parkell Predicta Bulk Dual-Cure Composite Instruction Manual

parkell Predicta Bulk Dual-Cure Composite

Explanation of Symbols Used

• Professional use only
• Follow instructions for use
• Temperature limit
• Keep away from sunlight
• Use-by date (expiration)
• Batch code
• Catalogue / stock number
• Unique Device Identifier
• Medical Device
• Importer
• Package contents
• Do not use if the package is damaged
• Manufacturer
• Single-use only
• Translation
• Dispensing Tips
• 5 ml syringe / paste

Description

Predicta® Bioactive Bulk materials are dual-cured, bulk-fill resin composites, which are easy-to-place and combine excellent strength with exceptional durability, and optical characteristics close to those of natural teeth. Predicta Bioactive Bulk is bioactive and releases calcium and phosphate ions and releases and recharges fluoride ions to stimulate mineral apatite formation and remineralization at the material-tooth interface. Such bioactivity is known in the field to equate to stronger bonds between the restoration and tooth, penetration and filling of micro-gaps, reduction in sensitivity, guarding against secondary caries, and sealing of margins against microleakage and failure. Predicta Bioactive Bulk materials are suitable for direct or indirect restorations. The Bulk material portfolio contains two viscosities to best suit the technique of the user; Bulk-Fill and Bulk-Fill Low-Viscosity (LV). Both versions are highly radiopaque and are light-curable to a depth of 4 mm in 20-40 seconds with a dental curing light emitting blue light at 430- 480 nm, with a minimum intensity of 600 mW/cm2. Both products will self-cure to any depth in approximately 5 minutes at mouth temperature. The materials possess high compressive, tensile, and flexural strength. Their dual-cure capacity makes incremental layering unnecessary.

Indications

• Class I, II, III, IV, and V restorations, including root surface cavities, and post cementation.

Contraindications

• Not for use on or by persons who are sensitive to acrylates, methacrylates, or related monomers or polymers.

Basic Safety Instructions

• Keep out of reach of children.
• For dental use only.
• Avoid contact with skin. In the event of accidental skin contact, wash the affected area immediately with soap and warm water.
• Use a rubber dam, proper intra-oral evacuation, and other suitable isolation methods to prevent contamination of restorations by saliva, blood or other fluids.
• Use of some medicaments (desensitizers, varnishes, liners, products with eugenol) under these materials is not recommended, as they may inhibit resin curing.
• Avoid contamination of products and packages. Do not mix these products with other materials, and do not return dispensed material to its original container. Dispose of, or disinfect, all components that contact patient fluids, following accepted infection control protocols and applicable regulations.
• Consult the online Safety Data Sheet (SDS) at www.parkell.com for advice on safe handling.

Instructions for Use—Direct Restorations

Predicta Bioactive Bulk Restorative may be used for anterior and posterior Class I, Class II, Class III, Class IV or Class V dental restorations, endodontic post cementation, and core build-ups on vital or non-vital teeth. While both Predicta Bulk-Fill and Predicta Bulk-Fill Low-Viscosity (LV) can be used for all direct restorative situations, the Low-Viscosity version may provide better adaptation to the prep walls when restoring primary teeth on pediatric patients when access is limited, or when more flow may be preferable for adaptation to highly irregularly shaped preps. Depending on the preference of the clinician, either material may be dispensed using the included hand syringe plunger, or a 1:1, 5 ml Cartridge Dispensing Gun (hS620), available separately.

1. After caries removal and tooth preparation, rinse the prep with water and dry using oil-free air. Disinfect and de-oil the preparation with appropriate cleansers and solvents.
2. Apply pulpal protection to deep excavation areas on vital teeth, if needed.
3. Prepare the tooth surfaces using an etching technique compatible with your bonding agent (Selective-Etch, Total-Etch or Self-Etch).
4. Apply and fully cure a bonding agent that is compatible with dual-cure resins, such as AmalgamBond® Plus, Brush&Bond®, or Brush&Bond® MAX.
5. Apply the desired matrix or core former and tooth separation device to create a tight contact.
6. Double-bleed the cartridge as follows:
7. Insert the black plunger into the rear of the cartridge, OR, if easier dispensing is desired, insert the cartridge into a 5 ml 1:1 cartridge dispensing gun.
8. Remove the shipping cap but do not discard it as you will be using it later to recap and reseal the cartridge.
9. Bleed a small amount of material onto a pad so it is flowing from both orifices.
10. Affix a brown-base, 1:1 static mixer to the cartridge and bend the integral 17-gauge metal needle tip to the desired angle and apply a protective sleeve or barrier wrap to the cartridge. Express a pea-sized amount of Predicta Bioactive Bulk Restorative through the mixer and onto a pad, and immediately go to the next step.
11. Place the intraoral metal needle tip in the bottom of the prep to be filled, and slowly express the composite as you withdraw the tip, keeping the tip immersed in the material to eliminate air entrapment. Slightly overfill the prep to allow for carving the anatomy later. For more precise application of material, Brown-base, 1:1 static mixers with integral 19-gauge metal needle tips are available separately (30pcs, hS622).
12. To minimize shrinkage stress, allow the material to self-cure for 30 seconds before light curing.
13. Light-cure each surface for 20-40 seconds to a depth of 3-4 mm with the appropriate curing light, to assure shade stability and the hardest possible surface finish. Actual clinical depth of cure depends on factors such as time, light intensity, device condition, the distance between the light and the restoration, resin thickness and material shade.
14. Allow the restoration to “finish” its self-cure to the bottom of the prep at mouth temperature for 5 minutes total elapsed time. This will assure a strong bond between the restoration and the tooth.
15. Remove the matrix band or core former and refine the restoration with rotary abrasive points, wheels and stones. Adjust the occlusion and polish as appropriate.
16. After use removes the mixing tip and discard it. Take the original sealing cap, wipe it to remove any excess material which otherwise might result in possible cross-contamination of the base and catalyst, and place it back onto the cartridge. Once resealed, the cartridge may be cleaned of debris with a damp paper towel and disinfected as detailed below. The cartridge should not be directly sprayed with or soaked in disinfectant.

Tips for Dental Practitioners

The following information should help dental practitioners reduce the risk of cross-contamination between patients when using multiple-use dental dispensers: apply disposable barrier sleeves/wraps over multiple-use dental dispensers before use with each patient; use new, uncontaminated gloves when handling multiple-use dental dispensers; utilize dental assistants to dispense material for the dentist; avoid contact of the reusable parts (e.g., the body of the multiple-use dental dispenser) with the patient’s mouth; do not reuse the multiple-use dental dispenser if it becomes contaminated; do not reprocess a contaminated multiple-use dental dispenser by using chemical wipes or disinfectants; do not immerse multiple-use dental dispensers in a high-level chemical disinfectant, as this may damage the dispenser and the material contained in the device; do not sterilize multiple-use dental dispensers, as this may damage the material contained in the device.

Physical Properties and Working Parameters

• Compressive Strength: 350 Mpa
• Flexural Strength: 130 Mpa
• Barcol Hardness: >=70
• Radiopacity (vs. Aluminum): 280%
• Work Time of Self-cure (25°C): 1-2 min
• Set Time of Self-cure (37°C): 5 min

Storage and Shelf Life

Store in a dry place at 2–25°C (36–77°F). Store tightly sealed, away from direct light. Do not freeze. Use at room temperature. Do not store near eugenol-containing materials. Do not use it after the expiration date.

Kits include

• (1) 5 ml (9.25 g) syringe / paste
• (20) 17-gauge Dispensing Tips (hS621)

Warranty

For full Warranty and Terms of Use information, please visit our website at www.parkell.com. Parkell’s Quality System is certified to ISO 13485. Rx Only—product is intended for use by a licensed dental professional. For Safety Data Sheet (SDS) go to www.parkell.com.

Parkell, Inc.
300 Executive Dr., Edgewood, NY 11717 USA 800-243-7446 • www.parkell.com
UKIP: Topdental (Products) Ltd
12 Ryefield Way, Silsden, W Yorks, BD20 0EF, United Kingdom

References

• Dental Tools, Devices and Materials
• Dental Instruments, Devices and Materials

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