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
Scarica

Caries Detecting Dye