Dental Direkt Zirconium Dioxide Milling Blanks Instructions

Dental Direkt Zirconium Dioxide Milling Blanks

Specifications

• Material: Zirconium dioxide milling blanks
• Intended Use: Fabrication of fixed restorations for long-term use
• Indications: Veneers, inlays, onlays, crowns, bridges, hybrid abutment crowns, and cantilever bridges
• Contraindications: Parafunction, insufficient space, unsuitable preparation, intolerance to components, inadequate oral hygiene
• Intended Users: Dentists and dental technicians
• Intended Patient Group: Adult patients of any gender and nationality

**Product Usage Instructions

**

Construction Parameters

• Single crown
• 3-unit anterior bridge
• 3-unit posterior bridge
• Anterior bridge with 4 or more units
• Posterior bridge with 4 or more units
• Connector cross-section to cantilever unit

FAQ
Q: Can the product be used for temporary restorations?
A: No, a provisional fixation is not recommended. The product is intended for long-term use.

Instructions for Use

1. Product description
   The Nacera® Pearl Natural zirconium dioxide milling blank made of yttrium- stabilized zirconium dioxide (5Y-TZP + 3Y-TZP) is a hybridlayer and is suitable for dental application of type II, class 5 in accordance with DIN EN ISO 6872, and they fulfill their material-specific requirements after specified final sintering.

2. Intended purpose
   Dental Direkt zirconium dioxide milling blanks are intended for the fabrication of fixed restorations for long-term use.

3. Indication
   For fabrication of veneers, inlays, onlays, anatomically reduced crowns and bridges*/, fully anatomical (monolithic) crowns and bridges*/*, hybrid abutment crowns and cantilever bridges as anterior and posterior restorations.

   • Up to two adjacent pontics
   • In Canada the indication for bridges is limited to a maximum of six units with up to two pontics
   • Cantilever pontics must not be dimensioned longer than 2/3 of the load-bearing abutment crown from mesial to distal

4. Contraindications
   Parafunction, insufficient space, unsuitable preparation, insufficient dental hard tissue, intolerance to components and inadequate oral hygiene.

5. Intended users
   Dental Direkt zirconium dioxide milling blanks must only be used by dentists and dental technicians in compliance with the procedures in the Instructions for Use.

6. Intended patient group
   Fixed restorations using Dental Direkt zirconium dioxide milling blanks are suitable for the permanent dentition in adult patients of any gender and nationality.

7. Handling and storage
   Before using the material for the first time, check that the packaging and the blank itself are intact. Check whether the contents of the packaging correspond to the declaration on the label. Never use damaged material. Store the blanks only in the original packaging and in a cool, dry place. Avoid vibration and contamination. Ensure that the blank and the frameworks made from it are only handled with dry and clean hands or gloves and that they are under no circumstances contaminated with fluids (such as adhesives or marker pens).

Instructions for Use in the laboratory

Processing / construction
Dental Direkt zirconium dioxide is a sensitive, high-performance ceramic and should be processed with special care, including in the partially sintered state!The following construction parameters must always be considered when fabricating zirconium dioxide constructions:

*Do not position the connector cross-section in the incisal layer but as far as possible towards the body layer!
Please note that the connector cross-section may have to be of larger dimensions, depending on the construction. For example, in the case of long- span posterior bridges connector cross-section between two pontics should be increased to at least 20 mm² if possible. The aim is to achieve an oval connector cross-section; the height of the connector is decisive for stability. The design should avoid sharp edges and acute angles. Frameworks for ceramic veneering should be designed in such a way that they support the veneering ceramic in the area of the cusps and enable an even layer thickness. Chamfer or shoulder preparation is recommended.

Nesting recommendation
For the design and positioning of the construction in the multilayer blank, the individual layer thicknesses can be taken from the following nesting table:

| Nacera® Pearl Natural
---|---
Blank height (mm)| Layers 1+ 2:

Incisal layer (mm / %)

| Layer 3:

Intermediate layer (mm / %)

| Layer 4:

Intermediate layer (mm / %)

| Layer 5:

Body layer cervical (mm / %)

16 mm| 4/25| 4/25| 4/25| 4/25
20 mm| 4/20| 4/20| 4/20| 8/40
25 mm| 4/16| 4/16| 4/16| 13/52

You will achieve the best color match by individually positioning the restoration in the blank (match). Depending on the height of the restoration,
the positioning of the incisal, intermediate and body layer can be individually adjusted in the DD smart CAM 2.0 software to achieve the best possible color gradient.

Please refer to our separate nesting recommendation!

Example of optimum CAM-nesting
CAM Software: DD smart CAM 2.0

Milling, sintering and finishing
The blanks must only be processed with the milling systems intended for this purpose. The specifications of the machine manufacturer must  be observed.
For the highest accuracy of fit, the specific magnification factor is printed on the side of the blank as the code to be used.
After the milling process, the frameworks must be checked for any visual defects (e.g. material spalling or shiny areas on the surface due to worn milling cutters). Damaged or contaminated frameworks must not be processed any further. Constructions made of pre-colored zirconium oxide can be customized with DD Art Elements (with exception: DD Art Elements „purple“) before sintering to full density (observe separate Instructions for Use).

Please refer to our separate sintering instructions!

Sintering cycle with normal furnace filling without cover:

During finishing, avoid additional mechanical effects on the outer surface, such as blasting or grinding. If adjustments to the framework are necessary, they must only be carried out using a water-cooled tool. Avoid heat build-up at all times, as this can cause cracks in the material. Work with very low pressure and with sharp, diamond-grinding wheels. Areas that are under tensile load in clinical use (e.g. connectors) must not be finished. Do not separate at interdental connection sites. Always avoid sharp edges.
Caution: The processing of a blank and finally-sintered framework creates dust which might damage the lungs as well as irritating the eyes and skin. Therefore, avoid inhalation of milling dust during processing. Wear gloves, protective goggles and a face mask to avoid skin irritation.

Ceramic veneering
Please use a veneering ceramic with a suitable coefficient of thermal expansion (CTE) and observe the manufacturer´s recommendation. Slowing down the rate of heating and cooling for heavier constructions is strongly recommended.

For individualising the restoration, painting techniques as well as cut-back and layering techniques, or a combination of both, are suitable.

Instructions for Use in the dental practice

For luting, we recommend conventional cementing with zinc oxide phosphate cements or glass ionomer cements. Luting composites can also be used. Ensure sufficient retention and a minimum stump height of 3 mm. For additional cleaning, the inner surface being bonded may be blasted with aluminum oxide (50 µm at 1-2 bar).
Ensure that the surface is free of grease.
Temporary luting is not recommended!

Material

Chemical composition [Weight. %]

| Nacera® Pearl Natural
---|---
ZrO₂ + HfO₂ + Y₂O₃| ≥ 99,0
Y₂O₃| < 9
Al₂O₃| ≤ 0,1
Other oxides| < 1

Physical properties

| Nacera® Pearl Natural
---|---
CTE (25-500°C)| [10-6 K-1]| ~10,7
Chem. solubility| [µg/cm²]| ≤ 17,5
Fracture toughness (KIC)| [MPa√m]| > 5,5
Flexural strength| [MPa]| 1.050 ± 150

• measured according to DIN EN ISO 6872 in the body layer

Possible side effects and interactions

No known side effects or interactions.

 Disposal

In compliance with local regulations. Non-contaminated and completely emptied packaging can be recycled.
Please note: Observe the information in the latest version of the safety data sheet.

Reporting incidents

• 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 be found on our website at:   www.dentaldirekt.de/en/IFU
• This version replaces all previous versions.

Explanation of symbols

Dental Direkt GmbH · Industriezentrum 106 – 108 · 32139 Spenge · Germany · Tel.: +49 5225 863190 eIFU_Nacera® Pearl Natural_Rev.01_20240523

References

• Electronic instructions for use (eIFU) | Dental Direkt
• Electronic instructions for use (eIFU) | Dental Direkt

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