premier 3001512 CompCore AF Stack Dual Cure Composite Core Built up Material Instructions

CompcCore™ AF Stack
Dual-Cure Composite Core Build-Up Material
Hyperbranched Technology™ • Fluoride releasing • Radiopaque

Instructions For Use

Intended Use:

CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.

Product Description:

Premier® CompCore™ AF is a dual cured, fluoride releasing, radiopaque composite core build-up material for use in vital and non-vital teeth. The device is available in a syringe or a
dual-barrel cartridge.

Contents:

Premier CompCore AF is available in various kit configurations to match the clinical preferences:

3001512
Shade White
3001513
Shade A3
3001514
Shade Blue| SyringeMix STACK:
Dual-Cure/Automix
• 2 – 9g automix syringes
• 15 – mix-tips (Single use)
• 15 – standard intraoral tips
• 10 – extra-fine intraoral tips
3001432
Shade White
3001433
Shade A3| Cartridge Refills
• 1 – 50g cartridge
• 25 – mix-tips
• 25 – intraoral tips
3001418| SyringeMix Mix-Tips & Intraoral Tips (35)
3001468| SyringeMix Extra-Fine Intraoral Tips (50)
3001417| Cartridge Mix-Tips & Intraoral Tips (35)

Materials:

Composite Core Build-Up material formulation is a unique combination of methacrylate resins, and fillers.

Physical Properties

Contraindications:

• Do not use on patients who have a history of known sensitivity or severe allergic reaction to methacrylate resins or any of the components.
• Do not place CompCore AF, if a dry field is not possible.

Precautions:

• Disposable tips are designed for single patient use only. Do not re-use a mix-tip.
• Working & setting times will vary based on temperature, humidity, and product age and storage conditions.
• Use a protective plastic sheath barrier on the syringe to mitigate potential cross-contamination between patients.
• Avoid contamination of product. Do not mix components with those of other materials. Do not return dispensed components to their original container. Dispose of leftover material properly.
• Avoid sunlight or nearby heat sources. Shelf life will be reduced if not stored properly.
• To prevent lack of setting, ensure all eugenol-containing materials are removed prior to placing CompCore AF.
• Ensure material is at room temperature prior to use to prevent longer cure-time.
• Prescription device, Rx only.

WARNINGS:

• For use by a trained dental professional only.
• Do not use after the shelf-life period indicated on product labeling/packaging.
• Large amounts of excess material may generate heat as part of the normal setting reaction.

Adverse Reactions:

Adverse reactions may include but are not limited to:

• Inflammation, irritation, or damage of soft and hard tissue.
• Allergic reactions to CompCore AF material. Wash exposed area completely to remove material. If an allergic reaction is observed, consult a physician immediately and  discontinue use with this patient.
• Pain, discomfort, and/or abnormal sensations due to the presence of CompCore AF.

If a serious incident has occurred in relation to the device, please report the incident to the Manufacturer and/or competent authority of the Member State where the device was used.
Directions for Use (Please follow carefully.)

Core Build-Up Instructions:

1. Apply a bonding agent system, such as Premier’s IntegraBond. Follow manufacturer’s instructions for use with dual-cure composites.
2. Select CompCore AF shade and assemble dispenser (cartridge or syringe). Graphic assembly instructions for both the gun and cartridge unit or syringe are enclosed separately with this package. Bleed cartridge or syringe on initial use and bleed through assembled mix-tip and intraoral tip before each use.
3. Place intraoral tip into the base of the prepared tooth and dispense an adequate amount of material to complete build-up. Let material rise around the tip while withdrawing to eliminate air bubbles. Cure-Thru® matrix bands can be used to confine the material and define the build-up.

Light-Cure Directions:

1. Place the curing-light (Halogen or LED) close to the surface of the core build-up and polymerize for at least 30 seconds.
   If the core has a depth greater than 8mm, a minimum of 40 seconds is recommended.

2. Check for complete hardness. The preparation can be finished immediately with a Two Striper® diamond or other bur.

Chemical-Cure Directions:

1. Do not disturb CompCore AF after the placement or during the gelation stage. Chemical-cure intraoral set-time is approximately 4.5 minutes from start of mix/application. Set time takes longer outside the mouth. Optionally, light-cure for 20 seconds after application to stabilize the core material and to accelerate chemical-cure process.
2. Check for complete hardness. Finish preparation with a Two Striper® diamond or other bur.

Light-cure setting times

Chemical-cure setting times

Storage:

• CompCore AF can be stored in a temperature range 4°C(39°F)- 24°C(75°F).
• Do not store at temperature over 24°C (75°F).
• Do not freeze.

Shelf Life:

• CompCore AF has a shelf life of 2 years (24 months) from the date of manufacturing.
• Do not use after product has expired. See expiry date on the product label.

For Further Information:
To obtain an SDS visit www.premierdentalco.com or call Premier at 610-239-6000.

Symbols:

A full explanation of symbols used on Premier Dental Packaging and literature is located at premierdentalco.com/symbolglossary

order of a physician
| Catalog Number
| Do not use if package is damaged

Premier® Dental Products Company
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A.
888) 670-6100 • 610-239-6000 • premierdentalco.com
Made in Israel.
DFU# 30107 • 0423080 Rev9 BJM

References

• Premier Dental | Symbol Glossary
• Premier Dental | PDC Home

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