英語版 16-10
Revised November 25, 2020 (Revision 2)

Controlled Medical Device: Zirconia Blank for Dental Milling and Machining

KZR-CAD NANOZRINSTRUCTIONS FOR USE【PRODUCT DESCRIPTION】
1. Common name: Zirconia dental ceramics
2. Material type: Ce-TZP/Al2O3 nanocomposite ceramics
3. Indications and Dental ceramic type:
Substructure ceramic for dental restoration or prostheses
Type II, Class 5 according to EN ISO 6872: 2015

The following minimum thickness has to be observed for theframework design with KZR-CAD NANOZR (after full-sintered):Please note: The minimum dimensions of the KZR-CAD NANOZR
framework before full sintering must be larger by the shrinkage
factor.
Minimum dimensions KZR-CAD NANOZR (full-sintered)【DESCRIPTION OF DEVICE】
KZR-CAD NANOZR is zirconium oxide pre-sintered blocks for open
CAD/CAM systems or manually operated systems. The blank isconstructed mainly from zirconium oxide, cerium oxide and aluminumoxide. They are ideal for indications that require high strength andhigh toughness, such as posterior bridges.
KZR-CAD NANOZR is milled into the required frame shapes by
typical milling systems used by dental technician. The milling frame
must add approximately 17% to the original size, so as to compensate
for shrinkage during the final sintering process. The exact shrinkage
ratio or expansion factor is given according to the milling system used.
【TECHNICAL DATA】
1. Composition of the device
Zirconium oxide (ZrO2) + Hafnium oxide (HfO2)
Hafnium oxide (HfO2)
Cerium oxide (CeO2)
Aluminum oxide (Al2O3)
2. Identified specifications (after sintered)Biaxial flexural strength
Fracture toughness KIc (SEVNB)
Density
Coefficient of expansion (25-500℃)

67.9 wt%< 4.0 wt%
10.6 wt%
21.5 wt%

1290 MPa
8.62MPa√m
5.52 g/cm3
10.0±0.5x10-6/K【Instructions for use】
(1)Framework model and tooth preparation
Fabricate a working model with removable segments as usual. The
directions of the different CAD/CAM systems regarding the plasterto be used must be observed.
*Important for die preparation:- Check the radius of the incisal/occlusal edge on the prepared die(maxilla and mandible).
- The prepared incisal edge should be at least as thick as thediameter of the bur used in the cavity during the CAD/CAMprocess.
- If the incisal edge of the prepared die is thinner than thediameter of the bur, the incisal edge has to be blocked out
accordingly.
-Also observe the information provided by the manufacturer of theCAD/CAM system regarding the die geometry.
(2)Material specific framework parameters
The restoration design is key to the success of durable all-ceramic
restoration.The more attention is given to the design, the better thefinal results and clinical success will turn out to be. The following
basic guidelines have to be observed.
-The KZR-CAD NANOZR material is the high-strength componentof your restoration and must always be given a design that supports
the overall shape and cusps.
-In large preparations and for veneered or partially veneered
restorations, the excess available space must be compensated by
the corresponding dimensions of the high strength and hightoughness KZR-CAD NANOZR component and not by the pressedon or layered-on materials.
The design of the restoration generated by the software has to be
individually adjusted, if necessary, in accordance with the clinicalsituation using the design tools.
- If possible, the connector design should be extended in the verticaldirection, rather than in the horizontal direction.

(3)CAD/CAM manufacturing of framework
Since the KZR-CAD NANOZR framework shrink by approximately
17% during full-sintering, the shrinkage ratio of the respective
batch, which is inscribed on the package label.
The “Expansion” which is inscribed on the package label andproduct label is a magnification of when machining with CAM.
The shrinkage factor then ensures that the milled KZR-CAD
NANOZR restorations demonstrate optimum accuracy of fit after
full sintering. The milling tool should be use of with carbide millingcutters. Do not exceed the maximum amount of abrasive agent. The
milling should be cleaned to avoid cross-contamination (e.g. millingdust, acid).
Contamination may result in deterioration of the frameworks
during sintering.
*Magnification factor
Magnification factor inscribed on the disc label.
(4)Finishing of framework
It is of critical importance to use the correct grinding instruments
for finishing and adjusting KZR-CAD NANOZR. The following
notice have to be observed.
-Non full sintered blanks are susceptible to damage and fracture.
This fact has to be kept in mind during the entire working
procedure.
-All adjustments by grinding should always be carried out while theframework is still in its non-full sintered stage, if possible, do not
use water/oil cooling or contact media (e.g. occlusion spray)-The non-full sintered framework must not be cleaned withultrasonic on water bath or with a steam jet.
-Do not blast the framework with Al2O3 or glass polishing beads.
(5)Final sintering
Once the framework is completely dry, the sintering procedure canbe carried out. During the sintering process, the framework will

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shrink to its final size.
The full sintering of the framework takes place according to thefollowing:- Room temperature to final temperature 1450℃- Hold time at final temperature 2 hours- Cooling down phase up to room temperature: approx. 5℃/min.
The following points should be observed.
-Always keep the sintering auxiliaries clean and free of dust sothat no contamination may be sintered to the framework.
-Do not sintering in vacuum condition.
(6)Framework finishing after full sintering
After checking fitting accuracy such as contact points andocclusion, interior surfaces of the crown should be cleaned bycorundum jets or other applicable means such as subsequentevaporation.
(7)Veneering ceramic
KZR-CAD NANOZR is suitable for veneering with conventional
zirconium oxide veneering ceramics. The thermal expansion
coefficient of KZR-CAD NANOZR can be gathered from thetechnical data.
【Contraindications】- bruxism- insufficient amount of hard tooth structure- insufficient preparation results- insufficient oral hygiene- more than two connected pontics in the area of the posterior teeth- known intolerance to the constituents- caution when handled by children or pregnant women【WARNING AND SAFETY INSTRUCTION】
When processing, please use personal protective clothing (dust mask,protective goggles, protective glove, etc.)【GUARANTEE/DISCLAIMER CLAUSE】
Recommendations regarding the application technique, whether they
are given orally, in writing or in the course of practical instruction,
should be regarded as guidelines. Our products are subject to ongoingdevelopment.
We therefore reserve the right to make changes in handling andcomposition.
Do not use KZR-CAD NANOZR excluding the dental intendedindications.
【DISPOSAL】
When discarding, please follow the laws.
【Storage and Expiry Date】[Storage Method]・Store in a dry indoor place in its original packaging.
【Package】
・Disc x 1