VIDU VI93400 Pit and Fissure Sealer Instruction Manual

June 12, 2024
VIDU

**VIDU VI93400 Pit and Fissure Sealer Instruction Manual

**

PIT AND FISSURE SEALER

Pit and Fissure sealer white, light curing, caries-prophylaxis.
“THE FUTURE IS IN YOUR HANDS”

INSTRUCTIONS FOR USE

Patient target group
Children, adolescents, adults and older patients

Intended users
Dentist

Composition
Qualitative data:
Oligomeric methacrylate’s, sodium fluoride, camphor quinone, inorganic fillers

Quantitative data in % w/w:
Methacrylate’s 79, inorganic fillers 20, sodium fluoride 1

Intended purpose of the product
PIT AND FISSURE SEALER VIDU is a light-curable composite for sealing fissures.

Indications
PIT AND FISSURE SEALER VIDU is a light-curing composite with fluoride for fissure sealing.
It is a sealant for occlusal surfaces for the purpose of caries prophylaxis.

Contraindications
The material contains methacrylate’s.
Do not use in patients with known allergy to the ingredients.

Performance characteristics of the product
The composite material cures by irradiation with light.

Specific precautions
None

Application

  1. Clean the surface thoroughly and cover it with an etching gel (orthophoria acid), the blue colour of which facilitates accurate and uniform application.
    Allow the etching gel to react for 60 seconds.
    Reduce etching times for enamel of juvenile teeth to approx. 30 seconds, extend to approx. 120 seconds for low-prism or fluoridated enamel.
    Then rinse thoroughly with sufficient water.
    Dry the surface to be sealed well.
    The etched tooth surfaces should be milky-lime white.
    After drying, contact with liquids should be excluded.

  2. Apply only 1 drop of PIT AND FISSURE SEALER VIDU to a mixing pad and apply a thin layer to the etched surfaces with a brush.
    Then cure with a halogen lamp for 20–30 seconds. Light devices should emit at 450 nm at 500 mW/cm2 and should be checked regularly.
    Place the light as close as possible to the sealer.
    Close carefully after use.

Warnings

Residual risks
The processing instructions and precautionary measures described in the instructions for use of the product must be observed in any case.
If, despite following these instructions, an adverse reaction occurs in the patient or other adverse events occur, we request that you inform us in every case, describing the accompanying circumstances as precisely as possible.

Side effects
Undesirable side effects of this medical device, when the device is properly processed and used, are extremely rare.
Should any adverse effects occur – even in doubtful cases – please inform us, describing the accompanying circumstances and symptoms as precisely as possible.
We follow up on every indication.
No risks in the event of an overdose are known of.

Interactions
Interaction of the product with other medical devices, medicinal products or other substances is not known.

Storage
The Product should be stored between 0° C – 22°C.

Minimum shelf life
Do not use after the expiry date.

Variants
VI93400 PIT AND FISSURE SEALER – 2 syringes x 2,0 ml + cannulas

Disposal
Unused material can be disposed of cured or uncured as methacrylate waste.

All serious incidents related to the device shall be reported to the manufacturer and to the competent authority of the Member.

| Attention: H315 Causes skin irritation
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| Warning: H319 Causes serious eye irritation
ECO DESIGN| CLOSE MANUFACTURE| RESPONSIBLE CONSUMPTION| SMART WASTE| ONLINE DISTRIBUTION
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| | | |

CUSTOMER SUPPORT

Dentared Odontology Services SL
C. Torres Quevedo 13 Alcobendas,
28108, Madrid, Spain
www.vidu.eco
dent a pharm
Produktionsgesellschaft mbH
Schusterring 35, 25355 Barmstedt, Germany
MADE IN GERMANY
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Documents / Resources

| VIDU VI93400 Pit and Fissure Sealer [pdf] Instruction Manual
VI93400 Pit and Fissure Sealer, VI93400, Pit and Fissure Sealer, Fissure Sealer, Sealer
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