3. Enjuague la zona a ser tratada con agua y seque. 4. Coloque un aplicador descartable firmemente en la punta del gotero. Utilizando presión suave, aplique SNOOP directamente dentro de la cavidad durante 10 segundos. 5. Como alternativa, coloque la botella vertical y dispense una gota de Snoop en un mezclador. 6. Utilizando una torundita o cepillo, aplique Snoop cuidadosamente en la cavidad durante 10 segundos. 7. Después de 10 segundos, enjuague la cavidad con agua mientras aspira y luego seque. 8. Remueva la dentina manchada con una fresa redonda a baja velocidad o con un excavador. 9. Repita el procedimiento hasta que no vea tejido teñido. Pulpdent Corporation Safety Data Sheet 1.0 Commercial Product Name and Supplier 1.1 Commercial product name/ Snoop Caries Detecting Dye designation 1.2 Application / Use Dental material for use by dental professionals. 1.2.2 SIC 851 Human health activity 1.2.3 Use Category 55 1.3 Manufacturer, Importer 1.3.1 Manufacturer Pulpdent Corporation 80 Oakland Street Tel: 1 617 926-6666 P.O. Box 780 Fax: 1 617 926-6262 Watertown, MA 02472 USA Email: [email protected] 1.4 Emergency Telephone Number 1-800-535-5053 (24 Hour / USA) 1.5 Authorized European Representative International Business Solutions Ltd. Tel: 07989 407479 54 Mayfield Ridge, Hatch Warren, Fax: 01256 350330 Basingstoke, RG22 4RS UK Email: [email protected] 2.0 Gebrauchsanweisung: 1. Verwendung von Kofferdam ist empfehlenswert. 2. Verwenden Sie Snoop so früh wie möglich bei der Präparation um nicht zu viel Zahnsubstanz abzutragen. 3. Die präparierten Zähne abspülen und trocknen. 4. Befestigen Sie den Applikator Tip an der Dispenseröffnung. Applizieren Sie nun SNOOP mit sanftem Druck während 10 Sekunden in die Kavität. Oder halten Sie das Fläschchen vertikal und geben Sie einen Tropfen SNOOP in eine Schale und benutzen Sie ein Pellet zur Applikation von SNOOP in der Kavität. 5. Wahlweise, die Flasche senkrecht halten und einen Tropfen Snoop in eine kleine Mischschale geben. 6. V erwenden Sie ein kleines Schaumstoffpellet oder einen Pinsel zum applizieren und lassen Sie Snoop 10 Sekunden in der Kavität. 7. Nach 10 Sekunden spülen Sie die Kavität mit Wasser während Sie absaugen, anschließend trocknen Sie die Kavität. 8. Entfernen Sie verfärbtes Dentin mit einem Winkelstück und Kavitätenbohrer oder mit einem Excavator. 9. Eventuell wiederholen bis sich kein Dentin mehr verfärbt. Avvertenze: • Snoop contiene colore che può macchiare. Utilizzare con cura. • Applicare Snoop solo sul dente che deve essere controllato e non anche sui denti adiacenti. • In caso Snoop venga a contatto con vestiti, tappeti o mobili, lavare immediatamente la parte con acqua e sapone. • S e quantità di prodotto dovessero venire a contatto con gli occhi sciacquare con abbondante acqua per 15 minuti e consultare il medico. • Indossare occhiali di protezione. Applicare la diga di gomma. Proteggere il paziente con appositi telini di plastica • Tenere lontano dalla portata dei bambini Istruzioni D’Uso 1. Si consiglia di applicare la diga di gomma 2. Utilizzare Snoop al più presto nella cavità in modo da eseguire la procedura evitando di rimuovere una quantità eccessiva di struttura dentale. 3. Sciacquare la zona di trattamento con acqua e asciugare. 4. Applicare la cannuccia di applicazione al contagocce. Con una leggera pressione, applicare SNOOP direttamente nella cavità per 10 secondi. 5. Oppure, tenendo il flacone di Snoop in posizione verticale versare una goccia di prodotto nella vaschetta per miscelazione 6. Con una piccola spugna o pennellino, applicare Snoop alla cavità per 10 secondi, facendo molta attenzione . 7. Dopo 10 secondi, sciacquare la cavità con acqua applicando l’aspirasaliva, quindi asciugare. 8. Rimuovere la dentina colorata con una manipolo a bassa velocità con una fresa rotonda o con una curette. 9. Ripetere l’operazione fino a che lo strato di dentina non si macchia più. Revision Date: June 1, 2014 Hazards Identification 2.1Classification 2.1.1 Classification according to Regulation (EC) No. 1272/2008 [CLP] Hazard Class Hazard Category Hazard Statement Eye irritation 2 H319 STOT SE 3 H335 Skin irritation 2 H315 2.1.2 Classification according to Directive 67/548/EEC Irritant (Xi) R36 / 37 / 38 (See SECTION 16 for full text of risk phrases) 2.2 GHS Label Elements Hazard Pictograms Signal Word: WARNING Restricted to use by dental professional only Hazard Statements: H319: Causes serious eye irritation. Category 2. H335: Specific Target Organ Toxicity (STOT), single exposure, respiratory tract, Category 3: May cause respiratory irritation. H315: Causes skin irritation. Category 2. Precautionary Statements: P261: Avoid breathing fumes. P280: Wear protective gloves / clothing and eye protection. P304+P340: If inhaled, remove victim to fresh air and keep at rest in a position comfortable for breathing. P305+P351+P338: If in eyes, rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P303+P361+P353: If on skin or hair, remove contaminated clothing. Rinse skin with water. 3.0 5.0 4.0 First Aid Measures 4.1 General InformationNot hazardous to health or environment. Snoop is a dye that will stain soft tissue and absorbent materials. May cause slight, temporary eye irritation. Corneal injury is unlikely. May cause mild skin or respiratory irritation. Show this safety data sheet to medical personnel. Seek medical attention in case of uncertainty. Eye ContactKeep eyelids apart, flush with running water for 15+ Fire Fighting Measures 5.1 Suitable extinguishing media 5.2 Extinguishing media to avoid 5.3 Special exposure hazards in a fire 5.4 Special protective equipment for fire-fighters Decision should be based on surrounding fire. Decision should be based on surrounding fire. None None 6.0 Accidental Release Measures 6.1 Personal precautions.Material will stain skin and clothing. Wear gloves, lab coat and/or apron and safety glasses. Environmental precautionsNot hazardous to environment. Follow all government regulations. Method for clean upAbsorb or wipe up spill with suitable material (paper towels or disposable cloths). Collect for disposal in a drip-proof plastic bag or container to prevent further staining of surroundings. Wash area of spill promptly with alcohol or soap and water, though discoloration of spill area may persist. 6.2 6.3 7.0 Handling and Storage 7.1 7.3 HandlingMedical device for use only by trained dental professionals. Follow good hygiene practices. Do not smoke, eat or drink while using. Re-cap container immediately to prevent spills. StorageKeep tightly capped in original container. Store at cool room temperature. Avoid extreme temperatures (>27°C/80°F, <5°C/40°F). Shelf life for unopened product is two years from date of manufacture provided that the material has been stored properly. Specific uses Dental material 8.0 Exposure Controls / Personal Protection 7.2 Composition 3.1 Chemical characterization Mixture of propylene glycol, water, colorant and emulsifier 3.2 Hazardous ingredients CAS Name of Concentration Classification Classification per Number the Ingredient per 67/548/EEC Regulation (EC) No.1278/2008 (CLP). 57-55-6 Propylene 49.5% Irritant (Xi) R36 Eye irritation, 2 glycol, USP 7732-18-5Water 49.5% ---- ---------- ------ Colorant < 1.0% Irritant (Xi) Eye irritation, 2 R36 / 37 / 38 STOT SE, 3 Skin irritation, 2 ------- Emulsifier < 5.0 % Irritant (Xi) Eye irritation, 2 R36 / 37 / 38 STOT SE, 3 Skin irritation, 2 4.2 minutes. Remove contact lenses after several minutes. Get medical advice or attention as indicated. Skin ContactRemove contaminated clothing. Immediately wash with soap and running water. Get medical attention for persistent irritation. 4.4 IngestionRinse mouth with water to minimize staining of soft tissue. No emergency medical treatment necessary. 4.5 InhalationMove to fresh air. If necessary, administer oxygen and/ or artificial respiration; seek medical attention. 4.6 Precautions for first Wear safety glasses and gloves. responders 4.7 Information for physicians SymptomsContact with material may cause mild irritation in eyes, respiratory system or on skin. Skin and soft tissue may be stained. Hazards May cause irritation. Treatment Same as above under First Aid 4.3 8.1 8.2 8.2.1 8.2.1.1 8.2.1.2 8.2.1.3 8.2.1.4 Exposure limit values Not established Exposure controls Occupational exposureNo special equipment or ventilation required under controls normal conditions of use in dental practice. Respiratory protectionNo special requirements under normal conditions of use. Hand protection No special requirements other than surgical gloves. Eye protection No special requirements other than safety glasses. Skin protectionNo special requirements other than good hygiene and safety practices to prevent contact with skin and subsequent staining. 8.2.1.5 Other controlsEmergency eye wash fountain should be close by and maintained. Wash hands after use. Do not eat, drink or smoke. 8.2.2 Environmental exposure Follow all government regulations. controls 9.0 Physical and Chemical Properties 9.1 Appearance / Color 9.1.1 Color 9.1.2Odor Very dark blue liquid None