Dentsply Sirona CEREC Zirconia+ Gebrauchsanweisung

CEREC® Zirconia+
CAD Blocks for CEREC®
Instructions for Use – ENGLISH
CAUTION: This is a medical device. For dental use only.
USA: Rx only.
1. PRODUCT DESCRIPTION
CEREC® Zirconia+ CAD/CAM block for CEREC® and inLab® is a
material that can be used for the fabrication of fully anatomic
crowns and bridges in the anterior and posterior region using a
CAD/CAM procedure. Indirect restorations are fabricated by
milling CEREC® Zirconia+ CAD/CAM blocks using a
Dentsply Sirona CAD/CAM system.
Note that CEREC® Version 5.1.3 with Material Pack or higher
or inLab® Version 21.0.0 or higher is required. After milling,
the restorations are sintered in the Dentsply Sirona CEREC®
SpeedFire furnace or another conventional sintering furnace,
such as inFire HTC speed or inLab® ProFire. The sintered
restorations are finalized by polishing or polishing and glazing.
CEREC® Zirconia+ dental ceramic material type II, class 5
pursuant to ISO standard 6872:2015 + Amd.1:2018
1.1. Indications
CEREC® Zirconia+ CAD/CAM blocks are zirconia blocks
for the creation of:
Classic and Speed Sintering:
• Fully anatomic crowns and bridges in the posterior and anterior
tooth region.
• Bridges with maximum two pontics.
1.2. Contraindications
• Insufficient oral hygiene
• Insufficient tooth structure
• Insufficient preparation results
• Insufficient space available
1.3. Composition
Oxides
Y O
2 3
HfO
2
Al O , SiO + shading pigments
2 3 2
The content of ZrO is calculated value
2
= 100 % -(HfO + Y O + Al
2 2 3
1.4. Compatible Stains and Glazes
The use of spray glaze or paint-on stains or glaze is optional with
CEREC® Zirconia+ CAD/CAM blocks. CEREC® Zirconia+ CAD/CAM
blocks are compatible with Dentsply Sirona Universal Stain and
Glaze System, Dentsply Sirona Universal Spray Glaze and Dentsply
Sirona Universal Spray Glaze Fluo.
1.5. Compatible Cements
CEREC® Zirconia+ CAD/CAM block restorations are compatible
with Universal/Self-Adhesive Cement, Adhesive Resin Cement,
and Conventional Cement systems, including all Dentsply Sirona
cement systems (Calibra® Ceram, Calibra® Universal and Calibra®
Bio) designed for Zirconia ceramic cementation (see complete
Instructions for Use of selected cement).
1.6. Technical data
The following specifications apply to CEREC® Zirconia+ resto-
rations that have been sintered in a CEREC® SpeedFire, a inFire
HTC speed, or a inLab® ProFire sintering furnace.
Coefficient of thermal expansion (20 – 500 °C): 10.3 · 10
Flexural strength (3-point flexural strength): > 900 MPa
2. GENERAL SAFETY NOTES
Be aware of the following general safety notes and the special
safety notes in other chapters of these instructions for use.
Safety alert symbol
This is the safety alert symbol. It is used to alert you to
potential personal injury hazards. Obey all safety messages
that follow this symbol to avoid possible injury.
CAUTION
2.1 Warnings
• If properly processed and used, adverse effects from this
medical device are highly unlikely. However, reactions of the
immune system (such as allergies) or localized paresthesia
(such as an irritating taste or irritation of the oral mucosa)
cannot be completely ruled out. In case of skin sensitization
or rash, discontinue use and seek medical attention.
50539266
REV 2021-02
Concen­
Unit
tration
wt.-%
wt.-%
wt.-%
O + SiO + shading pigments)
2 3 2
-6
• CEREC® Zirconia+ CAD/CAM block restorations are not
suitable for patients with clinical symptoms of parafunctional
habits or bruxism.
• Do not inhale dust particles during milling or finishing.
Wear a suitable protective mask.
• Do not use competitive stains and glazes (except as indicated
in 1.4) as it may impact the performance of the material.
• Choosing the wrong glazing program may lead to damage of
the restoration or CEREC® SpeedFire.
• Do not apply glaze to the surface of sintered CEREC® Zirconia+
restorations in an unpolished state. Excessive wear of opposing
surfaces may occur. The restoration must be polished prior to
EN
glaze application (see step-by-step Instructions).
• In patients with hypersensitivity to any of the ingredients,
this medical device may not be used at all or only under the
advice of the dentist or physician in charge.
2.2 Precautions
• This product is intended to be used only as specifically outlined
in these Instructions for Use. Any use of this product inconsistent
with the Instructions for Use is at the discretion and is the sole
responsibility of the practitioner.
• Wear suitable protective eyewear, clothing and gloves.
Protective eyewear is recommended for patients.
• Contamination of the preparation or margin area with saliva,
blood, water, or hemostatic agents during adhesive cementation
may lead to an adhesive failure. Ensure adequate isolation and
tissue management techniques during adhesive cementation.
• Devices marked "single use" on the labeling are intended for
single use only. Discard after use. Do not reuse in other
patients in order to prevent cross-contamination.
• CEREC® Zirconia+ CAD/CAM block restorations require
adequate preparation reduction and restoration thickness.
Insufficient wall thickness may lead to premature failure.
• CEREC® Zirconia+ CAD/CAM block restorations must be
sintered and must be polished, or polished and glazed before
insertion. Direct insertion without sintering and polishing or
polishing and glaze may lead to failure.
• Use only in well ventilated areas.
• Do not cement using provisional cements.
Use of provisional/temporary cements could cause
fracture of CEREC® Zirconia+ restorations.
• Insufficient data exists to support use of CEREC® Zirconia+
CAD/CAM blocks to fabricate partial coverage restorations
(veneers, inlays, onlays), resin-bonded-retainer bridges
("Maryland" bridges), endodontic post and cores,
or implant abutments.
• Avoid adjusting sintered restorations with milling tools,
< 8
especially in the connector area. Flexural strength may be
compromised (see step-by-step Instructions).
< 3
• Use of Dentsply Sirona Universal Spray Glaze Fluo with
CEREC® Zirconia+ restorations may result in a brighter shade
< 2
appearance. Use of Dentsply Sirona Universal Spray Glaze is
recommended if this effect is not desired.
• Conventional sintering may lead to higher chroma.
2.3 Interactions
CEREC® Zirconia+ CAD/CAM blocks are designed to be fabricated
using a Dentsply Sirona CAD/CAM system. Milling blocks using
non-compatible CAD/CAM systems may lead to inadequate or
unacceptable restorations.
2.4 Adverse reactions
No adverse reactions have been reported for CEREC® Zirconia+
CAD/CAM blocks. Should you hear or receive information about
any adverse effects, notify Dentsply Sirona.
2.5. Storage conditions
Inadequate storage conditions may shorten the shelf life and
may lead to malfunction of the product. Store in a dry place
and protect from moisture. Do not use after the expiration date.
3. STEP-BY-STEP INSTRUCTIONS
3.1 Preparation
Proper reduction of the tooth during preparation is
essential for maximizing the strength, shade and retention
of the finished restoration.
K
-1
When preparing anterior or posterior teeth, the anatomical form
must be reduced as shown.
It is recommended to prepare a taper which is between 4° and
8°. The preparation must be performed with either a chamfer or
a shoulder with rounded internal angle.
All internal line angles of a preparation should be rounded.
Minimum wall thickness: The following pictures show the
specified minimum wall thickness for each indication.
The minimum wall thickness must still be ensured after
all manual adjustments have been made:
≥ 0.7 mm
≥ 0.7 mm
≥ 0.7 mm
≥ 0.7 mm
≥ 0.7 mm
1