ORALLOY MAGICAP S Gebrauchsinformation ... - Elident Group

Instructions for use (English)
ORALLOY MAGICAP S
Definition
Coltène® ORALLOY MAGICAP S is distributed in predosed
capsules which contain mercury in the foil bag
and a ternary, microcrystalline, spheroidale alloy powder
for the fabrication of NON-GAMMA-2 amalgams.
Mixing alloy powder with mercury produces a sculptable
paste that sets within a short period of time.
Its effectiveness lies in its ability to durably replace
lost tooth structure and restore masticatory function.
Composition
1 capsule contains: 1 spill 2 spills 3 spills
(green) (blue) (red)
Ag elementary 0.24 g 0.36 g 0.48 g
Sn elementary 0.11 g 0.16 g 0.21 g
Cu elementary 0.05 g 0.08 g 0.11 g
Alloy 0.40 g 0.60g 0.80 g
Hg elementary 0.34 g 0.51 g 0.70 g
Amalgam 0.74 g 1.11g 1.50 g
Mixing ratio: 1 : 0.9 1 : 0.9 1 : 0.9
Field of application
Occlusion-bearing restorations in the posterior area
(class I and II), if no other plastic restorative materials
or techniques may be applied.
Contraindications
Amalgam should not be used:
– In case of allergic reaction to the components of
Coltène® ORALLOY Tablets or materials of amalgam
of similar composition.
– No new amalgam restorations should be placed in
patients suffering from severe kidney disfunction.
– For retrograde root canal fillings.
We recommend not to carry out extensive amalgam
therapy (placement and, in particular, removal of
amalgam fillings) during pregnancy.
Small children exhibit increased sensitivity to mercury
and it should be evaluated with utmost care, it amalgam
restorations are necessary.
Side effects
Allergic reactions of type IV and/or electro-chemical
reactions (e.g. taste sensations and irritations of the
mucous membrane) have been researched to occur
only in individual cases.
Electro-chemical processes may provoke the lichen
planus of the oral mucosa.
After the placement or removal of amalgam fillings, a
slight increase of the mercury concentration in the
blood or the urine can be observed for a limited period
of time.
Interactions
Amalgamation and subsequent electro-chemical reaction
may occur when unset silver amalgam or, in
particular, mercury pressed out during condensation
comes into contact with gold or other precious metal
(restorations or dentures).
Contact of the occlusal or any lateral surface with adjacent
crowns, bridges, inlays or fillings made of different
alloys may lead to galvanic effects (caused by
corrosion).
If local missensations (e.g. taste sensations) due to
electro-chemical reactions upon contact of the amalgam
filling with other alloys should occur and continue
for a certain time, the amalgam filling should be
replaced using a different material.
Application
Dosing
The mixing ratio predetermined by the amount of alloy
and mercury contained in the capsules should be
observed. Predosed capsules are available.
Mixing/trituraton
Coltène® ORALLOY MAGICAP S are self-activating.
This means that the capsules are inserted into an appropriate
mixing device. Before initiating the trituration
process, check the fit of the capsule. The trituration
time has to be set individually for each device
(deviations in time, frequency and amplitude can be
observed even in devices of the same type). The result
of an ideal trituration time is an amalgam bead with a
silvery gloss which comes off the capsule cleanly. Too
long trituration times result in sticky amalgam (especially
on the foil of the mercury pillow) and reduced
working time. Too short trituration may lead to a dull
appearance and insufficiently mixed material.
Trituration time for the predosed capsules
Coltène® ORALLOY MAGICAP S in seconds.
Instrument Speed 1 Port. 2 Port. 3 Port.
Capmix fixed 5 – 7 5 – 7 5 – 7
Silamat fixed 5 – 7 5 – 7 5 – 7
Silamat Plus Programm P2 5 – 7 5 – 7 5 – 7
(slow) (fast) (slow)
Vari-Mix Mll M2 8 – 12 8 – 12 8 – 12
Dentomat 4’000 – 4’500 5 – 7 5 – 7 5 – 7
Duomat 4’000 – 4’500 5 – 7 5 – 7 5 – 7
Automix Tytin reg. 400 mg 600 mg 800 mg
Dry oral environment
Before applying the amalgam, take the necessary precautions
to ensure a dry environment (e.g. use Hygenic®
Dental Dam).
Cavity lining
Dentin and pulp should be protected against infiltration
using appropriate materials.
Matrix
In order to be able to adequately condense the amalgam
in approximal cavity areas, the use of a suitable
matrix system is strictly necessary.
Condensing characteristics
Apply small portions to fill the cavity in an optimal
way. Start with small, flat and smooth condensers.
Progressively use bigger condensing instruments the
closer you get to the occlusal surface and overfill the
cavity generously. By burnishing the restoration before
carving, the amalgam is condensed and homogenized.
The use of mechanical and pneumatic condensing
instruments is recommended.
Working time: 2´00´´ – 2´30´´
Setting Time: 2´30´´ – 5´30´´
Carving
Carving can be done immediately after the removal of
the matrix. You may use any suitable, sharp carving instrument.
The cuttings that result must be aspirated
immediately. By burnishing the restoration before
carving, the amalgam is condensed and homogenized.
Polishing
Every amalgam filling must be polished. This should
be done at the earliest 24 hours after placement. Polishing
of amalgam fillings should always be done under
profuse water cooling. To avoid generation of
heat during polishing, the rotating instrument should
be run at the lowest possible speed.
Appropriate precautionary measures when removing
amalgam restorations, such as using aspirator, rubber
dam, water spray, keeping the operatory ventilated,
disposing of amalgam residues according to prescriptions
etc, will reduce any danger to the health of
patient and surgery staff due to possible exposure to
mercury.
Note
Keep out of the reach of children!
Should not be used after expiry date.
Only supplied to dentists and dental laboratories or
upon their instructions.
Storage
15–23 °C / 59–73 °F.
Special storage recommendations
Any danger to the health of dentist and surgery staff
by mercury vapours can be avoided by handling mercury
and amalgam correctly during mixing, by storing
the amalgam residues immersed in fixing solution in
firmly sealed containers and by keeping the operatory
ventilated.
Local waste management prescriptions should be followed.
Shelf life and marking
Storage
Coltène® ORALLOY MAGICAP S fulfills the intended
purpose until the expiration date, which is displayed
on the product or packaging.
Marking
The number is visible on the package.
Technical data
Compressive strength
After 1 hour 200 MPa
After 24 hours 470 MPa
Dimensional stability + 0.03 %
Creep
after 7 days: 0.15 %
Caution
Federal law restricts this devise to sale by or on the order
of a dentist.
Date of issue
April 2010
Coltène/Whaledent AG
Feldwiesenstrasse 20
9450 Altstätten/Switzerland
Tel. +41 (0)71 757 53 00
Fax +41 (0)71 757 53 01
info@coltenewhaledent.ch
For MSDS see
www.coltenewhaledent.com