Dentsply Sirona Celtra Duo Instrucciones De Uso

Celtra® Duo
CAD Blocks for CEREC® and INLAB®
DIRECTIONS FOR USE – ENGLISH
For dental use only.
1. PRODUCT DESCRIPTION
Celtra® Duo Zirconia-Reinforced Lithium Silicate (ZLS) block for
CEREC® and inLab® is a high-strength glass-ceramic material
that, thanks to its translucent properties, can be used for the
fabrication of highly esthetic all-ceramic restorations using a
CAD/CAM procedure. Indirect restorations are fabricated by
milling Celtra Duo using a Dentsply Sirona CAD/CAM system.
Celtra Duo is a zirconia-reinforced lithium silicate (ZLS) block
delivered in a fully crystallized, tooth colored state. It provides
two different processing pathways where the material can be
milled, polished and seated for a flexural strength of 210 MPa
using a three-point bending test method; bi-axial test method
is 413 MPa.
Alternatively, a heat firing cycle will increase the material's flexural
strength to 370 MPa using a three-point bending test method; bi-
axial test method is 560MPa. The use of stains and glaze is optional.
In clinical situations where maximum strength is needed, it is rec-
ommended to fire the restoration. If the mill and polish option is
chosen, all polishing steps must be followed to achieve the in-
crease in strength; see section 3.3.1
1.1 Composition
Zirconia-reinforced lithium silicate (ZLS), type II dental ceramic
material, Class 2a pursuant to DIN EN ISO 6872 (CTE 25–500°C:
11.6 10 K ).
-6 -1
1.2 Indications
Celtra Duo is a fully crystalized zirconia-reinforced lithium silicate
glass ceramic processed through CAD/CAM technique for the
fabrication of:
• Single unit dental restorations, for example all-ceramic crowns,
inlays, onlays and veneers.
Celtra Duo can be used as a material for fully contoured applications.
1.3 Contraindications
• Full veneers on molar crowns
• Very deep subgingival preparations
• Patients with a greatly reduced dentition
• Patients with bruxism
1.4 Compatible porcelains, stains and glazes
The use of stains and glaze is optional with Celtra Duo. Celtra
Duo restorations are compatible with Dentsply Sirona's Universal
Stains and Glaze System or Celtra Stains and Glaze System (avail-
able separately, see complete Directions for Use). The use of oth-
er stain and glaze systems is not recommended (see Warnings).
Celtra Duo is compatible with and thermally matched to Celtra
Correction Porcelain for desired contour adjustments (if neces-
sary). Use of other correction porcelain with Celtra Duo is at the
discretion and sole responsibility of the user.
1.5 Compatible luting cements
Celtra Duo restorations are compatible with adhesive bonding
resin cement systems, including all Dentsply Sirona adhesive resin
cement systems (available Separately (see complete Directions
for Use).
It is our recommendation that Celtra Duo be adhesively bonded
regardless of indication. Full coverage crown restorations that
have a retentive prep design and have been fired are compatible
with self- adhesive resin cements, including all Dentsply Sirona
self-adhesive resin cements (available separately, see complete
Directions for Use). Inlays, onlays, non-retentive crowns should
be adhesively bonded. Use of other cements or cement systems
with Celtra Duo is at the discretion and sole responsibility of the
dental practitioner.
2. GENERAL SAFETY NOTES
Be aware of the following general safety notes and the special
safety notes in other sections of these directions 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 message that follow this symbol to
avoid possible injury.
CAUTION
2.1 Warnings
• If properly processed and used, adverse effects of these medical
products are highly unlikely. However, reactions of the immune
system (such as allergies) or localized paresthesia (such as an ir-
ritating taste or irritation of the oral mucosa) cannot be complete-
ly ruled out as a matter of principle. In case of skin sensitization
REV 2018-01 or rash, discontinue use and seek medical attention.
• Celtra Duo restorations are not suitable for patients with clinical
symptoms of parafunctional habits or bruxism (see Contra-
indications).
• Do not inhale dust particles during grinding. Wear suitable
protective mask.
• Do not use ceramic pins, firing pastes, or any third-party porce-
lains or stains and glazes. Such use may result in cracks in
Celtra Duo restorations.
• In patients with hypersensitivity to any of the ingredients, this
medical device may not be used at all or only under the particular
scrutiny of the dentist or physician in charge.
EN
2.2 Precautions
• This product is intended to be used only as specifically outlined
in these Directions for Use. Any use of this product inconsistent
with the Directions for Use is at the discretion and is the sole re-
sponsibility of the practitioner.
• Wear suitable protective eyewear, clothing and gloves. Protective
eyewear is recommended for patients.
• Contact with saliva, blood and/or some astringent solutions
during adhesive procedures may cause failure of the resto-
ration. Use of rubber dam or adequate isolation is recommended.
• 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.
• Celtra Duo restorations require adequate preparation reduction
and restoration thickness. Insufficient wall thickness may lead
to premature failure.
• Celtra Duo restorations are designed to be completely polished
and/or fired before insertion. Direct insertion without following
all of the polishing steps and/or firing may lead to failure.
• Use only in well ventilated areas.
2.3 Interactions
• Celtra Duo blocks are designed to be fabricated using a
Dentsply Sirona CAD/CAM system. Cutting blocks using
non-compatible CAD/CAM system may lead to inadequate
or unacceptable restorations.
2.4 Adverse reactions
No adverse reactions have been reported for Celtra Duo. Should
you hear or receive information about any adverse effects – even
when doubtful – please 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. Protect
from moisture. Do not use after the expiration date.
3. STEP-BY-STEP INSTRUCTIONS
3.1 Preparation
Proper reduction of the hard tissue of the tooth during prepara-
tion is essential for maximizing the strength, shade and retention
of the finished restoration. When preparing anterior or posterior
teeth, the anatomical form has to be reduced as shown.
Minimum wall thickness: The following diagram shows the speci-
fied minimum wall thickness for each indication. The minimum wall
thickness must still be ensured after all manual adjustments have
been made.
Crown
posterior
1.5 * 1.5 *
1.5 *
1,5 1,5
1,0
1.0
* 1.5-2mm for frameworks that are exclusively polished.
3.1.1 Inlays and onlays
• A conventional inlay/onlay design is recommended. Do not
prepare undercuts. Ensure that the cavity walls form an angle
of 5 – 6 degrees with the long axis of the tooth. Ensure that all
sharp edges and angles are rounded. In centric and dynamic
occlusion, reduce incisally/occlusally by 1.5 to 2 mm.
• Celtra Duo inlays and onlays are ideally delivered by fully adhe-
sive cementing. Alternatively, highly retentive inlay or onlay res-
torations may be cemented with self-adhesive resin cements.
See complete Directions for Use of the adhesive and cement
products.
3.1.2 Full crowns
• Ensure that there is an axial reduction of 1.0 to 1.5 mm with the
walls form an angle of 5 – 6 degrees with the long axis of the
tooth. In centric and dynamic occlusion, reduce incisally/occlu-
sally by 1.5 mm. The lingual shoulders must be extended at
least 1.0 mm into the proximal contacts surfaces. It is recom-
mended to use a shoulder preparation without a bevel: All an-
gles must be rounded, and the preparation surfaces must be
smooth.
• Celtra Duo full crowns can be delivered by fully adhesive or
self-adhesive cementing. See complete Directions for Use of
the adhesive and cement products.
Crown Inlay
anterior
1.5
1.5
1.5
1.5
1.0 1.0
Onlay Veneer
1.0 – 1.5
2.0
1.5
0.6
1,5 mm
0.4
1