Komet ER Denin Post X Series Instructions For Use

Manufacturer:
Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25
32657 Lemgo · Germany
ER DentinPost X
© 03/2014, Gebr. Brasseler GmbH & Co. KG
304850 - Rev 03/2014
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¿ Order number
Numéro d'ordre
Número de pedido
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Post systems
Systèmes de reconstitution
Sistemas de postes
Fig. 1 Fig. 2
Size Colour: yellow
Taille Couleur: jaune
050
Tamaño Color: amarillo
Pilot drill · Foret pilote · Fresa piloto
1.000 - 5.000 rpm
(
183LB.204 20.000 rpm
)
Reamer · Elargisseur · Ensanchador
1.000 - 2.000 rpm
(
196.204
20.000 rpm
)
Reamer, long · Elargisseur, long · Ensanchador, largo
1.000 - 2.000 rpm
(
196L.204 20.000 rpm
)
Depth gauge · Calibre de profondeur · Calibre de profondidad
45L9
Planschleifer · Root facer · Alésoir à surfacer · Abrasivo para planear · Spinaradici diamantata
2.000 rpm
(
120D.204.030 ) 20.000 rpm
Roughening instrument · Instrument à rugosifier · Asperizador
196D.644
ER Dentin Post X
= 443L9
= 443L12
Tab. 1
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ER DentinPost X for restoration of teeth with plastic materials
1. System overview
see table 1
2. Indication
Prosthetic reconstruction of teeth with destroyed crown. General requirements:
- wall adaptation of the post along its entire length
- the lower retention element (up to the first retention groove) can be countersunk in the root cross-section
- endodontic treatment completed successfully
3. Contraindications
- With cervical funnel-shaped canal lumen, wall adaptation of the post along its entire length is not possible.
- The lower retention element (up to the first retention groove) cannot be countersunk in the root cross-section.
- subgingival caries
- circular isogingival destruction
- Full circular embrace of the post in natural, sound hard substance is not possible.
4. Clinical sequence/proper use
4.1 General preparatory procedure:
- the tooth/root has been prepared endodontically according to the indication.
- endodontic treatment has been completed
- sealing of the apical third
- select post corresponding to the tooth to be restored considering the clinical situation
- by means of radiograph, determine the post diameter and length according to the anatomic situation of the
tooth
- post should end app. 3 – 5 mm short of the apex.
- for stability reasons, post has to adapt to the wall and has to be anchored in the root canal as deeply as
possible (at least 2⁄3 of the post length)
- removal of the root filling app. 3 – 5 mm short of the apex using pilot drill 183LB.
- selected post size 050, 070, 090 or 110
- by means of a stop, mark the required preparation length on the pilot drill (Fig. 1)
- establishing the central inlay cavity (maximum depth 1 – 2 mm)
- for antirotational enhancement and stabilization, prepare a longitudinal oval tapered auxiliary cavity (Fig. 2)
- by slightly inclining the root facer
- with root facer 120D.204.030
- prepare inlay cavity with antirotational groove (Fig. 3)
- with cylindrical diamond grinding instruments, e.g. 835KR
- enlarge root canal corresponding to the selected post
- using the corresponding enlarger 196 (Fig. 4)
- apply depth measuring gauge 45L9 or 45L12 matching the root post to the enlarger
- enlargement should be carried out in an intermittent way with minor pressure until required depth is reached
- in the meantime the root canal should be rinsed and the reamer should be cleaned with brush 9791
- preferably enlarged manually
- clean and dry root canal
- check precision fit of the prepared post site by inserting selected post
- eliminate irregularities, if any, with enlarger 196
- If necessary, take a radiograph for control
- the ER DentinPost X is radiopaque (but the contrast is not as pronounced as with ceramic or metallic posts)
4.2 Insertion of post and reconstruction
4.2.1 Mechanical conditioning of the canal wall with roughening instrument 196D:
- Turn instrument manually in the root canal without applying pressure (3 – 5 turns) (Fig. 5)
4.2.2 Rinse root canal and inlay cavity and dry:
- with sodium hypochlorite (NaOCl) for disinfection
- with ethylenediaminetetraacetic acid (EDTA) or citric acid for removing the smear layer (additional rinsing with
NaOCl)
- dry with paper points
- cleaning the post surface: degrease with medical alcohol and dry by means of air jet
- the post is cemented using the adhesive technique
Distributor/Importer for USA and Canada:
Komet USA LLC
3042 Southcross Blvd, Suite 101
Rock Hill, SC 29730, USA
Phone: 888-566-3887
Fax: 800-223-7485
info@kometusa.com
www.kometusa.com
CAUTION: U.S. Federal law restricts the device
to sale by or on the order of a licensed dentist.
| LOT number
Numéro de lot
Número de lote
=
Do not re-use! (single use only)
Ne pas réutiliser (usage unique)
No reutilizar (un solo uso)
Fig. 3
Size Colour: orange
Taille Couleur: orange
070
Tamaño Color: naranja
1.000 - 5.000 rpm
(
183LB.204 20.000 rpm
)
1.000 - 2.000 rpm
(
196.204
20.000 rpm
)
1.000 - 2.000 rpm
(
196L.204 20.000 rpm
)
45L12
196D.644
= 444L9
= 444L12
Instructions for use
Please read carefully and retain for future reference.
Conseils d'utilisation
A respecter scrupuleusement et garder cette copie
pour une utilisation ultérieure.
Instrucciones de empleo
Leer detenidamente y guardar este ejemplar para
uso más tarde.
?
Consult instructions for use
Se reporter aux instructions
Observe indicaciones
Fig. 4 Fig. 5
Size Colour: red
Taille Couleur: rouge
090
Tamaño Color: rojo
1.000 - 5.000 rpm
(
183LB.204 20.000 rpm
)
1.000 - 2.000 rpm
(
196.204
20.000 rpm
)
1.000 - 2.000 rpm
(
196L.204 20.000 rpm
)
196D.644
= 445L9
= 445L12
- chemical conditioning of the dentin with bond-assisting agent (e.g. ED Primer
manufacturer's instructions
- coat post with self-curing or dual-curing composite (e.g. Panavia
- insert post slowly into the root canal with moderate pressure so that excessive cement can escape and fixate
by finger pressure.
- let composite polymerize and remove excessive material, if necessary.
4.2.3 Completing the definite preparation
- Adaptation of plastic buildup material (e.g. Clearfil Core
(Fig. 6)
- Curing and completing the definite preparation (Fig. 7)
- For the definite preparation, please observe the following rules
- Core has to be surrounded circularly
- For all-ceramic crowns a shoulder preparation is indicated- The crown has to surround the post
reinforced root in an at least 2 mm parallel zone so that forces are
distributed on the entire tooth
5. Further treatment
- Impression and temporary restoration
- Fabrication a placement of crown
6. Recommendations for maintenance
- All system components are supplied in non-sterile condition.
- Attention: the ER DentinPost X cannot be sterilized. Therefore, they must be cleaned and disinfected with
medical alcohol. Root posts are single-use products. The reuse of these products poses a risk of infection and/
or the safety of the products can no longer be guaranteed.
- Instrument preparation prior to each use: Cleaning, Disinfection and Sterilization
- The instruments are to be treated with anticorrosive disinfecting and cleaning agents suited for rotary
instruments. Regarding recommendation for use (immersion time, concentration, suitability) of the disinfect ing
or cleaning agents see manufacturers' instructions. Thoroughly remove all residues of disinfecting and cleaning
agent with water and allow to dry completely (e.g. by means of air stream). Do not store instruments in wet or
humid condition for a prolonged period of time. Make sure that instruments do not come in contact with each
other during ultrasonic cleaning. Inspect cleaned instruments visually. Any damaged or blunt instruments are to
be rejected and must no longer be used. Sterilization of the instruments is carried out using the known methods
in the autoclave accord ing to the specific provisions on the sterilization of medical products in your country. The
instructions of the respective device manufac turer have to be observed. After sterilization, check instruments for
defects on the surface. Corroded instruments must not be used any longer.The operator of medical products is
responsible for seeing that proper treatment is carried out by qualified personnel using the appropriate materials
and suited equipment.
7. Safety and liability
See also "Instructions for use and safety recommendations" in the Komet USA LLC catalog and our website at
www.kometusa.com. The user is responsible to check the products prior to use whether they are suited for the
intended purpose. DentinPost X posts are part of the ER root post system and should only be used with the
corresponding original instruments according to these instructions. The manufacturer declines any liability or
compen sation for possible damage due to the use of instruments which do not belong to the system and which
may impair the function.
8. Disclaimer of Warranties
ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE EXPRESSLY
DISCLAIMED. ALL INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOST
PROFITS, INJURY TO OTHER PROPERTY, LOSS OF USE OR OTHER COMMERCIAL LOSSES, ARE EXPRESSLY
DISCLAIMED. If, not withstanding the foregoing, consequential and incidental damages cannot be excluded
due to operation of law, such damages are expressly limited in amount to the purchase price of any defective
products.
Store out of children's reach.
For dental use only.
Packing unit
/
Unité d'emballage
Unidad de embalaje
Fig. 6
Size Colour: blue
Taille Couleur: bleu
110
Tamaño Color: azul
1.000 - 5.000 rpm
(
183LB.204 20.000 rpm
)
1.000 - 2.000 rpm
(
196.204
20.000 rpm
)
1.000 - 2.000 rpm
(
196L.204 20.000 rpm
)
196D.644
= 446L9
= 446L12
F, Kuraray or RelyX
®
, Kuraray) according to the manufacturer's instructions
®
Fig. 7
Material
Matériau
Material
Stainless Steel
Acier inoxydable
Acero inoxidable
Stainless Steel
Acier inoxydable
Acero inoxidable
Stainless Steel
Acier inoxydable
Acero inoxidable
Stainless Steel
Acier inoxydable
Acero inoxidable
Stainless Steel · diamond coated
Acier inoxydable · diamanté
Acero inoxidable · diamantado
Stainless Steel · diamond coated
Acier inoxydable · diamanté
Acero inoxidable · diamantado
Glass-fibre reinforced composite
Composite renforcé de fibres de verre
Composite reforzado por fibras de vidrio
, Kuraray) according to the
®
Unicem, Espe)
TM