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Instructions for use: Straumann® CARES® Abutments CoCr
1. Product description
Straumann® CARES® Abutments CoCr are used for
the restoration of Straumann dental implants of
different types, endosteal diameters, lengths and
platforms. The Straumann® CARES® Abutments
CoCr allow for individual customization regard-
ing function and esthetics. Straumann® CARES®
Abutments CoCr are designed by the customer
either by means of a conventional wax-up abut-
ment that is subsequently scanned or by scanning
the intraoral situation and designing the shape
using Straumann-approved software (such as
Straumann® CARES® Visual). The design data is
then transferred to Straumann where the fabri-
cation of the customized abutment is carried out.
The Straumann® CARES® Abutments CoCr can be
directly veneered.
These instructions for use are valid for Straumann®
CARES® Abutments CoCr of the following pros-
thetic lines: synOcta® (RN and WN), CrossFit® (NC
and RC), TorcFit® (RB/WB and WB).
2. Intended use
Prosthetic components connected to the implant
are intended for use as an aid in prosthetic reha-
bilitation.
3. Indications for use
The Straumann® CARES® Abutments CoCr are in-
dicated for single tooth replacement and multiple
tooth restorations.
The prosthetic restoration can be cemented or
directly veneered/screw-retained.
4. Contraindications
Do not use in a patient with a known intolerance
to the materials indicated in the following table:
Device
Material
Screw, Abutment
Titanium alloy, Ti-6Al-7Nb
(titanium-aluminum-niobium or
TAN) and coron® (cobalt-chromium
alloy): Co, Cr, W, Si, Mn, N, Nb, Fe
5. Warnings
The patient should be provided with information
about side effects, interactions, warnings and pre-
cautions associated with Straumann abutments
and restorations
Straumann prosthetic devices must be secured
ѹ
to prevent aspiration during intraoral handling.
An implant is only to be restored with the cor-
ѹ
responding original abutment compatible with
that specific implant.
Straumann® CARES® Abutments CoCr may be
ѹ
processed, as long as a minimal wall thickness
of 0.4 mm is respected and a polishing aid or
implant analog is used during sandblasting with
AI₂O₃, grinding or polishing to protect the abut-
ment-implant connection.
The screw channel and the implant-connection
ѹ
of the Straumann® CARES® Abutments CoCr
must not be sandblasted with AI₂O₃, ground or
polished. Sandblasting with AI₂O₃, grinding or
polishing of the screw channel or the implant
connection may cause the product to fail. In case
of direct-veneering the oxide layer at the im-
plant-connection should be removed as follows:
Indirect sandblasting with glass beads (50µm)
with 2 bars pressure after the final firing step.
The handling and use of the product are not
within the control of Straumann and are the
responsibility of the user. All liability for loss or
damage is excluded.
Always place temporary restorations out of
ѹ
occlusion.
Place implant-borne restoration only in occlu-
ѹ
sion when the implant is completely osseointe-
grated.
Angled abutments should not be used in areas
ѹ
of high mechanical loads on small-diameter
implants.
Failure to follow the procedures outlined in these
instructions may harm the patient and/or lead to
any or all of the following complications:
Aspiration or swallowing of components;
ѹ
Infection;
ѹ
Damage to the implant, abutment, components
ѹ
or tooling;
Loosening of the abutment or other compo-
ѹ
nents;
lmproper final restoration or malfunction of the
ѹ
crown, bridge, or other final prosthetic;
lmpairment of the patient's chewing function;
ѹ
Failure of the implant;
ѹ
Removal of the implant.
ѹ
6. Cautions
Dental restorations directly connected to dental
ѹ
implants need to be sterile when placed in the
patient's mouth.
Always clean the implant's inner connection
ѹ
before placing the abutment.
Assure sterile handling of the product.
ѹ
7. Magnetic Resonance Imaging (MRI)
Safety Information
These products are fabricated from a metal
material which can be affected by MRI energy.
For further information refer to Straumann pub-
lication 490.131/en, MRI Safety Information, at
http://ifu.straumann.com/ and selecting General
Product Information at the top of the page.
8. Compatibility information
Straumann dental implants and the prosthetic
components are available in a variety of configu-
rations. The label on each product uses abbrevi-
ations to help you identify whether a particular
abutment or coping is compatible with the im-
plant that you are restoring. Both the implant
product name and the prosthetic component
contains an identifier for the connection, as sum-
marized in the table below.
Implant connection type
Compatible prosthetic
devices
NC (Narrow CrossFit®)
parts labeled NC
RC (Regular CrossFit®)
parts labeled RC
RN (Regular Neck)
parts labeled RN
WN (Wide Neck)
parts labeled WN
RB (Regular Base, TorcFit®)
parts labeled RB
WB (Wide Base, TorcFit®)
parts labeled WB
9. Cleaning and disinfection
Straumann® Abutments and components are
non-sterile when delivered. Before placing the
restoration in the patient's mouth, the prod-
uct must be cleaned, disinfected and sterilized.
Straumann recommends the following procedure
for the cleaning, disinfection and sterilization of
abutments prior to use.
1. Clean the abutment rinsing under running wa-
ter while brushing the outside and inside with
suitable brushes.
2. The pre-treated product is to be cleaned/dis-
infected in an automated washer disinfector.
Select the appropriate program according to
the manufacturer's instructions.
10. Sterilization
Straumann® Abutments and components are not
sterile when delivered. Straumann recommends
the following procedure for sterilization prior to
use:
Method
Conditions
Europe:
Individually double pouch the abutment and the basal
screw in sterilization pouches and sterilize according to
the following parameters.
132 °C / 134 °C
Moist Heat (Autoclave)
(270 °F / 273 °F)
Pre-Vacuum Displacement
for 3 min
North America:
Place the abutment and the basal screw individually
in a perforated basket with cover in place and wrap in
two layers of 1-ply polypropylene wrap using sequential
envelope folding technique and sterilize according to the
following parameters.
Moist Heat (Autoclave)
132 °C (270 °F)
Pre-Vacuum Displacement
for 4 min
PMMA with TAN inlay:
Autoclave, moist heat
121 °C (250 °F)
Factionated vacuum
for 20 minutes
Drying Time
Local practice
30 min
Local practice
2
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