Dental Direkt 2402 DD Ti-Base 2CUT noLock Instructions
- June 1, 2024
- Dental Direkt
Table of Contents
**Dental Direkt 2402 DD Ti-Base 2CUT noLock Instructions
**
Contents
1 x DD Ti-Base 2CUT noLock
(titanium bonding base, can be shortened, non-engaging)
1 x DD Lab Screw, blue
1 x DD Implant Screw, silver
Product description:
The Dental Direkt Ti-Base 2CUT noLock is used as a titanium bonding base for
customized bridge and bar restorations. The titanium bonding bases are
available for various implant systems and consist of a prefabricated implant
interface, a screw channel, a circumferential platform for
shaping the emergence profile and a cylinder that can be shortened for
customized patient care. Dental Direkt titanium bonding bases are made of
Ti6AI4V (medical grade 5) for single use and are supplied non-sterile, each
with a separately packaged Implant and Lab Screw.
Caution: Dental Direkt titanium bonding bases must only be used in
combination with the DD Implant Library.
Intended purpose:
DD Solid Connect® implant components are used to support prosthetic
restorations in combination with endosseous dental implants in the upper
and/or lower jaw.
Indication:
For attachment of customized bridge and bar restorations.
Contraindication:
- Intolerance to the constituents
- Restorations with an angulation correction of more than 25° to the implant axis
Please note: Observe the contraindications specified by the original
implant manufacturer used in each case.
Intended users :
DD Solid Connect® implant components should only be used by dentists and
dental technicians in compliance with the procedures in the instructions for
use.
Intended patient group:
Fixed restorations using Dental Direkt Solid Connect® implant components are
suitable for the permanent dentition in adult patients of any gender and
nationality.
Instructions for use in the laboratory:
In the laboratory, the technician selects the DD Ti-Base 2CUT noLock that
corresponds to the implant to be placed (see table). DD Ti-Base 2CUT noLock 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 fabric-
reinforced cutting disc. The geometry of the titanium bonding base must not be
altered in any way except for shortening the chimney height and removing the
burr from the edges. Always use an extraction system when cutting and
sandblasting. Metal dusts are harmful to health, so always wear respiratory
protection and safety goggles. During subsequent fabrication of prosthetic
restorations, the minimum wall thickness specified by the material
manufacturer must be observed. The individual restoration is constructed using
dental design software. It is possible to veneer a ceramic abutment using
suitable veneering materials and following the manufacturer‘s instructions.
Veneering must always be completed before bonding. The bonding surfaces of the
titanium bonding base must be treated with Al₂O₃ abrasives 110 μm and 2 bar
max. before bonding. The surfaces are bonded with a suitable luting material
(e.g. Multilink® Hybrid Abutment) in accordance with the manufacturer’s
instructions. After curing, all adhesive residues on basal surfaces and in the
screw channel must be carefully removed. The titanium bonding base must not
display any sign of damage. An undamaged and correct implantinterface is
essential for correct placement of the prosthetic restoration.
Caution: On the model, only use the Lab Screw (max. torque: 10 Ncm).
Instructions for use in the dental practice:
The customized prosthetic restoration is placed in the patient’s mouth using
the silver Implant Screw. In the case of long-span bridge restorations, care
must be taken to ensure that the screw connections are free of stress. To
avoid any stresses, the implant screws are tightened diagonally.
Caution: The Lab Screw must not be used for placement of the implant
components in the patient’s mouth.
Caution : The Implant Screw must be tightened to the torque specified for
the system (see table).
Please note: It is recommended to tighten the Implant Screw 10 minutes
after placement.
Please note: When DD Solid Connect® implant components are used for
restorations with reduced-diameter implants, limited indications apply. These
can be found in the relevant instructions for use from the implant
manufacturer.
Please note: DD Solid Connect® implant components from a particular
series can only be combined with the corresponding compatible implant
system.This also applies to the corresponding platform diameters.
Material:
DD Ti-Base 2CUT noLock, DD Implant Screw and DD Lab Screw are all made of
Ti6Al4V (medical grade 5) ASTM 136 ELI.
Cleaning, disinfection and sterilization:
DD Solid Connect® implant components and accompanying screws are cleaned at
Dental Direkt, but not sterilized, before being packaged. After customizing,
and before being used on the patient, the implant components must be cleaned,
disinfected and sterilized following the procedure described by Dental Direkt.
Cleaning/disinfection:
Automatic cleaning in a suitable washer-disinfector with an appropriate
cleaning program for medical instruments (e.g. “Vario TD Program”, Miele). 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 in the ultrasonic cleaner at 60°C (140°F) +/- 2°C, e.g. using Dr. Weigert neodisher® LM 2 for 10 minutes at a concentration of 5%
- Neutralize with cold distilled water for 2 minutes
- Rinse in the ultrasonic cleaner using distilled water at 60°C ( 140°F) for 10 minutes
Sterilization:
Double-seal products in sterilization film conforming to EN ISO 11607-1. Steam
sterilize in a suitable sterilizer with 3x fractionated prevacuum: 134°C
(273°F) for 5 minutes,
drying time: 20 minutes. Then store in sterile packaging.
Caution: DD Ti-Base 2CUT noLock, DD Implant Screw and DD Lab Screw are
suitable for single use only. Any reuse may lead to hazards due to infection.
Possible side effects and interactions:
Allergic reactions or skin irritations are possible in very rare cases.
Different alloys in the oral cavity can lead to galvanic reactions when in
direct contact.
Disposal:
In compliance with local regulations.
Warranty:
Our products undergo strict quality control and conform to the latest
technical standards. Please refer to our current warranty terms for further
details.
Please note: Any serious incident that occurs in connection with the
product should be reported to the manufacturer and the competent authority of
the Member State in which the user and/or patient is located Please note:
The safety and clinical performance summary report can be requested at
info@dentaldirekt.de. We are continuously developing and enhancing our
devices, and therefore reserve the right to make changes. The latest version
of the instructions for use can also be found on our website at:
www.dentaldirekt.de/en
This version replaces all previous versions.
Explanation of symbols:
Manufacturer
Date of manufacture
Batch code
Catalog number
Keep dry
Non-sterile
Do not use if package is damaged
Torque
Consult electronic instructions for use www.dentaldirekt.de/IFU
Caution: Under U.S. federal law, the device may only be sold by or on
behalf of a dentist.
Do not re-use
Medical device
Unique device identification
Dental Direkt Series| Compatible with: manufacturer|
System| Size (mm)| Torque (Ncm)
---|---|---|---|---
DD AAS-Serie| DENTSPLY Implants®| Astra Tech®| 3.5 / 4.0| 25
4.5 / 5.0| 25
DD BSK-Serie| Bredent Medical| Sky®| 3.5 – 5.5| 25
DD CCA-Serie| Altatec| Camlog®| 3.3| 20
3.8| 20
4.3| 20
5.0| 20
DD CCO-Serie| Altatec| Conelog®| 3.3| 20
3.8| 20
4.3| 20
5.0| 20
DD DEV-Serie| DENTSPLY Implants®| Astra EV| 3.0| 25
3.6| 25
4.2| 25
4.8| 25
5.4| 25
DD DFX-Serie| DENTSPLY Implants®| Frialit®/Xive®| 3.4| 25
3.8| 25
4.5| 25
5.5| 25
DD MAR-Serie| MegaGen| AnyRidge®| 3.5 – 8.0| 30
DD MMI-Serie| Medentis Medical®| ICX| 3.75 – 4.8| 30
DD MSE-Serie| MIS Implants®| Seven®| 3.3 NP| 30
3.75 / 4.2 SP| 30
5.0 WP| 30
DD NBR-Serie| Nobel Biocare™| Brånemark™| 3.5 NP| 35
4.1 RP| 35
DD NNA-Serie| Nobel Biocare™| Nobel Active®| 3.5 NP| 25
4.3 / 5.0 RP| 35
DD NRE-Serie| Nobel Biocare™| Replace Select®| 3.5 NP| 35
4.3 RP| 35
5.0 WP| 35
DD OTS-Serie| Osstem Implant| TS| 3.5 M| 20
4.0 – 6.0 R| 20
DD SBO-Serie| Straumann®| Bone Level®| 3.3 NC| 35
4.1 / 4.8 RC| 35
DD SSY-Serie| Straumann®| Tissue Level| 4.8 RN| 35
6.5 WN| 35
DD TSP-Serie| Thommen Medical| SPI®| 4.0| 25
4.5| 25
5.0| 25
6.0| 25
DD ZBC-Serie| Zimmer Biomet 3i| Certain®| 3.4|
30
4.1 / 5.0
|
30
DD ZTA-Serie
|
Zimmer Dental
|
Tapered Screw- Vent®
|
3.5
|
30
4.5
|
30
5.7
|
30
Content:
1 x DD Ti-Base 2CUT noLock
1 x DD Lab Screw blue
1 x DD Implant Screw, silver
Indications for Use:
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw.
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
DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant
bodies, Dentsply Implants Astra Tech OsseoSpeed 3.5mm implant bodies, Dentsply
Implants Xive 3.4mm implant bodies, Straumann Bone Level 3.3mm implant bodies,
Zimmer Biomet 3i Certain 3.4mm implant bodies and Zimmer Dental Tapered Screw-
Vent 3.5mm implant bodies are indicated for maxillary lateral and mandibular
central/lateral incisors only.
Compatible Implant Systems:
Dental Direkt Series| Compatible with: manufacturer|
System| Size (mm)| Torque (Ncm)
---|---|---|---|---
DD AAS-Serie| DENTSPLY Implants®| Astra Tech®| 3.5 / 4.0| 25
4.5 / 5.0| 25
DD CCA-Serie| Altatec| Camlog®| 3.3| 20
3.8| 20
4.3| 20
5.0| 20
DD DEV-Serie| DENTSPLY Implants®| Astra EV| 3.0| 25
3.6| 25
4.2| 25
4.8| 25
5.4| 25
DD DFX-Serie| DENTSPLY Implants®| Frialit®/Xive®| 3.4| 25
3.8| 25
4.5| 25
5.5| 25
DD NNA-Serie| Nobel Biocare™| Nobel Active®| 3.5 NP| 25
4.3 / 5.0 RP| 35
DD NRE-Serie| Nobel Biocare™| Replace Select®| 3.5 NP| 35
4.3 RP| 35
5.0 WP| 35
DD SBO-Serie| Straumann®| Bone Level®| 3.3 NC| 35
4.1 / 4.8 RC| 35
DD SSY-Serie| Straumann®| Tissue Level| 4.8 RN| 35
6.5 WN| 35
DD ZBC-Serie| Zimmer Biomet 3i| Certain®| 3.4| 30
4.1 / 5.0| 30
DD ZTA-Serie| Zimmer Dental| Tapered Screw- Vent®| 3.5| 30
4.5| 30
5.7| 30
Device description:
The Dental Direkt Ti-Base 2CUT noLock serves as a titanium bonding base for individualized bridge and bar restorations. The titanium bonding bases are available for various implant systems and consist of a prefabricated implant connection (interface), screw channel, a circumferential platform for designing the emergence profile and a shortenable cylinder for individualized patient care. The Dental Direkt titanium adhesive bases are made of Ti6AI4V (medical grade 5) for single use and are supplied non-sterile, each with a separately packaged implant and laboratory screw.
Caution: The Dental Direkt titanium bonding bases may only be used in
conjunction with the DD Implant Library.
Warning : Small diameter implants and angled abutment are recommended for
anterior region.
Indication:
DD Ti-Base 2CUT noLock: For fixation of individualized bridge and bar
restorations. DD Implant Screw: The implant screw (abutment screw) is used to
fix the abutment to the implant (two-part implant system).
Material:
The DD Ti-Base 2CUT noLock, DD Lab Screw and DD Implant Screw are made of
Ti6AI4V (medical grade 5) ASTM 136 ELI. Contraindication:
- Intolerance to the components contained
- Restorations with an angulation correction of more than 20° to the implant axis
Intended users:
The DD Solid Connect® Implant Components may only be processed by trained,
dental technical / dental medical personnel in compliance with the
specifications in the Instructions for Use
Intended patient group:
Fixed dentures made of Dental Direkt Solid Connect® CAD/CAM Abutments are
suitable for the permanent dentition of adult patients of any gender and
nationality
Possible side effects and interactions:
Allergic reactions or skin irritations are possible in very rare cases.
Different alloys in the oral cavity can lead to galvanic reactions when in
direct contact.
Use in MR (Magnetic Resonance) environment:
MR Conditional
Warning: The RF Safety of the device has not been tested. The patient may
only be imaged by landmarking at least 30 cm from the implant, or ensuring the
implant is located outside the RF coil. A patient with this device can be
scanned safely in an MR system under the
following conditions:
| Device Name | DD Ti-Base 2CUT noLock, DD Implant screw |
|---|---|
| Static Magnetic Field Strength (B0) | ≤ 3.0T |
| Maximum Spatial Field Gradient | 30 T/m (3,000 gauss/cm) |
| RF Excitation | Circularly Polarized (CP) |
| RF Transmit Coil Type | For body transmit coil, landmarking at least 30 cm from |
the implant, or ensuring the implant is located outside of the coil. Extremity
T/R coils permitted. Excludes Head T/R coil.
Operating Mode| Normal Operating Mode in the allowed imaging zone
Maximum Whole-Body SAR| 2 W/kg (Normal Operating Mode)
Maximum Head SAR| Not evaluated for head landmark
Scan Duration| No specific constraints due to implant heating
Cleaning, disinfecting and sterilizing:
The DD Ti-Base 2CUT noLock and the associated implant screws are cleaned at
Dental Direkt, but packed non-sterile. After processing and before use on the
patient, the implant components must be cleaned, disinfected and sterilized
following the procedure described by Dental Direkt
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):
- First rinsing for 1 minute with cold deionized water <40°C (<104°F)
-
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 noLock, DD Implant Screw and DD Lab Screw
are suitable for single use only. Reuse may result in hazards due to
infections.
Workflow :
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-cultured implant screw for use in
the patient’s mouth. The surface must be clean and free of grease before
scanning.
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).
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).
Preparation of the DD Ti-Base 2CUT noLock
In the laboratory, the technician selects the DD Ti-Base 2CUT noLock that
corresponds to the implant to be restored. DD Ti-Base 2CUT noLock 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 diamond
cutting disc. The geometry of the titanium bonding base must not be processed
in any way except for shortening the chimney height and removing the burr from
the edges.
Designing the zirconia superstructure (Hybrid abutment)
The customized abutment must be designed using CAD Software Dental Direkt
designer 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
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
recommended 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 parameter
The following parameters must be observed for the customized abutment:
| Parameter | Specification |
|---|---|
| Abutment Post Height | 4 mm – 6.5 mm |
| Margin height | 0.5 mm – 6 mm |
| Diameter | 7 mm maximum |
| Wall thickness | 0.5 mm minimum |
| Angle from axis of implant | 0° – 20° |
. 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.
After milling, the abutment will be sent back to the dental lab for
finalization.
Cementing the zirconia superstructure (Hybrid abutment)
Preparation of the DD Ti-Base 2CUT noLock 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 noLock 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 noLock. The milled zirconia
superstructure must fit onto the universal base without gaps. Immediately
remove excess cement from the DD Ti-Base 2CUT noLock.
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.
Finalizing
After cementation, complete the crown/bridge restoration following routine
laboratory procedures.
Caution: It is imperative to ensure adequate suction when processing.
Metal dust is harmful to the health, so always use breathing protection and
protective glasses.
Use and handling for the dentist
The dentist receives the final dental restoration / working model with the DD
Labs crew (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-
colouredimplant screw (DD Implant Screw) using a dental torque wrench with a
suitable screw driver
The implant screw should be tightened with the system – specific torque. The
screw channel must always be sealed after the abutment is attached to the
implant.
Caution: The lab screw must not be used for inserting the implant
components in the patient.
Note: Restricted indications apply for the restoration of DD Solid
Connect® CAD/ CAM Abutments on reduced-diameter implants, which can be found
in the corresponding instructions for use of the implant manufacturer.
Note: DD Solid Connect® CAD/CAM Abutments of the respective series can
only be combined with the corresponding compatible implant system. This also
applies to the corresponding platform diameters.
Disposal:
Dispose of waste according to applicable legislation.
Warranty:
Our products are subject to strict quality control and correspond to current
technical standards. Please refer to our current warranty terms and conditions
for further details.
Note: Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent authority to the
Member State in which the user and/or patient is established.
Our products are subject to continual development, so we reserve the right to
make changes. You will find the latest version of the instructions for use on
our homepage at: www.dentaldirekt.de/en
This version replaces the previous.
*Dental Direkt validated milling centers can be found at:
www.dentaldirekt.de/en/validated-milling-centers
Explanation of symbols:
Manufacturer
Date of manufacture
Batch code
Catalog number
Keep dry
Non-sterile
Do not use if package is damaged
Torque
Consult electronic instructions for use
www.dentaldirekt.de/IFU
Caution : U.S. Federal law restricts this device to sale by or on the
order of a dentist
Do not re-use
Medical Device
Unique Device Identification
MR Conditional
Dental Direkt GmbH · Industriezentrum 106 – 108 · 32139 Spenge · Germany · Tel.: +49 5225 863190 10 eIFU_DD Ti-Base 2CUT noLock_Rev.08_20240219
References
- Dental Direkt - close to you
- Dental Direkt - close to you
- Your search results | Dental Direkt
- Downloads | Dental Direkt
- Validated Milling Centers - Dental Direkt
- eIFU - electronic Instructions for Use | Dental Direkt