KULZER 66087339-01 Palabond Permanent Bonding Agent Between Teeth Instructions
- June 1, 2024
- KULZER
Table of Contents
KULZER 66087339-01 Palabond Permanent Bonding Agent Between Teeth
Specifications
- Product Code: 66087339/01
- Booth: 2021-05
- Product Type: Acrylic teeth for full teeth
- Composition: Paladon 65 consists of a powder component in various colors and liquids.
- Main Powder Component: Poly methyl methacrylate
- Main Liquid Components: Methyl methacrylate, methacrylate
- Cadmium- free
- Contains benzoyl peroxide
Instructions for use
Instructions for use Paladon® 65
- Medical Device – for use by dental health care professionals only.
Intended purpose
This dental material is suitable for patients requiring dental treatment for
the following
indications with consideration of the contraindications. For pregnant and
nursing women, the treatment risks must be weighed carefully against the
benefits taking into consideration the unborn child or infant.
Kulzer medical devices ensure the rehabilitation of oral functions such as
chewing, speaking, and aesthetics. They stabilize the remaining dentition
and/or the alveolar ridge restoratively or prosthetically.
Product Description
Denture acrylic for full dentures, heat-curing acrylic.
Paladin 65 consists of a powder component in a range of colors (pink, pink
veined, R50 veined, clear) and liquid.
For use in pack and press technique, and also injection technique for fixed
and removable dentures.
Composition
- Main powder component:
- Poly methyl methacrylate
- Main liquid components:
- Methyl methacrylate, methacrylate
- Paladon 65 is cadmium-free.
- Contains benzoyl peroxide.
Process and indications
- Pack and press technique:
- partial dentures
- full dentures
Contraindications
Direct linking with Paladon 65 is contraindicated. The use of this product is
contraindicated in case of known or suspected allergies against components of
this product. Do not use in case of known or suspected allergy against (meth)
acrylate compounds or benzoyl peroxide.
Side effects
This product or one of its components may in particular cases cause
hypersensitive reactions. If suspected, information on the ingredients can be
obtained from the manufacturer. Hypersensitivity reactions (allergies), local
sensory disturbances, taste disturbances, and irritation of the oral mucosa
have been described in isolated cases. After processing, all MMA/PMMA-based
denture materials always contain a per-mitted, small proportion of residual
monomer (< 4,5 %). For further risk reduction of intolerance reactions, the
denture has to be stored in tepid water for at least 12 hours before
placement.
Handling
A hard stone (type 3) is sufficient for investment of the prosthesis set up in
wax. After wax elimination with boiling water, the plaster is thinly isolated
with Aislar® twice (see Aislar Instruc-tions for Use). To improve the bond
between Paladin 65 and the prefabricated teeth, the basal surfaces are
roughened with a coarse diamond bur (remove grinding dust) and wetted with
Palabond®. Apply Palabond® twice using a brush (without metal ferrule) and
allow to set for 30 seconds each time. After the second application; the
adhesive remains active for 10 minutes.
Amounts required Pack and press technique
- The recommended ratio of powder to liquid is 10 g: 4 ml or a multiple thereof. Place the required volume of liquid in the stirring beaker and, holding at an angle and simultaneously rotating and tapping the stirring beaker, rapidly sprinkle the powder into the
- liquid. Mix thoroughly for about 30 seconds and leave to set for about 15 minutes in the covered stirring beaker. The material has reached its optimum consistency when it can easily be removed from the wall of the stirring beaker and is no longer sticky.
- A setting time of about 15 minutes at about 23°C (73°F) and about 30 minutes for processing is standard.
- Place the dough with excess in the cuvette, slowly close under a press at intervals, and leave under pressure for about 10 minutes. If pieces are thick, add small amounts of dough. The cuvette temperature should be between room temperature and 45°C (131°F).
Polymerization
Paladin 65 can be processed by the short-term method, the Kulzer water bath method, or the long-term polymerization method. Kulzer water bath polymerization is recommended. Pressure is always required via the flask handle to keep the prosthesis free of bubbles. In addition, the pressure of the polymerization device can be switched on.
Rapid boiling method
- With this method, it is a requirement to keep the flask for 15 minutes at 80°C (176°F).
- First place the flask in 90°C (194°F) warm water and leave for at least 20 minutes at 90°C
- (194°F), then let the flask cool down slowly on the handle. Place thick dentures also in 90°C (194°F) warm water. Shut off the heat source and wait for 20 minutes, then 20 minutes at 90°C
- (194°F) afterwards, leave to cool slowly in the water bath.
Kulzer hot water curing unit
Place the cuvette in at least three liters of hot water at 70°C (158°F) with
the cuvette completely covered with water. Maintain this tem-perature for 90
minutes, then bring the water bath to a boil and maintain it at boiling point
for at least 30 minutes. Allow to cool down slowly in the water bath!
Long-term water bath
Place flasks in cold water and polymerize at 90°C (194°F) for 10 hours. Cool
down slowly in the water bath.
Trimming and polishing
After cooling and re-occlusion the prosthesis is carefully removed from the
model and trimmed with cross-toothed cutters.
Before polishing with pumice, the prosthesis is smoothed with sandpaper of
decreasing grit size.
Repair
The heat-curing Pala prosthetic resins from Kulzer can be restored, added to,
and repaired with all cold-curing Pala prosthetic resins.
Storage advice
Do not store above 25°C (77°F). Do not use the material after the expiry date.
Avoid direct exposure to the sun. Reseal carefully after removing product.
General information
- Please, carefully observe the following safety instructions and all processing notes in other sections.
- This product is intended to be used only by this Instructions for Use. Any use of this product is inconsistent with these instructions is at the discretion and sole responsibility of the dental health care professional.
Warnings and safety instructions
May cause skin and eye irritation. Avoid contact with skin. Skin contact may
cause sensitization. Wear suitable protective gloves. In case of contact with
skin, immediately wash with plenty of water and soap. Avoid contact with eyes.
In case of contact with eyes, rinse with water for several minutes. Remove
contact lenses, if present, and easy to do. Continue rinsing. If symptoms
persist, consult an eye specialist. Highly flammable liquid and vapor.
Flashpoint: 10°C. Keep away from heat, hot surfaces, sparks, open flames, and
other ignition sources – no smoking. May cause respiratory irritation. Avoid
breathing dust/fumes/gas/mist/vapors/spray. Toxic to aquatic life with long-
lasting effects.
Application notes
- Examine the integrity of the primary packaging before first use. Damaged products must not be used. When positioning teeth in wax, do not use alcohol-based separating agents (separation of gypsum and wax), as this may cause white discoloration on the basal surface of the prosthesis.
- When giving feedback on the product, please always state batch designation and article number.
- According to the EU Medical Device Regulation users/ patients are obliged to report serious incidents with a medical device to the manufacturer and the competent authority of the country, where the incident occurred.
Disposal information
Recommendation: Dispose of by official regulations. Do not dispose of contents or partially emptied packaging in the household waste or allow them to enter the sewage system. European Waste Catalogue: 180106 Chemicals consisting of or containing hazardous substances.
Safety data sheets and more information are available at our website
www.kulzer.com
® = registered trademark of Kulzer GmbH
Dated: 2 021-05
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Powder
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Liquid
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Medical device
MORE INFORMATION
Manufacturer:
- Kulzer GmbH
- Leipziger Straße 2
- 63450 Hanau (Germany)
- +49 800 4372522
Made in Romania
- Distributed in USA/Canada exclusively by: Kulzer, LLC
- 4315 South Lafayette Blvd.
- South Bend, IN 46614-2517
- 1-800-431-1785
Caution: Federal law restricts this device to sale by or on the order of a dental professional.
FAQ
- Q: Can Paladon 65 be used for direct lining?
- A: Direct lining with Paladon 65 is contraindicated.
- Q: Are there any contraindications for using Paladon 65?
- A: Yes, known or suspected allergies against components of this product, (meth)acrylate compounds, or benzoyl peroxide are contraindications for use.
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>