General Description; Indications And Contra-Indications - DENTAURUM tomas-pin SD Mode D'emploi

Dear customer
Thank you for choosing a quality product from Dentaurum.
It is essential to read these instructions carefully and adhere to them to ensure
safe, efficient use and ensure that you and your patients gain full benefit.
Instructions for use cannot describe every eventuality and possible
application. Should you have any questions or ideas, please contact your local
representative.
As our products are regularly upgraded, we recommend that you always
carefully read the current Instructions for use supplied with the product
and stored in the internet at www.dentaurum.com, even though you may
frequently use the same product.
1. Manufacturer
Dentaurum GmbH & Co. KG I Turnstr. 31 I 75228 Ispringen I Germany

2. General description

A temporary skeletal anchorage option for orthodontic treatment has been
created with the aid of an endosteally anchored mini screw (tomas
The tomas -pin SD and tomas -pin EP have a self-drilling (SD = self-drilling)
® ®
thread (ø 1.6 mm) in different lengths (see point 10). The gingival collar has
a height of 2.0 mm and a maximum ø of 2.8 mm. The head of the tomas
pin SD (Fig. 1) has a cross slot (slot width: 0.56 mm / 22; slot depth: max.
1.15 mm). The tomas -pin EP (Fig. 2) has a mushroom-shaped head. Different
®
orthodontic appliances can be connected to the head of the tomas
according to the indication, to achieve or support the required tooth movement.
tomas ® is a system of coordinated components for the insertion and coupling
of the mini screw.
The tomas -pin is manufactured from a titanium alloy in accordance with AS
®
F 136 and ISO 5832-3. The fracture torque for the tomas

3. Indications and contra-indications

The tomas -pin is used to provide temporary orthodontic anchorage for the
®
following treatments:
• Diastema closure with Class I occlusion
• Distalization and mesialization of teeth
• Uprighting of molars
• Intrusion of teeth
• Sliding mechanics in Class II
• Preventing intrusion of incisor teeth
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• With oligodontia
• Altering the tooth position as part of pre-prosthetic treatment
3.1 General contraindications
The tomas
therapy, blood coagulation disorders, uncontrolled endocrine disorders,
rheumatic ailments, bone system diseases, cirrhosis of the liver or any other
acute illnesses.
3.2 Specific contraindications
The tomas
radiotherapy, recurring oral mucosa diseases or inadequate oral hygiene.
Use is also contraindicated if there is no or insufficient bone availability in
the planned insertion site.
4. Precautions
The tomas
surgeons or maxillofacial surgeons. Before use, operators should ensure that
they have carefully read and followed the instructions for use supplied.
-pin).
®
We recommend operators complete a relevant tomas
working with the pin, as the instructions for use can only cover some of the
many areas of application.
-
®
Only original tomas
for use.
® -pin,
All patients must be examined and given information on the tomas
use.
5. Form of presentation
The tomas
TM
product overview listed under point 10. All other tomas
-pin is 30 Ncm.
®
supplied non-sterile and must be sterilized before initial use. There is one
exception: the tomas
5.1 Sterile pins – tomas
These tomas
blister foil packaging. The packaging should not be removed until shortly
before insertion.
Dentaurum guarantees the sterility of the tomas
on the packaging, provided that the original packaging is undamaged. Once
the time limit has been exceeded, the sterility can no longer be guaranteed and
the tomas
is damaged, do not re-sterilize. Packaging that has been opened may not be
® -pin should not be used in the case of immunodeficiency, steroid
-pin should not be used in the case of osteomyelitis, cranial
®
-pin should only be inserted by orthodontists, dentists, oral
®
® components may be used according to the instructions
-pin is delivered both in sterile and non-sterile form, see the
®
® -punch (gingiva remover) which is sterile on delivery.
-pin SD and tomas
®
-pin versions are delivered sterile, in a glass tube wrapped in
®
-pin may no longer be used on a patient. If the sterile packaging
®
EN
training course prior to
®
® -pin before
components are
®
-pin EP
®
® -pin until the expiration date
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