Dental Direkt DD Ti-Base 2CUT Notice D'utilisation page 8

US UNITED STATES (FDA)
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 Dental Direkt Compatible with: Compatible with:
Series Series manufacturer manufacturer
DD AAS-Serie DD AAS-Serie DENTSPLY Implants Dentsply Implants ® ®
DD CCA-Serie DD CCA-Serie Camlog Altatec ®
DD DEV-Serie DD DEV-Serie Dentsply Implants DENTSPLY Implants ® ®
DD DFX-Serie Dentsply Implants ®
DD DFX-Serie DENTSPLY Implants ®
DD NNA-Serie Nobel Biocare™
DD NNA-Serie Nobel Biocare™
DD NRE-Serie Nobel Biocare™
DD NRE-Serie Nobel Biocare™
DD SBO-Serie Straumann
DD SBO-Serie Straumann ®
DD SSY-Serie Straumann
®
DD SSY-Serie Straumann
DD ZBC-Serie Zimmer Biomet 3i
DD ZBC-Serie Zimmer Biomet 3i
DD ZTA-Serie DD ZTA-Serie Zimmer Dental Zimmer Dental
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
System System Size Size Torque Torque
(mm) (mm) (Ncm) (Ncm)
Astra Tech Astra Tech ® ® 3.5 / 4.0 3,5 / 4,0 25 25
4.5 / 5.0 4,5 / 5,0 25 25
Camlog Camlog ® ® 3,3 3.3 20 20
3.8 3,8 20 20
4.3 4,3 20 20
5.0 5,0 20 20
Astra EV Astra EV 3,6 3.0 25 25
3.6 4,2 25 25
4,8 4.2 25 25
4.8 5,4 25 25
Frialit ® /Xive ® 3,4 5.4 25 25
Frialit ® /Xive ® 3.4 3,8 25 25
4,5 3.8 25 25
4.5 5,5 25 25
Nobel 5.5 3,5 NP 25 25
Active™
Nobel Active ® 4,3 / 5,0 RP 3.5 NP 35 25
Replace 4.3 / 5.0 RP 3,5 NP 35 35
Select ®
Replace 4,3 RP 3.5 NP 35 35
Select ®
5,0 WP 4.3 RP 35 35
Bone Level ® 3,3 NC 35
5.0 WP 35
Bone Level ® 4,1 / 4,8 RC 3.3 NC 35 35
synOcta
® 4,8 RN 4.1 / 4.8 RC 35 35
Tissue Level 6,5 WN 4.8 RN 35 35
Certain ® 6.5 WN 3,4 30 35
Certain ® 3.4 4,1 30 30
4.1 / 5.0 5,0 30 30
Tapered Screw- Tapered Screw- 3,5 3.5 30 30
Vent Vent ® ®
4.5 4,5 30 30
5.7 5,7 30 30
Device description:
The Dental Direkt Ti-Base 2CUT serves as a titanium bonding base for individua-
lized 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 conjunc-
tion 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:
Device Name
Static Magnetic Field Strength (B0)
Maximum Spatial Field Gradient
RF Excitation
RF Transmit Coil Type
Operating Mode
Maximum Whole-Body SAR
Maximum Head SAR
Scan Duration
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.
DD Ti-Base 2CUT, DD Implant screw
≤ 3.0T
30 T/m (3,000 gauss/cm)
Circularly Polarized (CP)
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.
Normal Operating Mode in the allowed imaging
zone
2 W/kg (Normal Operating Mode)
Not evaluated for head landmark
No specific constraints due to implant heating
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