Dental Direkt DD Ti-Base 2CUT noLock Instruction Manual

Dental Direkt DD Ti-Base 2CUT noLock Instruction Manual

Contents:

1 x DD Ti-Base 2CUT (titanium bonding base, can be shortened)
1 x DD Lab Screw, blue
1 x DD Implant Screw, silver

Product description:

The Dental Direkt Ti-Base 2CUT is used as a titanium bonding base for customized crown and abutment 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, an anti-rotation protection that is used to align the abutment in the vertical axis, 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 crown and bar restorations, incl. an anti- rotation protection for aligning the abutment in the vertical axis

Contraindication:

• Intolerance to the constituents
• Restorations with an angulation correction of more than 30° 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 that corresponds to the implant to be placed (see table). 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 fabric-reinforced cutting disc. The geometry of the titanium bonding base must not be altered in any way except for shortening thechimney 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 implant interface 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.

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, DD Implant Screw and DD Lab Screw are all made of Ti6Al4V (medical grade 5) ASTM 136 ELI

Cleaning, disinfection and sterilization:
DD Ti-Base 2CUT 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).

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%
• eutralize 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 the 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, 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:

Content:
1 x DD Ti-Base 2CUT
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 serves as a titanium bonding base for individualized crown and abutment 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, an anti-rotation guard that serves to align the abutment in the vertical axis, and a shortenable cylinder for customized patient restorations. 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: For the fixation of customized crown and abutment restorations incl. an anti-rotation device for the alignment of the abutment in the vertical axis
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, 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:

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 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):

  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.
   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).

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 shortening 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 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 parameters.
   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°

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 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.

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.
   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: 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
MR Conditional

References

• 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

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