Instruction for Use

 

1. Description

This product is made up of dental implant prosthetic components, which should be placed onto a wide range of dental implant system performed only by professionals trained and qualified in Prosthesis and CAD/CAM over Dental Implants.

 

 

2. Precautions and Warnings

1)    Regarding the systemic aspect, consider the general condition of a patient’s health as the applicable literature. Related to the local aspect, observe the conditions of intra-oral tissues.

2)    This product is recommended to be used only once.

3)    Reuse of this product may cause:  adverse biological effects of residual products, microorganisms and/or substances resulting from previous uses and/or reprocessing; changes in physical, mechanical and chemical properties of products, macro and microstructural, that can put in risk the desired functionality. The reuse of this product does not guarantee its safety and efficacy and disclaims any warranty of products.

4)    Do not use the product if the package is damaged.

5)    Best results are obtained with the use of proper implant systems. The use of instrumentals and/or Implants and/or Prosthetic Components of improper systems do not ensure perfect function and disclaims any warranty of the product.

6)    Ensure that the parts are not swallowed or inhaled by the person who is receiving the product (patient), when applicable.

7)    Take particular care during the waxing to avoid excessive or insufficient interocclusal space.

8)    Be sure it is perfectly fixed to the implant. For this periapical radiographs with the parallelism technique is recommended, when applicable.

9)    The improper planning may endanger the Implant/prosthesis set performance resulting in system faults, such as Implant loss or fracturing, loosening or fracturing of the Prosthetic Screws.

10)  Cautions against adverse events that are likely to be incurred after the use of the medical device, or fatal adverse events that may be incurred by the careless use, and other accidents shall be mentioned.   

11)  Contraindications include following, but are not limited to:

 -       Uncontrollable hypertension, diabetes.     
 -       Leukemia, hemophilia, thrombopenia.     
 -       Patients who have been taking the drugs(osteoporosis) for a long time.     
 -       Alcohol dependence, depression, schizophrenia.     
 -       Radiation therapy on jaw.

 

❖  How to sterilization

This product is of single-use and provided non-sterile in a surgical grade film type packing. The following sterilization methods are recommended accordingly: moist heat (steam) autoclave, gravity-displacement or dynamic-air-removal (fractionated vacuum) cycle, unwrapped, 3-minute exposure at 132 °C (270 °F).  The product must be unwrapped on an appropriate tray. Use the sterilized restoration immediately after sterilization, do not store.

 

 

3. Indications for Use

3.1 Ti Base

Ti Base Abutment is a titanium base placed onto various sorts of dental implants to provide support for customized prosthetic restorations such as Copings, Crowns or Bridges. It is indicated for cement-retained and screw-retained single, bridge or multi-unit restorations.

The Titanium base abutment must not be modified and could have options for straight and angulation (up to 20 degrees). This product is indicated according to the available interocclusal space, existing gingival height and three-dimensional Implant position. It is indicated for cement-retained and screw-retained single, bridge or multi-unit restorations in aesthetic areas installed in the jawbone or jaw. It is open CAD system which is recommended the use of CAD/CAM system using the Exocad® 3 Shape™ or Dental wings®.

COPING/CROWN/BRIDGE CONFECTION BY CAD/CAM TECHNIQUE: 
Use the CAD software, according to the manufacturer’s instructions, when making the Coping, Crown or Bridge. Always finish the Coping/Crown/Bridge before the Ti Base fixation. When you use the digital platform select amongst the wide range of Implant libraries which will be provided by us separately - Titanium Base with an appropriate software platform, this way facilitating the interface drawing between the Coping/Crown/Bridge and Ti Base. This library consists of a set of 3D files containing the milling array required for the Coping/Crown/Bridge geometry.

COPING/CROWN/BRIDGE CONFECTION BY TRADITIONAL TECHNIQUE (E.G. PRESSING OR CASTING): 
Always finish the Coping/Crown/ Bridge before the Titanium Base fixation. Place the Titanium Base on the Analog and perform the waxing on the specific castable Coping for the selected Titanium Base. Perform the casting or pressing and finalize the Coping/Crown/Bridge. The Titanium must be used, in laboratory procedures, as follows: Place the Base component over the plaster model and position the Fixation Screw on its, applying a soft tight using the proper Screwdriver. Protect access to the screw throughout the cementation process. The cement handling must follow the manufacturer instructions. Apply the cement in the outer portion of Ti Base and press the fitting Coping/Crown/Bridge according to the guides. The cemented Coping/Crown/Bridge must be pressed over the Ti Base and the excess cement removed immediately. After the cement setting, the infrastructure is unscrewed from the Analog and the surplus cement remaining the Titanium Base edge is removed.

 

3.2 Lab Analog

It is a prosthetic component for laboratory use, made of Stainless Steel 303F. It has a geometry with channels that favour retention on the plaster model or printed model. It is available in the prosthetic interfaces most of the major implant system.  

It is indicated for use in the laboratory phase while obtaining the plaster model or printed model for making the prosthesis on implant, reproducing the dimensions and positioning of the implant or prosthetic intermediate.

Perform the impression of the implant or prosthetic component by using the corresponding transfer and following appropriate techniques. After obtaining the mould, screw/plug the Analog into the transfer used. When applicable, to tighten the screw, use a maximum torque of 10 N.cm. Pour rubbery materials to simulate the soft tissue of the patient. Pour the plaster on the mould, covering the whole Analog. After the plaster phase has set up, remove (separate) the mould from the plaster. Unscrew/unplug the transfer from the Analog. Or print the model using the library instead of pouring the plaster following the instruction provided the manufacturer of the 3D Printer, and insert the analog to the printed model. The fitting is available to be guaranteed only for 3D Printer supplied Arum 3D.

 

3.3 Model Scanbody / Intraoral Scanbody

The Scanbody is manufactured in high-performance Stainless Steel 303F.

The Scanbody is used during the scanning process of a plaster model or patient oral for the implant, with the purpose to transfer to the CAD/CAM software the exact position and orientation of Analogues on the model. It’s available with specific Screw, can be non-engaging (for bridge; rotational) or engaging (for crown; anti-rotational) in relation to the prosthetic component or Implant fitting. This product is a prosthetic component used to transfer the position of Analogs or intermediaries components during the model scanning through the CAD/CAM technique according to each planned case, respecting diameters and components tolerance indications aiming aesthetics and functionality.

Fit the Scanbody over the Analog in the model. Fasten the Screw using the proper screwdriver. Make sure the Scanbody is well fit in the Analog. There should be no vertical or rotational gap. Gaps indicate that the Scanbody must be repositioned. Follow the instructions delivered with the scanner to scanning instructions. If you use a scanning spray, avoid spraying on Scanbody.

The Scanbody is a prosthetic component used to transfer the position and orientation of the implant or prosthetic component, according to each case planned, respecting dimensions and indications of tolerance of the implants and prosthetic components, aiming for aesthetics and functionality. This product is used over an implant and/or prosthetic components to transfer their positions during the intraoral scan using the CAD/CAM technique. Identify the Scanbody compatible with the interface of the implant/prosthetic component installed. Screw or fit this Scanbody onto the implant/prosthetic component.

Check the fit between the pieces, and make sure there is no rotational or vertical looseness. Looseness indicates that the Scanbody is not properly coupled and should be repositioned. Make sure to align the Scanbody to the axis of insertion of the implant/prosthetic component, preventing lock-ups and damage to the system.
Follow the instructions provided with the scanner used for the scanning procedure; if necessary, sandblast or spray the region for scanning, avoiding the Scanbody, with the spray or liquid for scanning, according to the recommendations of the scanner manufacturer. After scanning, check the alignment between the Scanbody and the CAD/CAM library.

 

3.4 Screw

This product is manufactured in titanium_Ti 6AL-4V ELI in accordance with ASTM F136. It must be handled using adequate drivers and the insertion torque values, when applied, must be respected. ARUM Screw does not present contraindications, providing their intended purposes and indications are correctly followed.

 

 

4. Storage Conditions

Should be stored in a clean and dry location, in a maximum temperature of 40°C and protected from direct sunlight.