ChemFil Rock – restorative is a high strength zinc-reinforced glass ionomer

ChemFil Rock restorative is a high strength zinc-reinforced glass ionomer restorative offering the following features:

  • Resistance to fracture and wear.
  • Marginal seal in dentin and enamel comparable with composites.

ChemFil Rock

    • Self-adhesive to enamel and dentin.
      • Releases fluoride.
      • Packable, non-sticky and sculptable consistency.
      • Bulk placement and self-cure setting.
      • High contrast to tooth substance through high opacity.
      • Effective capsule application with ergonomic applicator.

Available shades: A1, A2, A3, A4, Opaque and Contrast White.

Capsule Extruder 2 is the device designed for extrusion and direct application of ChemFil Rock restorative capsules.

1.1 Delivery forms

  • Predosed mixing capsule for direct intra-oral application with a minimal dispensable amount of 0.1 ml.

1.2 Composition

      • Calcium-aluminum-zinc-fluoro-phosphor-silicate glass
      • Polycarboxylic acid
      • Iron oxide pigments
      • Titanium dioxide pigments
      • Tartaric acid
      • Water

1.3 Indications
Especially designed for:

  • Semi-permanent restorations of Class I and II cavities in posterior teeth.

In addition suitable for:

      • Restoration of deciduous teeth.
      • Restoration of Class V lesions and cavities.
      • Restoration of Class III cavities.
      • Base/core-build-up. When used as a core-build-up, 2/3 of the remaining coronal dentin or at least 2 mm of circumferential coronal dentin should be left for retention.

1.4 Contraindications
• Direct or indirect pulp-capping.
• Use in patients with known allergies to calcium-aluminum-zinc-fluoro-phosphorsilicate glass or any of the other components.

Safety notes
Be aware of the following general safety notes and the special safety notes in other chapters of these Instructions for Use.

Warnings
The mixed ChemFil Rock contains polycarboxylic acid and tartaric acid and may be irritating to skin, eyes and oral mucosa.

      • Avoid eye contact to prevent irritation and possible corneal damage. In case of contact with eyes rinse immediately with plenty of water and seek medical attention.
      • Avoid skin contact to prevent irritation. In case of contact, reddish rashes may be seen on the skin. If contact with skin occurs, immediately remove material with cotton and wash thoroughly with soap and water.
      • Avoid contact with oral soft tissues/mucosa to prevent inflammation. If accidental contact occurs, immediately remove material from the tissues. Flush mucosa with plenty of water after the restoration is completed and expectorate/evacuate the water. If inflammation of mucosa persists, seek medical attention.

Precautions
ChemFil Rock is intended to be used only as specifically outlined in these Instructions for Use.

Any use of this product inconsistent with these Instructions for Use is at the discretion and sole responsibility of the dental practitioner.

      • Use protective eyewear, mask, clothing and gloves for the dental team and protective eyewear for patients.
      • Capsules are intended for single use only. Discard after use. Do not reuse.
      • If material has started to set excessive pressure may result in rupture of the capsule.

Adverse reactions

      • Eye contact: Irritation and possible corneal damage.
      • Skin contact: Irritation or possible allergic response. Reddish rashes may be seen on the skin.
      • Contact with mucous membranes: Inflammation (see Warnings).

Storage conditions
Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.

      • Store in sealed packs at temperatures between 4 °C and 28 °C (39 °F and 82 °F). Refrigerated storage is not recommended.
      • Do not freeze.
      • Protect from moisture.
      • Do not use after expiration date.

ChemFil Rock – step-by-step instructions

Shade selection
ChemFil Rock restorative offers five shade options: A1, A2, A3, A4 Opaque, Contrast White.

Cavity preparation

  1. In all cavity classes cavity preparation may be kept to the minimum required for caries removal and for preparation of butt joint margins.
  2. Prepare for a restoration thickness of more than 1 mm.
  3. Prepare butt joints – avoid bevelled margins.
  4. Rinse surface with water spray and carefully remove excess rinsing water with air spray. Do not desiccate the tooth substance – cavity surface should be moist.
  5. Use cotton rolls or rubber dam to isolate the cavity from contamination.

Placement of matrix

  1. In Class II cavities place a matrix (e.g. AutoMatrix matrix system or Palodent matrix system) and wedge. Burnishing of the matrix band will improve contact and contour. Pre-wedging or BiTine ring placement is advocated.
  2. Use a dead soft, thin matrix band. Contact surface of steel matrix can be coated with a water soluble or petroleum lubricating jelly.
  3. In Class V cavities cervical matrices may be used.

Pulp protection
In deep cavities cover the dentin close to the pulp (less than 1 mm) with a hard-setting calcium hydroxide liner (Dycal calcium hydroxide liner, see complete Instructions for Use) leaving the rest of the cavity surface free for bonding.

Application
Time after activation

rock1

Activation of the capsule
Activate the capsule by pressing the capsule onto a stable surface and depressing the plunger to its limit (at this position the plunger will overlap by about 2 mm).

Mixing
Immediately place the activated capsule in a capsule mixer (4000-4500 oscillations/ minute) and mix for 15 seconds
– or –
in a rotation mixer (e.g. RotoMix 2) for 12 seconds of rotation and 3 seconds of centrifugation mixing.

Application of ChemFil Rock restorative

  1. Immediately remove the capsule from the capsule mixer and place into the Capsule Extruder 2. The capsule may be rotated 360° to gain the proper angle of entrance into the cavity. Do not apply excessive force.
  2. Click the trigger of the Capsule Extruder 2 until glass ionomer paste is seen through the clear nozzle. Immediately start dispensing. Begin dispensing at the deepest part of the cavity, keeping tip close to cavity floor. Gradually withdraw tip as cavity
    is filled. Avoid lifting the tip out of dispensed material while dispensing to minimize air entrapment. At the completion of dispensing, wipe tip against cavity wall while withdrawing from the operative field.
  3. Start packing, excess removal and contouring immediately after placement.
  4. After application, press the release button of the Capsule Extruder 2 until the push rod releases. Slightly rotating the capsule, the empty capsule can easily be removed.

Working and setting time

  • After activation the working time is 1 minute 30 seconds.
  • Wait at least 4 minutes  30  seconds after end of working time before further manipulation.

Finishing
Start finishing no earlier than 4 minutes 30 seconds after end of working time (i.e. 6 minutes after activation) with cups, discs, and points (Enhance Finishing System).

Hygiene
Capsule Extruder 2
Cleaning Clean Capsule Extruder 2 by scrubbing with water and soap.

Disinfection

  1. Disinfect the Capsule Extruder 2 with an alcohol-based surface disinfectant according to national/local regulations.
  2. Follow the disinfectant manufacturer’s Instructions for Use.
  3. Rinse and dry.

Sterilization
Sterilize Capsule Extruder 2 by steam autoclave at 134 °C/2 bar = 273 °F/29 psi, unwrapped; sterilization time 3 minutes 30 seconds.

Lubrication
Regularly apply dental instrument lubricant. Do not continue to use damaged or soiled Capsule Extruder 2. Capsule Extruder 2 can be reprocessed for up to 1,000 times.

NOTICE
Wrong cleaning method
Damage to the Capsule Extruder 2.

  • Do not submerse into disinfection solutions.
  • Do not ultrasonic clean.

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