Instructions For Use: Straumann® Variobase® For Crown And Straumann® Variobase; For Crown As (Angled Solution); Compatibility Information - Straumann Variobase Gebrauchsanweisung

English Instructions for use: Straumann® Variobase® for Crown and Straumann® Variobase®

for Crown AS (Angled Solution)

1. Product description
Abutments
Abutments are placed into dental implants to
provide support for prosthetic reconstructions
such as crowns and bridges.
The Straumann® Variobase® concept consists of
an abutment to be used with an individually ad-
justed mesostructure that is cemented onto it.
The mesostructure can be used as the abutment
or a full contour crown.
Basal Screws
Basal screws are used for the fixation of the abut-
ment to the dental implant.
2. Intended use
Prosthetic components directly connected to the
endosseous dental implant are intended for use
as an aid in prosthetic rehabilitations.
3. Indications
The Straumann® Variobase® is a titanium base
placed onto Straumann dental implants to pro-
vide support for customized prosthetic resto-
rations. Straumann® Variobase® for Crown and
Straumann® Variobase® for Crown AS are indicat-
ed for screw-retained single tooth or cement-re-
tained single tooth and bridge restorations.
4. Contraindications
Please consider any potential allergies or hy-
per-sensitivity to chemical ingredients, please
refer to the label.
Device Material
Straumann® Variobase® for
Titanium alloy, Ti-6Al-7Nb
Crown, Screws
(titanium-aluminum-
Straumann® Variobase® for
niobium or TAN).
Crown AS, Screws
5. Warnings and Precautions
Straumann devices must be secured to prevent
ѹ
aspiration or swallowing during intraoral han-
dling.
Failure to follow the procedures outlined in
ѹ
these instructions may lead to any or all of the
following complications:
Aspiration or swallowing of a component
–
Breakage
–
Infection
–
The Straumann® Variobase® is a single-use de-
ѹ
vice and must not be resterilized. Use devices
immediately after sterilization. Do not store
sterilized devices.
Sterile handling is essential. Never use potential-
ѹ
ly contaminated components. Contamination
may lead to infections.
Place implant-borne restorations only in occlu-
ѹ
sion when the implant is completely osseointe-
grated.
Dental cement or any other material used for the
ѹ
attachment of prosthetic components should
be processed as specified by the manufacturer.
An implant is only to be restored with the cor-
ѹ
responding original abutment compatible with
that specific implant.
When modifying a Straumann® Variobase® for
ѹ
Crown and Straumann® Variobase® for Crown
AS with adjustable chimney height, do not cut
lower than the mark on the abutment to assure
abutment stability.
User shall pay attention when using the
ѹ
Straumann® Variobase® for Crown AS with
prosthetic components realized with a non-val-
idated workflow. For such prosthesis an angula-
tion of 20° maximum is recommended. Proper
functionality of the Straumann® Variobase® for
Crown AS is not guaranteed for greater angu-
lations.

6. Compatibility information

Straumann implants and the prosthetic compo-
nents are available in a variety of configurations
to meet your clinical needs. The label on each
product uses abbreviations to help you identify
whether a particular abutment or coping is com-
patible with the implant that you are restoring.
The implant as well as the prosthetic component
contains an identifier for the connection type,
summarized in the table below.
Implant connection type Compatible prostheses
NC (Narrow CrossFit®) parts labeled NC
RC (Regular CrossFit®) parts labeled RC
NNC (Narrow Neck CrossFit®) parts labeled NNC
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
Please note that the Straumann® Variobase® for
Crown AS requires the use of its dedicated screw
and screwdriver, recognisable by the green color
which identify all the Straumann Angled Solution
components.
7. Cleaning and Disinfection
Straumann® Variobase® for Crown and
Straumann® Variobase® for Crown AS are
non-sterile when delivered. Before placing the res-
toration in the patient's mouth, the product must
be cleaned, disinfected and sterilized. Straumann
recommends the following procedure for cleaning,
disinfection and sterilization of abutments prior
to use:
1. Clean rinsing under flowing water while brush-
ing outer and inner side with adequate 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.
8. 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
enve-lope folding technique and sterilize according to the
following parameters.
Moist Heat (Autoclave) 132 °C (270 °F)
Pre-Vacuum Displacement for 4 min
Note: User in the United States should ensure
that the sterilizer and all sterilization accessories
(sterilization wraps, sterilization trays, biological
indicators and chemical indicators) are cleared by
FDA for the intended sterilization cycle.
User should consult the coping/restoration mate-
rial manufacturer's recommendations regarding
sterilization.
Caution: Use devices immediately after steriliza-
tion. Do not store sterilized devices.
If visible signs of moisture are present (damp spots
on sterile packaging, pooled water in the load) at
the end of the sterilization cycle, repackage and
re-sterilize using a longer drying time.
Consult the brochure Guideline for Cleaning,
Disinfection and Sterilization for Straumann® Im-
plant-borne Prosthetic Components (152.802/en)
for detailed information.
Drying Time
Local practice
30 min
2