Filtek Bulk Fill Flowable Restorative, is a low viscosity, visible-light activated, radiopaque, flowable. This low stress flowable material is semi translucent enabling a 4 mm depth of cure. The restorative is packaged in capsules and syringes. The shades offered with Filtek Bulk Fill flowable are U (Universal), A1, A2, and A3.
Filtek Bulk Fill flowable contains bisGMA, UDMA, bisEMA(6) and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.1 to 5.0 microns and zirconia/silica with a particle size range of 0.01 to 3.5 µm. The inorganic filler loading is approximately 64.5% by weight (42.5% by volume). Filtek Bulk Fill flowable is applied to the tooth following use of a compatible methacrylate-based dental adhesive, such as manufactured by 3M ESPE, which permanently bonds the restoration to the tooth structure.
• Base under Class I and II direct restorations
• Liner under direct restorative materials
• Pit and fissure sealant
• Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
• Class III and V restorations
• Undercut blockout
• Repair of small enamel defects
• Repair of small defects in esthetic indirect restorations
• Repair of resin and acrylic temporary materials
• As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown
Precautionary Information for Patients
This product contains substances that may cause an allergic reaction by skin contact in certain individuals. Avoid use of this product in patients with known acrylate allergies. If prolonged contact with oral soft tissue occurs, flush with large amounts of water. If allergic reaction occurs, seek medical attention as needed, remove the product if necessary and discontinue future use of the product.
Precautionary Information for Dental Personnel
This product contains substances that may cause an allergic reaction by skin contact in certain individuals. To reduce the risk of allergic response, minimize exposure to these materials. In particular, avoid exposure to uncured product. If skin contact occurs, wash skin with soap and water. Use of protective gloves and a no-touch technique is recommended.
Acrylates may penetrate commonly used gloves. If product contacts glove, remove and discard glove, wash hands immediately with soap and water and then re-glove. If allergic reaction occurs, seek medical attention as needed.
Filtek Bulk Fill – Instructions for Use
1. Prophy: Teeth should be cleaned with pumice and water to remove surface stains.
2. Shade Selection: Prior to isolation of tooth, select the appropriate shade(s) of Filtek Bulk Fill flowable using a standard VITAPAN classical shade guide. For sealants or core build ups, a contrasting shade may be desirable to enhance detection. Note: As Filtek Bulk Fill flowable is semi translucent, the location of the restoration, underlying tooth color or adjacent restorations may influence the final appearance of the liner/base.
3. Isolation: A rubber dam is the preferred method of isolation. Cotton rolls and an evacuator can also be used.
1. Matrix band: Formation of tight proximal contacts is accomplished solely through careful matrix technique. Wedging is needed to provide a tight gingival seal and to create a separation between teeth to compensate for thickness of the matrix band. Where possible, use of a precontoured sectional matrix band is preferred. However, a thin circumferential dead-soft band can be used when appropriate. The band should be burnished to ensure proper proximal contour as Filtek Bulk Fill flowable will not hold the band during placement.
2. Pulp protection: If a pulp exposure has occurred and the situation warrants a direct pulp capping procedure, use a minimum amount of calcium hydroxide on the exposure followed by an application of 3M ESPE Vitrebond or Vitrebond Plus Light Cure Glass Ionomer. Vitrebond or Vitrebond Plus liner/bases may also be used to line areas of deep cavity excavation.
3. Adhesive System: To bond Filtek Bulk Fill flowable to tooth structure, use of a 3M ESPE dental adhesive system (for example 3M ESPE Scotchbond Universal) is recommended. Refer to adhesive system product instructions for full instructions and precautions for the products.
After curing the adhesive, continue to maintain isolation from blood, saliva and other fluids and proceed immediately to placement of Filtek Bulk Fill flowable. Note: Follow the adhesive system instructions for use for recommended silane treatment during repair of ceramic restorations followed by the adhesive application.
4.1. Syringe delivery: Filtek Bulk Fill flowable can be delivered directly from the dispensing tip.
4.1.1. Protective eyewear for patients and staff is recommended when using the dispensing tip.
4.1.2. Prepare the dispensing tip: Remove cap and save. Twist the prebent disposable dispensing tip securely onto the syringe. Holding the tip away from the patient and any dental staff, express a small amount of Filtek Bulk Fill flowable to assure that the delivery system is not plugged.
4.1.3. If plugged, remove the dispensing tip and express a small amount of Filtek Bulk Fill flowable restorative directly from the syringe. Remove any visible plug, if present, from the syringe opening. Replace dispensing tip and again
express composite. Filtek Bulk Fill flowable restorative may be extruded onto a dispensing pad and applied with an appropriate instrument.
4.1.4. Place the functioning syringe with attached delivery tip into a suitably shaped barrier sheath; pierce end of sheath with cannula, exposing the cannula for use. Using a barrier sheath facilitates cleaning and disinfection of the syringe between patients.
4.2. Single-Dose Capsule: Insert capsule into 3M ESPE Restorative Dispenser. Refer to separate restorative dispenser instructions for full instructions and precautions.
5.1. Avoid intense light in the working field. Exposure of paste to intense light may cause premature polymerization.
5.2. Dispense Filtek Bulk Fill flowable: Start dispensing in the deepest portion of the preparation, holding the tip close to the preparation surface. As material is extruded, slowly raise the tip so it is slightly above the dispensed material to minimize air entrapment. Do not allow the tip to be immersed in the material. For proximal areas, hold the tip against the matrix to aid material flow into the proximal box.
5.2.1. Base/liner application: Allow for at least 2 mm on the occlusal cavosurface for the universal or posterior composite. These occlusal increments provide strength, wear resistance and esthetic qualities needed for posterior restorations.
5.2.2. Core buildups: Syringe material into undercut areas, around pins, around posts and fill the preparation.
5.2.3. Sealant applications: Flow material onto the prepared surface.
5.3. Light cure restorative as indicated in Section 6.
6. Curing: This product is intended to be cured by exposure to a halogen or LED light with a minimum intensity of 550 mW/cm2 in the 400-500 nm range. Cure each increment by exposing its entire surface to a high intensity visible light source, such as a 3M ESPE curing light. Hold the light guide tip as close to the restorative as possible during light exposure
7. Complete the restoration:
7.1. Base/Liner application: Place a composite restorative material, such as Filtek Supreme Ultra/Filtek Supreme XTE Universal Restorative directly over the cured Filtek Bulk Fill flowable restorative. Follow the manufacturer’s instructions regarding placement, curing, finishing, occlusal adjustment, and polishing.
7.2. Pit and Fissure Sealants: Gently remove the inhibited layer remaining after light curing with slurry of pumice or polishing paste.
7.3. Core build up:
7.3.1. The bulk fill restorative is compatible with commonly-used impressioning materials when surface inhibition layer is removed.
7.3.2. The bulk fill restorative should be kept wet with saliva or lubricated to prevent bonding to chemical-cure provisionals.
7.3.3. Commonly used temporary luting cements will not bond to the bulk fill restorative.
7.4. Direct Restorative Application:
7.4.1. Contour restoration surfaces with fine finishing diamonds, burs or stones.
7.4.2. Check occlusion with a thin articulating paper. Examine centric and lateral excursion contacts. Carefully adjust occlusion by removing material with a fine polishing diamond or stone.
7.4.3. Polish with 3M ESPE Sof-Lex Finishing and Polishing System or with white stones, rubber points or polishing paste where discs are not suitable.