Adverse Reactions - Dentsply Sirona Neo Spectra ST flow Instrucciones De Uso

2.2 Precautions
This product is intended to be used as specifically outlined in these Directions for Use. Any use of
this product inconsistent with these Directions for Use is at the discretion and sole responsibility
of the practitioner.
• If refrigerated, allow material to reach room temperature prior to use.
• Contact with saliva and blood during composite placement may cause failure of the restoration.
Use of rubber dam or adequate isolation is recommended.
• Use protective measures for the dental team and patients such as glasses and rubber dam in
accordance with local best practice.
• Devices marked "single use" on the labeling are intended for single use only. Discard after use.
Do not reuse in other patients in order to prevent cross-contamination.
• The syringes cannot be reprocessed. To prevent syringes from exposure to spatter or spray
of body fluids or contaminated hands it is mandatory that the syringes are handled with clean/
disinfected gloves. Discard syringes if contaminated.
• As additional precautionary measure, syringes may be protected from gross debris but not from
all contamination by applying a protective barrier.
• Use of Compula
• The Compules
Compula Tips.
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• For further information please refer to the Dentsply Sirona Compules
Use.
• The shade guide and the individual shade guide tabs cannot be reprocessed. To prevent the
shade guide and the individual shade guide tabs from exposure to spatter or spray of body fluids
or contaminated hands it is mandatory that the shade guide and the individual shade guide tabs
are handled with clean/disinfected gloves.
• The material should extrude easily. DO NOT USE EXCESSIVE FORCE. Excessive pressure
may result in unanticipated extrusion of the material or cause the Compula
eject from the Dentsply Sirona Compules
• Tightly close syringes immediately after use. Do not allow dispensing tip to remain as a syringe
cap. Replace original cap tightly after each use. Discard and properly dispose dispensing tips
after use, as the tips may clog if material is allowed to dry or set inside.
• Dentsply Sirona supplies the appropriate dispensing tip for the Neo Spectra™ ST flow composite
restorative material syringe. This tip is the only tip that should be utilized for placement of the
material.
• Insufficient data exist to support the use in Class I cavities with isthmus widths beyond central
groove areas, or when replacing a functional cusp. Excessive wear or restoration failure may
result.
• Insufficient data exist to support the use in Root canal fillings. Restoration failure may result.
• Interactions:
– Do not use eugenol- or hydrogen peroxide-containing materials in conjunction with this prod-
uct because they may interfere with hardening and cause softening of the polymeric compo-
nents of the material.
– The Neo Spectra™ ST flow composite restorative is light cured material. Therefore, it should
be protected from ambient light. Proceed immediately once material has been placed.
– If mineral-impregnated (e.g., ferric compounds) retraction cords and/or hemostatic solutions
are used in conjunction with adhesive procedures, marginal seal may be adversely affected,
allowing microleakage, subsurface staining and/or restoration failure. If gingival retraction is
necessary, use of plain, non-impregnated cord is recommended.

2.3 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).
Tips with the Dentsply Sirona Compules
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Tips Gun is only intended to be used with Dentsply Sirona Compules
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Tips Gun is recommended.
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Tips Gun.
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Tips Gun Directions for
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Tip to rupture or to
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or
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