Dental Direkt 0482 DD Uni Bond Instruction Manual
- June 13, 2024
- Dental Direkt
Table of Contents
Dental Direkt 0482 DD Uni Bond
Product Information
| Product Name | DD Uni Bond |
|---|---|
| Product Description | DD Uni Bond is a one-component silanisation agent for |
durable
adhesive bonding between indirect restorations (also zirconium
dioxide) and luting composites, as well as for the pretreatment of
glass fibre reinforced composite posts.
Indications| DD Uni Bond is used as a coupling agent to achieve optimal
The bond strength between indirect restorations made of either silicate
ceramics, aluminium oxide, zirconium dioxide, metal or composite,
as well as glass fibre-reinforced composite posts, on the one side
and methacrylate-based luting composites on the other side.
Contraindications| DD Uni Bond contains methacrylate phosphoric acid ester and
DD Uni Bond should therefore
not be used in patients with a known hypersensitivity (allergy) to
these ingredients.
Patient Target Group| DD Uni Bond is suitable for use in all patients without
any age
or gender restrictions.
Performance Features| The product’s performance features satisfy the
requirements of
the intended use and the relevant product standards.
User| DD Uni Bond should only be used by a professionally trained
dental practitioner.
Product Usage Instructions
Preparation
Bring material to room temperature before use.
Luting of Indirect Restorations
Surface conditioning of indirect restorations, including those made from
zirconium dioxide, creates optimum conditions for long-term bonding of
restoration and luting composite.
-
Once the fit of the restoration has been checked, prepare its bonding surfaces according to the manufacturer’s instructions for use by etching or sandblasting, rinse carefully with water and dry
with oil-free air. -
When using the bottle: Dispense DD Uni Bond onto a DD Bio Z applicator or a disposable brush. Alternatively, dispense DD Uni Bond onto a mixing pallet. Close the bottle after use.
-
Apply DD Uni Bond onto the prepared surfaces with a DD Bio Z applicator or disposable brush, allow to take effect for 60 seconds and dry carefully with oil-free air.
-
Apply the luting composite as described in the respective instructions for use and place the restoration.
Luting of Glass Fibre Reinforced Posts
- After appropriate preparation of the root canal and position Check the glass fibre reinforced post, shorten the post to operational length according to the manufacturer’s instructions for use, then clean with alcohol and dry with oil-free air.
- Coat the entire post with DD Uni Bond (for details on dispensing from the bottle: see above), allow to take effect for 60 seconds and dry carefully with oil-free air.
- Cement the post in the root canal according to the instructions of the manufacturer.
Note: In case of contamination or time delay, surface conditioning may reduce the bonding strength of DD Uni Bond. Therefore, repeat the surface conditioning steps as described above.
Constituents
The product contains the following constituents (in descending order according
to content): Acetone,
Disposal
Dispose of the product in accordance with local regulations.
Reporting Obligation
Serious events such as death, temporary or permanent serious deterioration of
a patient’s, user’s or other person’s health condition and a serious risk to
public health that arise or could have arisen in association with the use of
DD Uni Bond must be reported to the manufacturer and the responsible
authority.
Instructions for use
Medical device
Product Description
DD Uni Bond is a one-component silanisation agent for durable adhesive bonding
between indirect restorations (also zirconium dioxide) and luting composites,
as well as for the pretreatment of glass fibre-reinforced composite posts.
Indications
DD Uni Bond is used as a coupling agent to achieve an optimal bond the strength between indirect restorations made of either silicate ceramics, aluminium oxide, zirconium dioxide, metal or composite, as well as glass fibre-reinforced composite posts, on the one side and methacrylate-based luting composites on the other side.
Contraindications
DD Uni Bond contains methacrylate phosphoric acid ester and DD Uni Bond should
therefore not be used in patients with known hypersensitivity (allergy) to
these ingredients.
Patient target group
DD Uni Bond is suitable for use in all patients without any age or gender
restrictions.
Performance features
The product’s performance features satisfy the requirements of the intended
use and the relevant product standards.
User
DD Uni Bond should only be used by a professionally trained dental
practitioner.
Use
Preparation
Bring material to room temperature before use. Luting of indirect
restorations: Surface conditioning of indirect restorations, including those
made from Zirconium dioxide, creates optimum conditions for long-term bonding
of restoration and luting composite.
- Once the fit of the restoration has been checked, prepare its bonding surfaces according to the manufacturer’s instructions for use by etching or sandblasting, rinse carefully with water and dry with oil-free air.
- When using the bottle: Dispense DD Uni Bond onto a DD Bio Z applicator or a disposable brush. Alternatively, dispense DD Uni Bond onto a mixing pallet. Close the bottle after use.
- Apply DD Uni Bond onto the prepared surfaces with a DD Bio Z applicator or disposable brush, allow to take effect for 60 seconds and dry carefully with oil-free air.
- Apply the luting composite as described in the respective instructions for use and place the restoration.
Luting of glass fibre-reinforced posts
- After appropriate preparation of the root canal and position check of the glass fibre reinforced post, shorten the post to operational length according to the manufacturer’s instructions for use, then clean with alcohol and dry with oil-free air.
- Coat the entire post with DD Uni Bond (for details on dispensing from the bottle: see above), allow to take effect for 60 seconds and dry carefully with oil-free air.
- Cement the post in the root canal according to the instructions of the manufacturer
Warnings, precautionary measures
- Contamination of the conditioned bonding surface (e.g. saliva or blood) may reduce the bonding strength of DD Uni Bond. Therefore, repeat the surface conditioning steps as described above.
- Contact of DD Uni Bond with skin/mucosa or eyes may have an irritating effect and should be avoided.
- Our information and/or advice do not relieve you of the obligation of checking that the products supplied by us are suitable for their intended purpose.
Constituents (in descending order according to content)
Acetone, phosphoric acid ester
Storage:
Storage at 4°C-23°C. Refrigeration is recommended. Do not use after the expiry
date.
Disposal
Dispose of the product in accordance with local regulations.
Reporting obligation
Serious events such as death, temporary or permanent serious deterioration of
a patient’s, user’s or other person’s health condition and a serious risk to
public health that arise or could have arisen in association with the use of
DD Uni Bond must be reported to the manufacturer and the responsible
authority.
Note
The Summary of Safety and Clinical Performance of DD Uni Bond can be found in
the European database on medical devices (EUDAMED –
https://ec.europa.eu/tools/eudamed)
Manufacturer
Consult instructions for use
Use-by date
Batch Code
Catalog number
Keep away from sunlight
Temperature limit
Medical device
Distributor: Dental Direkt GmbH
Industriezentrum 106–108 | 32139 Spenge | Germany
Tel.: +49 5225 86319-0 | Fax: +49 5225 86319-99
info@dentaldirekt.de |
www.dentaldirekt.de
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>