DENTSPLY Esthet X HD Manual Del Usario

Esthet X
•
High Definition Micro Matrix Restorative
DIRECTIONS FOR USE – ENGLISH
For dental use only.
USA: Rx only.
1. PRODUCT DESCRIPTION
Esthet•X ® HD High Definition Micro Matrix Restorative is a visible light cured, radiopaque,
composite restorative material for anterior and posterior restorations of primary and
permanent teeth. It is to be used following the application of a suitable dentin/enamel
adhesive and is compatible with all DENTSPLY adhesives designed for use with visible light
cured composite restoratives (see complete Directions for Use of selected adhesive). Use of
other dentin/enamel adhesive systems with Esthet•X
discretion and sole responsibility of the dental practitioner.
1.1 Delivery forms
This one-component, visible light cured composite restorative is available in:
• Predosed Compules ® Tips
• 3g Easy•Twist syringes
The regular body shades are optimized to match the Vita
body, opacious dentin and translucent enamel shades are available for esthetically
demanding applications existing beyond the traditional Vita
shade guide is available to guide the clinician in shade selection and blending technique.
Esthet•X ® HD Restorative material may be used with separately available BisGMA-based
tints and opaquers at the discretion and responsibility of the dental practitioner for
individual custom characterization of the ultimate esthetic direct-placement restoration.
Available Shades
Opacious Dentin Regular Body
White-O = W-O White=W
A2-O Extra Light=XL C1
A4-O A1
B2-O A2
C1-O A3
C4-O A3.5
D3-O A4
B1
B2
B3
1.2 Composition
The resin matrix of Esthet•X ® HD Restorative material consists of a Bis-GMA adduct, a Bis-
EMA adduct, and triethylene glycol dimethacrylate, Camphorquinone (CQ), Photoinitiator,
Stabilizer, Pigments.
The filler combination consists of barium fluoroborosilicate glass with a mean particle size
below 1µm and nanofiller silica (particle size 0.04µm).
1.3 Indications
1. Esthet•X ® HD Restorative material is indicated as a direct restorative for all cavity classes
in anterior and posterior teeth.
2. Esthet•X ® HD Restorative material is indicated as a direct esthetic veneering restorative
material and cosmetic reshaping (e.g., diastema closure, incisal lengthening).
3. Esthet•X ® HD Restorative material is indicated for the indirect fabrication of inlays and
onlays.
1.4 Contraindications
Esthet•X ® HD Restorative material is contraindicated for use with patients who have a
history of severe allergic reaction to methacrylate resins.
2. GENERAL SAFETY NOTES
Be aware of the following general safety notes and the special safety notes in other
chapters of these directions for use.
2.1 Warnings
1. Esthet•X ® HD Restorative material contains polymerizable methacrylates which may be
irritating to skin, eyes and oral mucosa and may cause allergic contact dermatitis in
susceptible persons.
2. Avoid eye contact to prevent irritation and possible corneal damage. In case of contact
with eyes, rinse immediately with plenty of water and seek medical attention.
3. Avoid skin contact to prevent irritation and possible allergic response. If contact with skin
occurs, immediately remove material with cotton and wash thoroughly with water and
soap. In case of skin sensitisation or rash, discontinue use and seek medical attention.
® HD
® HD Restorative material is at the
® system. Additional available
® System. A custom blended
Translucent Enamel
B5/Dark Yellow Clear Enamel=CE
White Enamel=WE
C2 Yellow Enamel=YE
C3 Amber Enamel=AE
C4 Grey Enamel=GE
C5/Extra Grey-Brown
D2
D3
Universal
4. Avoid contact with oral mucosa to prevent inflammation. If accidental contact occurs,
immediately remove material from the tissues. Flush mucosa with plenty of water after
the restoration is completed and expectorate/evacuate the water. If sensitisation of
mucosa persists, seek medical attention.
5. When using a Compules ® Tips Gun, dental professionals and patients should wear
protective eyewear.
2.2 Precautions
1. 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 responsibility of the practitioner.
2. Contact with saliva and blood during composite placement may cause failure of the
restoration. Use of rubber dam or adequate isolation is recommended.
3. Wear suitable protective eyewear, mask, clothing and gloves. Protective eyewear is
recommended for patients.
4. The Esthet•X ® HD Restorative material is a light-cured material. Proceed immediately
once material has been placed on pad or protect from ambient light.
5. Material should extrude easily from the Compules
exerting pressure on the Compules
Excessive pressure may result in unanticipated extrusion of the material or cause the
Compules ® Tip to eject from the Compules
6. Compules ® Tips are designed for one time use. Discard after use. Do not reuse.
7. The Esthet•X ® HD Restorative material Easy•Twist syringe should be tightly closed
immediately after use.
8. Use of Compules ® Tips with the DENTSPLY Caulk Compules
Use with another manufacturer's dispensing device is at the discretion and sole
responsibility of the practitioner. Prior to use, consult the respective manufacturer's
instructions for compatibility, use and sterilization information.
9. Interactions:
Eugenol-containing materials should not be used in conjunction with this product
because they may interfere with hardening and cause softening of the polymeric
components of the material.
2.3 Storage
Esthet•X ® HD Restorative material Compules
discarded after use. Keep out of direct sunlight and stored in a well ventilated place at
temperatures between 2º-24ºC/35º-75ºF. Allow material to reach room temperature prior to
use. Excessive humidity can adversely affect the properties of Esthet•X
material. Protect from moisture. Do not freeze. Do not use after expiration date. The
TruMatch ® Restorative material shade guide should be disinfected by following the
instructions in the Cleaning and Disinfection of the TruMatch
Compules ® Tips Gun should be sterilized by following the instructions in the Sterilization
and Maintenance of Compules ® Tips Gun section. Compules
useful life of one year from date of purchase.
2.4 Adverse Reactions
Product may irritate the eyes and skin. Eye contact: irritation and possible corneal damage.
Skin contact: irritation or possible allergic response. Reddish rashes may be seen on the
skin. Mucous membranes: inflammation, edema, sloughing. See Warnings.
2.5 Technique Tips
1. Esthet•X ® HD Restorative material is a "sculptable," non-sticky, material that resists
slumping and allows the operator to create precise anatomical form.
• When using Esthet•X ® HD Restorative material, it is best not to "spread" the material,
but to "push" or "sculpt" the material.
• It is recommended to dispense/extrude material from a Compules
steady force.
• Rapid and/or forceful extrusion of the material from a Compules
material to appear whitish and/or separated. Upon placement and manipulation,
material will coalesce without compromise in strength or esthetics.
2. Esthet•X ® HD Restorative material was developed to provide the highest surface luster in
order to replicate natural enamel. To achieve maximum polish and maintenance it is
highly recommended to fully complete the polish of Esthet•X
finishing the restoration with Enhance
One Step Diamond Micro-Polisher System and/or Prisma
Pastes.
2.6 Optimizing Shade Selection
1. The opacity of Esthet•X ® HD Restorative material Body Shades has been scientifically
designed to allow the tooth structure enamel and dentin to blend together with the
composite with a life-like translucent result. Additional Opaque and Enamel Shades allow
replacement of each component of lost tooth structure. Layered opacities of material
visually blend to form a restoration with natural vitality and translucence.
® Tip. Use a gentle, even motion when
® Tips Gun. DO NOT USE EXCESSIVE FORCE.
® Tips Gun.
® Tips Gun is recommended.
® Tips are for one time use and should be
® HD Restorative
® Shade Guide section. The
® Tips Gun has an expected
® Tip with a slow,
® Tip may cause
® HD Restorative material by
® Finishing System and polishing with the PoGo
® •Gloss ™ Composite Polishing
®