Warnings:
Place lid back on the bottle of EasySoft liner™ adhesive
immediately after use.
R11 – highly flammable
Your permanent denture soft liner solution!
S16 – keep away from sources of ignition
– no smoking
If your goal is to have an excellent result when placing a soft liner each
S23 – do not breath vapour
and EVERY time, then…
Please take the time to read the instructions thoroughly and follow
Precautions:
them exactly .
(an instructional CD is also available)
The possibility of allergic reactions to the product in sensitive persons
cannot be fully excluded.
Indications for use:
Do not leave any soft liner in the mouth that has not attached to the
denture.
EasySoft liner™ can be used indirectly (laboratory processing) or
directly (chairside) for fabricating a permanent soft lining material on
Avoid splattering this material onto clothing as it cannot be removed by
the tissue bearing surface of a denture. EasySoft liner™ is
dry cleaning.
recommended for :
Improved patient comfort !
Certain local anesthetics, retraction solutions, mouth washes or H 2 O 2
may impede the setting reaction.
allowing patient to chew for longer duration with increased
comfort.
Compatibility with other materials
securing dentures with severe undercuts.
relief of a surgical site after placement of dental implants.
Do not contaminate EasySoft liner™ (type “A” silicone) with
compensating for areas of thin mucous membrane which
polyether materials.
vary in resiliency (thin tissue over problem areas, such as
Check bonding of EasySoft liner™ with non-PMMA acrylic
the mandibular nerve)
(e.g. Microwave acrylic). Ensure that non-PMMA acrylic
relief of palatal and/or mandibular tori.
relined with EasySoft liner™ is immersed for curing in
relief of Stafne bone cavities: small mandibular undercuts
50°C/120 F for 2 hours.
located lingual of the first bicuspid to the first premolar.
As with all type A silicones, certain examination gloves may
relief of sharp bony areas on severe atrophic ridges, and
damage the platinum catalyst regardless of whether there is
deep retromylohyoid notches.
direct or indirect contact with the silicone material. This may
extensions of flanges in areas with strong undercuts.
result in EasySoft liner™ not achieving complete setting and
final hardness.
partial denture/ circumferential gaskets around remaining
natural teeth (alternative to a wire clasp, particularly good for
Technical data:
slightly mobile teeth)
Total working time:
2 minutes 15 seconds
post damming of the A-line (post palatal seal)
Intra-oral setting time:
5 minutes
relining of immediate dentures for comfort during the healing
Setting completed:
7 minutes 15 seconds
stage.
Linear dimensional change:
- 0.20 %
a tissue conditioner in cases with chronic denture sores.
Elastic deformation:
99.5 %
Shore-A hardness (24hours): 28
Shelf life:
24 months
Storage temperature:
18 – 23 ºC
(Do not refrigerate)
IMPORTANT !
It is strongly suggested to adhere to the instructions for applying the patented EasySoft liner™ adhesive exactly to ensure optimum bonding to the
denture base material.
The chemical reaction, which occurs during this important step is one of the keys to EasySoft liner™ success.
The first application of adhesive is needed to react with the base material. The adhesive needs 30 seconds to penetrate the acrylic surface.
The second application of adhesive is applied to ensure that a complete layering of the adhesive is on the acrylic base material and permits
optimum bonding of EasySoft liner™ material.
Cartridge delivery system for EasySoft liner ™
It is necessary to use a dispensing gun to push the catalyst and base materials into a cartridge tip for the proper mixed ratio of EasySoft
liner ™ material for optimum result
Dispensing gun Instruction use
1.
Insert the cartridge into the dispensing gun. Ensure that the notches on the cartridge base are pointing downwards. The gun clip will not close if
the cartridge is not properly inserted into the gun.
1
2.
Remove the cartridge lid. Replace lid after use.
3.
Before placing mixing tip onto cartridge, bleed a small amount of EasySoft liner™ until equal amounts of catalyst and base are at the end of
cartridge to ensure equal amounts of catalyst and base will be mixed through the tip.
4.
Mount the mixing tip onto the cartridge of EasySoft liner™ and dispense the required amount of material onto denture base and /or model.
Please note – the colour coded tip for the EasySoft liner ™ should be the same as the colour of the lid. The diameter of auger and length of tip is
crucial to the correct catalyst/base ratio for optimum results.
5. After use, remove and discard used mixing tip and replace lid of cartridge.
Procedural Directory
Laboratory procedures
Using a reline jig
section A –1
New denture with soft liner
Using a flask - one investment procedure
section B -1
Repairing EasySoft liner™
section B -2
Chairside procedures
Chairside
section C -1
Section A – 1
USING A RELINE JIG
step 1
Disinfect the reline impression using manufacturers instructions.
Pour the impression using a high quality dental stone. Type IV stone and vacuum mixed is ideal.
Mount the reline model onto the reline jig as usual.
step 2
Once stone has set, remove denture from reline jig and trim denture for desired thickness of EasySoft liner™ .
EasySoft liner™ requires a minimum thickness of 1mm in order to achieve a proper bonding and curing
Ideal thickness for patient comfort is 2 to 3 mm.
step 3
Once the tissue bearing side and periphery of the denture has been reduced and roughened for adequate EasySoft liner™ thickness , clean the
denture with monomer and place it back onto reline jig.
Separate stone model with a stone to acrylic separator. Allow separator to dry completely.
Please note – cleaning the denture with monomer at this stage is recommended to remove hand oils and debris. However, allow monomer to
completely dry for several minutes before the EasySoft liner™ adhesive is applied!
Brush on EasySoft liner™ adhesive where EasySoft liner™ material is desired, wait 30 seconds
Apply a second coat of adhesive to the areas where EasySoft liner™ material is desired. Allow adhesive to dry for the full 2 minutes – DO NOT
BLOW DRY.
Ensure that the adhesive is applied beyond the prepared periphery. If there is no adhesive there will be no bonding of EasySoft liner™ .
Adhesive must be completely dried prior to applying EasySoft liner™ material.
step 4
Apply EasySoft liner™ material uniformly with a dispensing gun and tip onto the model and the denture base.
Tip ** to prevent air voids being trapped in the EasySoft liner ™ material, keep the end of the tip in the material while dispensing it onto model
and denture.
step 5
Close the reline jig halves and tighten screws to apply pressure as usual.
Place reline jig immediately into pressure pot - immerse in water at 50°C/120°F for a minimum of 35 minutes .**
2
** Dentures which are not made of PMMA acrylic (e.g. microwave material) should be immersed in water at 50°/ 120°F for 2 hours to allow a
proper bonding between base material, adhesive and EasySoft liner ™ .
step 6 Trimming of EasySoft liner ™ and use of sealant
Once the EasySoft liner™ material has cured, remove the denture from reline jig, as usual.
Use sharp scissors to cut excess EasySoft liner™ material at the periphery.
Use a rotary instrument (EasySoft liner™ bur) to create a neat junction between the denture acrylic and the softliner.
Final finishing should be carried out with the EasySoft liner™ polishing discs.
Trimmed areas of acrylic can be polished with pumice, as usual.
Clean EasySoft liner™ thoroughly with soap and water.
Remove any residual acrylic polishing paste prior to using the sealant . If the paste cannot be removed entirely, use the EasySoft liner ™
polishing disc to remove residual paste.
Apply a thin layer of EasySoft liner™ sealant to trimmed areas of EasySoft liner™ only. It is not necessary to apply sealant on the entire soft liner.
It is advisable to place a small amount of EasySoft liner™ sealant into a small dappen dish and apply it with a clean brush.
Once EasySoft liner™ sealant has been dispensed it must be used within 90 seconds.
The sealant loses its adhesive properties after 7 minutes.
Immerse the denture for 30 minutes in 50°C/120°F wa rm water- it is not important to have denture under pressure during this step.
Please note: The silicone sealant does not attain its final mechanical properties until it has
been at mouth temperature for 24 hours .
Section B - 1
New denture with soft liner – one investment procedure
step 1
Be sure when waxing up the new denture for investing, that the required thickness for both the acrylic base and EasySoft liner™ is adequate.
Invest the wax denture in the flask.
When the investment stone is set, boil out and clean the model and investment stone in flask.
Apply separating fluid to the stone and the model (use a separator which forms a microfilm)
Wait until the stone has completely cooled and separator is dry.
step 2
In order to protect the stone model from being damaged during processing of denture base material, apply a thin layer of a flexible silicone
material to protect the entire surface of the model.
Placing the thin flexible silicone material is a very important step. The silicone ensures that the stone model is preserved during the
processing of the acrylic base material. It allows for a second processing technique - EasySoft liner ™ using the same investment of flask .
Once the flexible silicone material is set, close upper and lower flask together to ensure there is no interference.
Trial pack or inject the acrylic into flask as usual.
Process acrylic base material according to manufacturer instruction.
Cool acrylic and flask, as usual.
Open the flask carefully without deflasking.
Discard the silicone spacer.
step 3
It will not be possible to remove the denture from the flask at this stage.
Drill even depth holes using a 2 or 3 mm round bur through the spacer into the entire tissue bearing surface of the denture.
The holes should be the depth of your desired EasySoft liner™ thickness.
The multiple holes will guide you like a ‘dot to dot’ in your trimming of the base material.
Clean denture after trimming from all debris and hand oils.
Brush on EasySoft liner™ adhesive where EasySoft liner™ material is desired, wait 30 seconds
Apply a second coat of adhesive to the areas where EasySoft liner™ material is desired. Allow adhesive to dry for the full 2 minutes – DO NOT
BLOW DRY.
Ensure that the adhesive is applied beyond the prepared periphery. If there is no adhesive there will be no bonding of EasySoft liner™ .
Adhesive must be completely dried prior to applying EasySoft liner™ material.
3
step 4
Apply enough EasySoft liner™ uniformly with a dispensing gun onto the model and the denture base.
DO NOT TRIAL PACK EasySoft liner ™ material
Close the flask and place back into the clamping press as used during base material processing. Apply enough pressure just to keep the 2 flask
halves together tightly during EasySoft liner™ curing.
Immerse the flask and clamp into water bath at 50°C/120°F for a minimum of 35 minutes .**
** Dentures which are not made of PMMA acrylic (e.g. microwave material) should be immersed in 40°-50° C/ 105°-120°F water for 2 hours to
allow a proper bonding between base material – adhesive-EasySoft liner ™ .
See step 6 of A-1 for completion of trimming
Section B - 2
REPAIRING EASYSOFT LINER ™
1.
EasySoft liner™ will adhere to itself without adhesive, providing the existing EasySoft liner™ material is free of debris and hand oils and other
contaminants. DO NOT use adhesive to add EasySoft liner™ to EasySoft liner™ !
New EasySoft liner™ applied to repair the area, requires the same time and adhesive application instructions as required for all EasySoft liner™
applications.
Section C - 1
Chairside - initial placement
clean the denture base thoroughly with water and dry.
reduce the tissue bearing surface enough to allow for the desired thickness of EasySoft liner™ .
EasySoft liner ™ needs a minimum thickness of 1mm in order to achieve a proper bonding and curing.
Apply a coat of EasySoft liner™ adhesive and wait 30 seconds.
Apply a second coat of adhesive and allow it to dry for 2 minutes ( do not blow air dry)
Ensure that the adhesive is applied beyond the prepared periphery.
Adhesive must be completely dried before applying EasySoft liner™ to the tissue bearing surface.
Apply the EasySoft liner™ on to the denture uniformly with a dispensing gun (to prevent air bubbles from being trapped, keep the end of the tip in
the material as you dispense the material)
Insert the denture into the patient's mouth immediately.
The functional excursions (border moulding) should be done.
Intraoral setting time – 5 minutes.
Once the denture has been removed from the patient's mouth, immerse the denture with the soft lining into water at 50°C for at least 15
minutes (no pressure pot is required) or allow 30 minutes for it to cure at room temperature.
Dentures which are not made out of PMMA acrylic (e.g. Microwave) should be immersed in 50°C /120°F wat er for 2 hours to allow a proper
bonding between base material – adhesive- EasySoft liner ™ .
See step 6 in A-1 for trimming instructions
Please note: The silicone sealant does not attain its final mechanical properties until it has been at mouth temperature for 24 hours .
Please advice patient to use a super soft toothbrush in order to clean the soft lined denture.
To ensure excellent soft linings, the total working time and intraoral setting time must be adhered to exactly. Should the temperature of the
material in storage deviate noticeably from 23°C (74°F), the total working and setting times will be a ffected.
4
Material Safety Data Sheet
1.
Identification of the substance/preparation and company
9.
Physical and chemical properties
1.1
Product details:
9.1
Appearance:
Trade name:
Form:
Paste
Colour:
pink
EasySoft liner catalyst paste + Base paste
catalyst paste: pink transparent
Base paste: colourless transparent
EasySoft liner silicone sealant catalyst paste + Base
Odour:
Odourless
paste
9.2
Density: 1.1 – 1.2 g/cm³ at 20ºC
9.3
Solubility in water: Insoluble
1.2
Distributor details:
9.4
pH-value: Neutral
Karlin Dental Distributors Inc
108 Charing Cross
Brantford, ON N3R 2H9
Phone 1-877-922-2622
10.
Stability and reactivity
1-519-720-9424
10.1
Hazardous reactions:
No hazardous reactions
Fax
1-519-754-0638
known.
Email
nancy@easysoftliner.com
sandra@easysoftliner.com
11.
Toxicological information
2.
Composition/information on ingredients
11.1
Acute oral toxicity: LD 50 : > 2000 mg/kg rat.
11.2
Irritant effect on skin:
Non-irritant.
2.1
Chemical characterization:
11.3
Irritant effect on eyes:
Non-irritant.
Hardener paste:
vinylpolysiloxane – filling material –
11.4
Sensitization:
Non-sensitizing.
polymethylhydrogensiloxane
Base paste:
vinylpolysiloxane – filling material –
ppm platinum siloxane complex
12.
Ecological information
2.2
Additional information:
12.1
Environmental precautions: Do not discharge product
No further information since neither hazardous substance
unmonitored into the environment.
nor hazardous compound.
13.
Disposal considerations
3.
Hazards identification
13.1
Product: Disposal in agreement with the Local Waste
No special hazards have to be mentioned.
Disposal Authority.
4.
First aid measures
14.
Transport information
4.1
After contact with skin: No special measures necessary.
14.1
Road transport:
4.2
After contact with eyes: Eye treatment by an Oculist.
GGVS/ADR: No hazardous goods.
4.3
After ingestion: No special measures necessary.
Train GGVE/RID: No hazardous goods.
14.2
Marine transport:
5.
Fire-fighting measures
IMDG/GGVSee-Code: No hazardous goods.
14.3
Air transport:
5.1
Suitable extinguishing media:
Water, foam, CO2,
ICAO/IATA-DGR: No hazardous goods.
dry chemical extinguisher.
15.
Regulatory information
6.
Accidental release measures
15.1
Labelling: The product does not require a hazardous
6.1
Methods for cleaning up/taking up:
Pick up
warning label
mechanically.
16.
Other information
7.
Handling and storage
This information is based on our present state of knowledge. It should
7.1
Handling: No special measures necessary.
not therefore be construed as guaranteeing specific properties of the
7.2
Storage: No special measures necessary.
products described or their suitability for a particular application.
8.
Exposure controls/personal protection
Revised: July 4, 2005
8.1
General protective measures:
No special measures necessary.
5
Material Safety Data Sheet
9.2
Changes in physical state:
1.
Identification of the substance/preparation and company
Boiling point:
< 77ºC
1.1
Product details:
Flash point:
- 4ºC
Trade name:
EasySoft liner Adhesive
Ignition temperature:
460ºC
1.2
Distributor details:
Explosion limit:
2.1 – 11.5 vol. %
Karlin Dental Distributors Inc
Vapour pressure:
97 hPa
108 Charing Cross
Density:
0.9 g/cm³
Brantford, ON N3R 2H9
Solubility in water: insoluble (20ºC)
Phone 1-877-922-2622, 1-519-720-9424
Fax
1-519-754-0638
10.
Stability and reactivity
E-mail
10.1
Hazardous reactions:
Vapours can form an
explosive mixture with air.
2.
Composition/information on ingredients
2.1
Chemical characterization:
11.
Toxicological information
polymethyl methacrylate – copolymer –
11.1
Acute oral toxicity: LD 50 : > 5000 mg/kg rat.
ethyl acetate
11.2
Irritant effect on skin:
Has a degreasing effect on
the skin.
3.
Hazards identification
11.3
Irritant effect on eyes:
Irritations possible.
When used as directed: None
Highly flammable.
12.
Ecological information
Irritating to eyes and skin.
12.1
Environmental precautions: Do not discharge product
unmonitored into the environment.
4.
First aid measures
4.1
After inhalation: Remove the casualty into fresh air and
13.
Disposal considerations
keep calm.
13.1
Product: Dispose remaining material at hazardous or
4.2
After contact with skin: Wash off with soap and water.
special waste collection centres.
Remove contaminated clothing.
13.2
Packaging: Completely emptied packaging can be
4.3
After contact with eyes: Rinse thoroughly with water and
recycled.
contact physician.
4.4
After ingestion: Contact physician immediately. Drink
14.
Transport information
plenty of water.
14.1
Road transport:
GGVS/ADR:
class 3
packing group II
5.
Fire-fighting measures
GGVE/RID:
class 3
packing group II
5.1
Suitable extinguishing media:
14.2
Marine transport:
Extinguishing powder, foam
IMDG/GGV See-Code:
3
EmS:
3-07
packing group II
6.
Accidental release measures
14.3
Air transport:
6.1
Personal precautions:
Ensure adequate ventilation.
ICAO/IATA-DGR: class 3 packing group II
Keep away from sources of ignition, refrain from smoking.
14.4
Further information:
Do not inhale vapours/aerosols.
UN-number:
1173
6.2
Environmental precautions: Do not discharge product
Correct technical name:
ethyl acetate
unmonitored into the environment.
6.3
Methods for cleaning up/taking up: Pick up mechanically.
15.
Regulatory information
7.
Handling and storage
7.1
Handling: Ensure adequate ventilation. Keep away from
sources of ignition, refrain from smoking.
15.1
Hazard symbols:
Highly flammable
7.2
Storage: Keep container tightly closed and store in a dark
15.2
Labelling:
well-ventilated place.
R 11
Highly flammable
S16
Keep away from sources of ignition, refrain from
8.
Exposure controls/personal protection
smoking.
8.1
General protective measures:
Do not inhale
S23
Do not breathe vapour.
vapours. Avoid contact with skin and mucous membranes.
16.
Other information
9.
Physical and chemical properties
This information is based on our present state of knowledge. It should
9.1
Appearance:
not therefore be construed as guaranteeing specific properties of the
Form:
Liquid
products described or their suitability for a particular application.
Colour:
Colourless
Results are furnished to the best of our knowledge, subject to technical
Odour:
Fruit-like
changes within the framework of product development. However,
users must comply with and consider all recommendations and
information in connection with any use
Revised: May, 2005
6