Dental Direkt DD Ti-Base 2CUT Notice D'utilisation page 9

US UNITED STATES (FDA)
Cleaning / disinfecting:
Automatic cleaning in a washer-disinfector suitable for this application with an
appropriate cleaning program for medical instruments (e.g. "Vario TD Program",
Miele).
The following steps and parameters are recommended:
• Pre-washing step with cold tap water for 1 minute
• Washing step at 55°C +/- 1°C (131°F +/- 2°F) for 10 minutes, e.g. using
Dr. Weigert neodisher® MediClean Dental
• Rinse twice (2 separate steps):
1. First rinsing for 1 minute with cold deionized water <40°C (<104°F)
2. Second rinsing for 2 minutes with cold deionized water <40°C (<104°F)
• Thermal disinfection step with 93°C (200°F) for 5 minutes
• Drying step at 110°C +/- 2°C (230°F +/- 4°F) for 20 minutes
OR
the following manual cleaning procedure:
• Rinse with cold tap water for 1 minute
• Rinse the screw channel using a disposable syringe (min. capacity 10 ml)
• Clean at 60°C +/- 2°C, e.g. using Dr. Weigert neodisher® LM 2 for 10 minutes
at a concentration of 5% in the ultrasonic cleaner
• Neutralize with cold distilled water for 2 minutes
• Rinse in the ultrasonic cleaner using distilled water at 60°C for 10 minutes
Sterilizing:
Double-seal the product in FDA cleared sterilization film conforming to ISO 11607-
1 and sterilize according to validated parameters listed below.
Steam sterilize in a FDA cleared sterilizer with 3x fractionated prevacuum: 132°C
(270°F) for 4 minutes, drying time: 20 minutes.
Caution: After sterilization, the product must be used immediately and must not
be stored. DD Ti-Base 2CUT, DD Implant Screw and DD Lab Screw are suitable for
single use only. Reuse may result in hazards due to infections.
Workflow:
1. Conventional impression or intra-oral scanning
Impression of the teeth setup could be done by conventional impression technique
or by intra-oral scanning.
DD Scanbody 2.0 should be used for both.
The DD Scanbody 2.0 is used to record the position of the implant in the mouth,
or on the model during the scanning process. Both the position of the implant and
the rotation are depicted due to the asymmetric form of the DD Scanbody 2.0. It is
important to select the correct DD Implant Library for referencing the position.
The DD Scanbody 2.0 is supplied for use on the model with a laboratory screw and
with a silver-coloured implant screw for use in the patient's mouth. The surface
must be clean and free of grease before scanning.
1.1 Conventional impression (Semi-digital workflow)
Take a conventional impression of the patient's tooth set-up and create a working
model with the analog inserted to represent the implant.
Place the DD Scanbody 2.0 into the analog (i.e. DD Fusion analog) to determine the
position and orientation of the implant.
Scan the working model by use of a desktop scanner (i.e. MEDIT T710).
1.2 Intra-oral scanning (Digital workflow)
To detect the exact implant position, use the DD Scanbody 2.0.
Selection must be carried out according to the compatibility of the implant system
and the platform diameter. Scan the patient's teeth setup by use of a dental
intra-oral scanner (i.e. MEDIT i700).
2. Preparation of the DD Ti-Base 2CUT
In the laboratory, the technician selects the DD Ti-Base 2CUT that corresponds to
the implant to be restored. DD Ti-Base 2CUT is supplied with a chimney height of
6 mm. The chimney height can be shortened at predefined grooves to a height of
5 mm or 4 mm by using a 0.3 mm thick fiber reinforced cutting disc. The geometry
of the titanium bonding base must not be processed in any way except for shor-
tening the chimney height and removing the burr from the edges.
3. Designing the zirconia superstructure (Hybrid abutment)
The customized abutment must be designed using CAD Software Dental Direkt de-
signer by exocad® (DentalCAD; K193352) with CAD Module DD Abutment Creator
(Implant Module by exocad®, K193352) with the relevant library file installed.
CAD Software and CAD Module can be purchased from our website:
www.dentaldirekt.de/en
Dental Direkt GmbH · Industriezentrum 106 – 108 · 32139 Spenge · Germany · Tel.: +49 5225 863190
eIFU_DD Ti-Base 2CUT_Rev.08_20240219
Instructions for use
DD Ti-Base 2CUT
The library file can be downloaded from:
www.dentaldirekt.de/en/downloads.
Operation manual and tutorial videos for exocad® DentalCAD and Implant Module
can be found on: www.wiki.exocad.com/wiki/index.php/Main_Page
Import the digitalized patient data to the design software (CAD Software Dental
Direkt designer by exocad® with CAD Module DD Abutment Creator). It is recom-
mended to use always the latest version of the software.
Use appropriate library file and select relevant implant platform from the library.
Design the abutment in the design software according to the parameters.
The following parameters must be observed for the customized abutment:
Parameter
Abutment Post Height
Margin height
Diameter
Wall thickness
Angle from axis of implant
4. Milling the zirconia superstructure (Hybrid abutment)
The zirconia superstructure must be made from DD Bio Z or DD Bio ZX² from Dental
Direkt.
All digitally designed custom abutments for use with DD Solid Connect® CAD/
CAM Abutments are to be sent to a Dental Direkt validated milling center* for
manufacture.
registered milling center for manufacture, validated by Dental Direkt GmbH.
After milling, the abutment will be sent back to the dental lab for finalization.
5. Cementing the zirconia superstructure (Hybrid abutment)
Preparation of the DD Ti-Base 2CUT and the zirconia superstructure
(Hybrid abutment):
Protect the implant-titanium base connecting surface and the screw channel with
wax or silicone, or seal with Teflon tape or a foam pellet.
Sandblast the joining surface with Al₂O₃ 110µm and blasting pressure of max. 2
bar. Remove the wax and abrasive material residue thoroughly using an instrument,
steam jet cleaner and/or ultrasonic bath. Then dry with air.
Apply the bonding agent (Monobond Plus Primer by Ivoclar Vivadent®) to the thus
prepared surface.
Do not touch or otherwise contaminate the conditioned surface.
Place the DD Ti-Base 2CUT with the DD Lab Screw (blue) on the working model.
To protect the implant-titanium base joining surface and the screw channel prior
to the cementation, apply wax or silicone again or seal with Teflon tape or a foam
pellet.
Cementing of the zirconia superstructure (Hybrid abutment):
As dental cement Multilink Hybrid Abutment Cement by Ivoclar Vivadent® is
recommended. The manufacturer's instructions must be followed.
Bond the milled zirconia superstructure to the DD Ti-Base 2CUT. The milled zirconia
superstructure must fit onto the universal base without gaps.
Immediately remove excess cement from the DD Ti-Base 2CUT.
Caution: For use in the model, only use the laboratory screw (max. torque:
10 Ncm).
The titanium bonding base must not show any damage. Only an intact and correct
implant interface ensures correct use of the abutment.
6. Finalizing
After cementation, complete the crown/bridge restoration following routine labora-
tory procedures.
Caution: It is imperative to ensure adequate suction when processing.
Metal dust is harmful to the health, so always use breathing protection and protec-
tive glasses.
7. Use and handling for the dentist
The dentist receives the final dental restoration / working model with the DD Lab
Screw (blue) from the dental lab.
Clean, disinfect and sterilize the dental restoration according
to the instructions above.
Insert the dental restoration into the patient´s mouth with the silver-coloured
implant screw (DD Implant Screw) using a dental torque wrench with a suitable
screw driver.
Specification
4 mm – 6.5 mm
0.5 mm – 6 mm
7 mm maximum
0.5 mm minimum
0° - 20°
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