SURGICAL MANUAL - Microdent System: Expertos en ... · type 1 and 4. The amount of bone must be...

SURGICAL MANUAL

INDEX

PRESENTATION

INTRODUCTION

IMPLANT DESIGN

RAW MATERIALS

MACRO-STRUCTURE

MICRO-STRUCTURE

TECHNICAL FEATURES OF THE PRODUCT

INTRODUCTION

FEATURES

IMPLANT DIMENSIONS

INSTRUCTIONS FOR USE

CONTRA-INDICATIONS

SURGICAL PROTOCOL

CONVENTIONAL SURGICAL PROTOCOL

SURGICAL PROTOCOL WITH THE BONE EXPANSION SYSTEM

MANUAL INSERTION OF THE IMPLANT

MECHANICAL INSERTION OF THE IMPLANT

FITTING THE COVER SCREW FOR FIRST SURGERY

IMPLANT PACKAGING

PACKAGE PRESENTATION

PACKAGE FEATURES

GUIDANCE ON THE OPENING OF THE CONTAINER

LABELING CODE SYMBOLOGY


MRI SAFETY INFORMATION

SURGICAL INSTRUMENTS

GUARANTEE PROGRAM

CHART OF MICRODENT EKTOS INSTRUMENTS

Pag. 05

Pag. 06

Pag. 07

Pag. 15

Pag. 17

Pag. 17

Pag. 18

Pag. 18

Pag. 12

Type of raw material

Composition table

Previous considerations

Recommended sequence

Technical features

Usage features

Relative contra-indications

Local contra-indications

Recommendations of the insertion sectors

Other recommendations

Surface

External shape features/characteristics (shape and thread type)

Connection

PRODUCT STORAGE PRECAUTIONS

PRESENTATION

Implant Microdent System S.L. is a company that, from its creation in 1983, has specialized in developing, manufacturing and marketing components for odontological treatments, and, specially, oral implantology.

Always striving for customer satisfaction, Microdent offers all the guarantee, both of quality and service, backed up by its long and ascending professional history in the field of oral implantology.

The periodical offer of formation courses for professionals of the implantology field and the existence of a collaboration and assessment team allows Microdent to have products that verify the most strict quality parameters stablished, as well as to satisfy the needs of its clients.

Microdent has modern facilities equipped with the most cutting-edge technology, thus making Microdent into one of the pioneer companies in the research and manufacture of solutions for oral implantology. The patents obtained by Microdent products demonstrate the continued dedication of the company to the research work.

MICRODENT EKTOS SURGICAL MANUAL 5

INTRODUCTION

IMPLANT DESIGNThe internal connection Microdent Ektos implant system has been designed and conceived to facilitate and to solve the important medical work of practitioners, who require high quality materials.

RAW MATERIALS• Type of raw material The raw material used in the manufacture of Microdent implants is Titanium grade 4, in compliance with the ISO 5832 standard, thus confirming its suitability for use in the manufacture of dental implants.

All the raw material received by Implant Microdent System is acquired from suppliers of established standing and proven experience. To ensure this level of requirement, all material received is accom-panied by the proper composition analysis and mechanical performance certificates issued by the manufacturer.

• Composition tableThe material composition must be consistent with the ISO5832-2:1999 standard “Implants for surgery – Metallic materials – Part 2: Unalloyed Titanium”, as described in the following table:

Material type

Titanium Gr4

Limits in the material composition (% in relation to the mass)

Microdent Ektos With internal hexagonal connection

0.5 max 0.4 max 0.1 max 0.05 max 0.0125 max

MICRODENT EKTOS SURGICAL MANUAL6

MACRO-STRUCTURE • External shape features/characteristics (shape and thread type)The threaded contour of the Microdent Ektos implant is characterized by presenting auto-thread and a broad thread step.

• ConnectionThe Ektos implant has an internal hexagonal connection.

MICRO-STRUCTURE • Surface The Ektos implant surface is treated with aluminum oxide (sandblasting).

It consists of two phases:

1. In the first phase, the implant is subjected to a projection of particles in a sealed room, with regulated and controlled pressure. This process increments the implant total outer surface.

2. In the second phase, the implant is subjected to a washing and decontamination process.

Image 1: ATEC (Abrasive Treatment Extreme Cleaning) surface treatment

TECHNICAL FEATURES OF THE PRODUCT

INTRODUCTIONThe Microdent Ektos dental implant is an internal hexagonal connection endosseus implant. This implant is inserted at supracrestal or bone level position, along with the rest of the general rehabilitation.

The connection design has a conical socket which ends in a cylindrical section.

MICRODENT EKTOS SURGICAL MANUAL

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Image 3: detail of a supracrestal insertion

Image 2: product technical features

Includes multifunction abutment. It allows to take impressions around the abutment itself and, depending on the type of treatment, it can be used as a permanent abutment

ATEC (Abrasive TreatmentExtreme Cleaning) surface treatment

Anatomical theaded profile to facilitate primary retention

Biological sealed

Double entry externalthreading thatallows the numberof turns requiredfor the insertion ofthe implant to beshortened

Rounded implant tip to minimize injury in the sensitive anatomical structures

FEATURES Technical features• Designed to adapt to different bone types.• 2.1mm Thread step • Auto-thread screw • It is recommended to place the Microdent Ektos Implant at crestal bone level or 1mm on supracrestal position.

Usage features • VersatileThe Ektos system has a broad range of implants to answer to different implantological situations.

• SatisfactionMore than 30 years of experience guarantee implant osseointegration.


8mm 10mm 12mm 14mm 16mm

EK58

08CP

EK58

10CP

EK58

12CP

EK58

14CP

EK58

16CP

8mm 10mm 12mm 14mm 16mm 18mmLength

Platform Ø 4.5 / Core Ø 4.8

EK48

08CP

EK48

10CP

EK48

12CP

EK48

14CP

EK48

16CP

EK48

18CP


18mm 16mm 14mm 12mm 10mm 8mm8mm 10mm 12mm 14mm 16mm 18mmLength


EK37

08CP

EK37

10CP

EK37

12CP

EK37

14CP

EK37

16CP

EK37

18CP

EK42

18CP

EK42

16CP

EK42

14CP

EK42

12CP

EK42

10CP

EK42

08CP


Length

IMPLANT DIMENSIONSThere are four models of Microdent Ektos implants. Each model is characterized by a platform size (there is a total of three different sizes 3.5, 4.5 and 5.7mm) and a diameter core.

The different lengths available for each model are shown below:


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Indicated for single and multiple fixed rehabilitations on premolar and molar groups.Indicated for rehabilitation of edentulous patients.For multiple structures, it is recommended to use in combination with other larger diameter implants.

Platform Ø 3.5 / Core Ø 4,2

Indicated for single and multiple fixed rehabilitations on canines and premolars.Indicated for rehabilitation of edentulous patients.For multiple structures, it is recommended to use in combination with other larger diameter implants.


Indicated for single and multiple fixed rehabilitations of the previous group.Indicated for rehabilitation of edentulous patients.For multiple structures, it is recommended to use in combination with other larger diameter implants.


The Microdent dental implants are indicated to be surgically placed into the maxilla and/or mandible to provide support for the dental prosthesis. They are indicated for dental rehabilitation of partially or totally edentulous patients, for support and retention of single crowns, bridges or overdentures. The minimum age for placement of dental implants depends on the completion of an individual’s growth. When a person has completed their development, they will be able to enjoy the benefits of dental implants, it is not recommended before that point. There is no maximum age for dental implant treatments.


Indicated for single and multiple fixed restorations on molar areas.Indicated for rehabilitation of edentulous patients.

Recommendations of the insertion sectors (Clearest zones)


Other recommendations

The ideal distance between an implant and a tooth is 1.5 mm or more. Between implants, the recomended distance is 3mm or more (see image 4).

Small diameter implants are indicated only for replacement of central and lateral incisors in the maxilla and mandible.

Small diameter implants and angled abutments are not recommended for the posterior region of the mouth.

CONTRA-INDICATIONS

As in any surgery, everything that endangers or might endanger the osseointegration of the implant has to be evaluated in order to minimize the implant placement risk.

Serious internal medicine problems, bone metabolism disorders, uncontrolled coagulation disorders, uncooperative or unmotivated patients, alcohol or drug abuse, psychosis, long-time treat-ment-resistant functional disorders, xerostomia, weakened immune system, diseases with a regular use of steroids, titanium allergy, non-controllable endocrine diseases.

Relative Contra-indications:

Previously irradiated bone, diabetes, anticoagulant medication / hemorrhagic diabetes, bruxism, para-functional habits, unfavorable bone anatomy, smoking, uncontrolled periodontitis, jaw diseases and disorders of the oral mucosa susceptible of treatment, pregnancy, inadequate oral hygiene.

Local Contra-indications:

Insufficient available bone or inadequate bone quality, local root fragments.

PRODUCT STORAGE PRECAUTIONS

The dental implant, once packaged, does not require special storage conditions. The package only requires to keep its integrity and incorruptibility. It can be stored under normal conditions of temperature and humidity.

The packaging system guarantees, according to aging tests conducted in compliance with ASTM F1980, the sterile state of the implant for five years from the date of packaging.

Image 4: detail of implant-tooth and implant-implant distance


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SURGICAL PROTOCOLThere are two different surgical protocols, the conventional protocol and the atraumatic expansion protocol. In the first, the alveolus preparation is performed through a drilling sequence, while in the second it is prepared through the employment of Microdent Expanders.

CONVENTIONAL SURGICAL PROTOCOLPrevious ConsiderationsAppropiate radiographic pre-operative analysis is necessary to determinate the position of any impor-tant anatomical structure.

Microdent Ektos implants can be placed with the flap lifted to directly visualize the bone bed or without a mucoperisoteal incision by using circular scalpels.

The drilling sequence will be determined by the bone quality of the patient, being different in a bone type 1 and 4. The amount of bone must be evaluated based on technical and radiological images used in implantology. The needed instruments for drilling are sharp instruments that require constant irrigation.

The Microdent Ektos implant is designed for supracrestal placement. The nominal length of the implant is defined from the platform to the apical area of the implant.

Microdent surgical instruments for drilling are part of an overall concept. Their design has been adapted to products manufactured by Implant Microdent System S.L., therefore, the use of surgical instruments from other trademarks might cause a non-optimal performance of our products.

The surgical instruments for drilling have to be cleaned and sterilized before being used in another patient.

The surgical drills are indicated for 10-20 uses. To exceed these number of uses may compromise the success of the treatment.

When using drilling surgical instruments, it is mandatory to properly irrigate in order to avoid bone over-since it that could cause failure of the implant.

The marketed Implant Microdent drills have an irrigation system that diminishes bone heating during the surgical process.

Recommended sequenceThe drilling sequence varies according to the implant diameter. Below, the drilling protocols for each of the Ektos implant series are shown.

Image 5: Microdent Ektos implant with multifunction abutment

Implant 3.5 Platform Surgical Protocol

3.7 Core Procedure

Reference

Drilling speed (RPM)

FP1812/ FP1817 F280/F300F250FC20

400-800400-800800-1200800-1200


4.8 Core Procedure

4.2 Core Procedure


Reference


Reference


FP1812/ FP1817

FP1812/ FP1817

F350/F380F320

F320/F350

F250/F280

F250/F280

FC20

FC20

300-500400-800

400-800

400-800

400-800

800-1200

800-1200

800-1200

800-1200


5.8 Core Procedure

Reference


FP1812/ FP1817 F450/F510F350/F380F250/F280FC20

300-500400-800400-800800-1200800-1200


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SURGICAL PROTOCOL WITH THE BONE EXPANSION SYSTEM

The alveolar osteotomy can also be prepared with Microdent atraumatic expanders, specially in cases of narrow bone crest or when a better use of the patient’s bone support is desired (see manual expansion at www.microdentsystem.com).

Expansors description and main features

EXPANDER #1 EXPANDER #2 EXPANDER #3 EXPANDER #4 EXPANDER #5 EXPANDER #6

INITIAL SHORT

Ø TIP 1.00mm to 2.30mm

INITIAL LONG


EXPANDER


EXPANDER


EXPANDER


SINUS

STRAIGHT

Ø 3.50mm

LONG. 10mm LONG. 16mm

8mm=Ø 2.75mm 10mm=Ø 3.00mm

12mm=Ø 3.25mm 14mm=Ø 3.50mm

YELOW COLOR

RED COLOR

LIGHT BLUE COLOR

GREEN COLOR

DARK BLUE COLOR

8mm=Ø 3.40mm10mm=Ø 3.70mm12mm=Ø 4.00mm14mm=Ø 4.30mm

8mm=Ø 3.90mm10mm=Ø 4.20mm

FOR IMPLANTSØ 4mm

12mm=Ø 4.50mm14mm=Ø 4.80mm

Ø 4.20mm

ELEVATOR

MANUAL INSERTION OF THE IMPLANT

Insert the implant into the osteotomy and begin fixing the implant by turning it clockwise. If during the insertion of the implant in the osteotomy (on the first threads) it is necessary to apply more force than usual, it is recommended the removal of the implant from the alveolus and increasing its size with a larger burr. Forcing in the implant could cause damage.

Once the implant is 2/3 inserted in length, finish the insertion by using the extension adaptable to the multifunction abutment (reference PMFLLID) and if this is not possible due to particular space conditions, remove the metal implant holder with the aid of a screwdriver (MH120) and finish the insertion process using the corresponding adaptor.

It is advised the use of an insertion torque not greater than 40 Ncm. To control the torque, the torque-measuring ratchet (reference LDR2070) is recommended.

MECHANICAL INSERTION OF THE IMPLANT

If the implant is to be inserted using a micromotor, insert the adaptor (reference PMFLLIC) that was previously fitted to the hand piece, over the metal implant holder.

To extract the implant from the plastic support, press the support lightly in the direction of the opening where it is housed.

Move the implant to the osteotomy and proceed to insert it, regulating the speed of the micromotor to obtain maximum control over the process.

We recommend using an insertion torque not greater than 40 Ncm.


FITTING THE COVER SCREW FOR FIRST SURGERY

The cover screw is housed in the transport cap on the opposite side to the implant.Both implant and cover screw are presented in a sterile condition.

Once the implant has been inserted into the osteotomy, remove the cover screw from the plastic cap using screwdriver (MH120C) by turning it gently counterclockwise.

Carefully take it to the implant, insert it and screw in the accessory by turning it clockwise.It is advised the use of an insertion torque of 5 Ncm.Proceed to stitch the soft tissue.

IMPLANT PACKAGING

PACKAGE PRESENTATION

Microdent’s packaging system is designed to be easy and simple to use. All containers are decorated with the distinctive color of the corresponding implant system, being purple the color chosen for the Microdent Ektos implant system.

The rectangular design and the small size of the box allows an easy storage, minimizing the need for space.

Inside the package, two identification labels accompany the implant.In the secondary container, the web address to visit the instructions for use is indicated.

PACKAGE FEATURES

The implants from the Microdent Ektos series are presented in a sterile condition.The implant, which carries a multifunction abutment, is mounted on a plastic support.The plastic cap hosts the cover screw.

The container maintains its sterility by a metallic sealing cap. The protection of this sterile barrier system is achieved by a threaded cap with precint that closes the outer package and does not allow the manipulation of the content.

Both the outer packaging and the inner packaging have a label with the following information: batch number, size and model of the implant and expiration date.

To realize the correct monitoring of the obliged traceability of these products, the labels have to be included in the patient’s file.

Images 6: primary packaging of a Microdent Ektos implant


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GUIDANCE ON THE OPENING OF THE CONTAINER

Before opening the package, perform a visual check to ensure that it has not been damaged.

Instructions for use packaging

Open the implant threaded cap counter-clockwise.

Remove the aluminum cap from the container by the flap.

Once the cap has been removed, extract the implant’s container. The plastic cap contains the cover screw.

Remove the plastic cap from the container.

Remove the implant with the manual key for multifunction abutment.

Insert the implant into the opening using the manual key for multifunction abutment.

Remove the implant with the contra angle key for multifunction abutment.

The implant can also be taken into the patient’s mouth with the handpiece using the contra angle key for multifunction abutment.

Image 7: secondary packaging of a Microdent Ektos implant


INSTRUCTIONS FOR USEIn accordance and compliance with legal requirements, all implants manufactured by Implant Microdent System have instructions for use. These instructions are available at www.microdentsystem.com

Sterile by irradiation

Device IdentifierUnique DeviceIdentifier (DI&PI)

Endosteal diameter

Lot/batch number

Site for Instructions or Use (IFU) review

Do not use if package is damaged

Expiration date

Reference/article number

Caution: federal law restrics this device to sale by or on the order of a dental professional

Implant type

Do not re-use

Caution, consult accompanying documents

Manufacturer

LABELING CODE SYMBOLOGY

MRI SAFETY INFORMATIONImplants and abutments have not been evaluated for safety and compatibility in the MR environment. Implants and abutments have not been tested for heating, migration, or image artifact in the MR environment. The safety of implants and abutments is unknown. Scanning a patient who has this device may result in patient injury.

SURGICAL INSTRUMENTSFor a proper use and cleaning of surgical instruments, consult their instructions for use.


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GUARANTEE PROGRAM Implant Microdent System provides guarantees for the products it distributes. The terms and conditions of these guarantees are indicated in the Microdent Implant System “Guarantee Program”, consult their instructions for use: www.microdentsystem.com

CHART OF MICRODENT EKTOS INSTRUMENTSMaterial instruments: Stainless steel

1025Expander #1

2938Expander #3

4452Expander #5

1830Expander #2

3345Expander #4

3535Sinus elevator

EXPANDERS

FC20CCortical dfrill (short)

FP1812Pilot drill (short)

F250CSurgical drill

Ø 2.50mm (short)

FC20LCortical dfrill (long)

FP1817Pilot drill (long)

F250LSurgical drill

Ø 2.50mm (long)

DRILLS

Drill stops also available

6mm

10mm

14mm

18mm

8mm

12mm

16mm


DRILLS

Drill stops also available

F280CSurgical drill

Ø 2.80mm (short)

F300CSurgical drill

Ø 3.00mm (short)

F320CSurgical drill

Ø 3.20mm (short)

F280LSurgical drill

Ø 2.80mm (long)

F300LSurgical drill

Ø 3.00mm (long)

F320LSurgical drill

Ø 3.20mm (long)

F350CSurgical drill

Ø3.50 mm (short)

F380CSurgical drill

Ø 3.80mm (short)

F420CSurgical drill

Ø4.20mm (short)

F350LSurgical drill

Ø 3.50mm (long)

F380LSurgical drill

Ø 3.80mm (long)

F420LSurgical drill

Ø4.20mm (long)

F450CSurgical drill Ø4.50 mm

F510CSurgical drill Ø5.10 mm

6mm

10mm

14mm

18mm

8mm

12mm

16mm

6mm

10mm

14mm

18mm

8mm

12mm

16mm

6mm

10mm

14mm

18mm

8mm

12mm

16mm


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SCALPELS

OTHER TOOLS

BC560LScalpel Ø 5.60 mm

(long)

EKLLIC35/EKLLIC45/EKLLIC57

Contra-angle insertion key

EKAF35C/ EKAF45C/EKAF57C

Extender (short)


(long)

DC120HLHex. 1.20 contra-angle

screwdriver

MH120CHex. screwdriver 1.20mm (short)


(long)

PMFLLICContra-angle key for

multifunction abutment

LDR2070Torque measuring

ratchet

BC560CScalpel Ø 5.60 mm

(short)

DL120HLHex. 1.20 ratchet

screwdriver

EKAF35L/ EKAF45L/EKAF57L

Extender (long)


(short)

PMFLLIMManual key for multi-

function abutment

MH120LHex. screwdriver 1.20mm (long)


(short)

PMFLLIDRatchet key for multi-

function abutment

X-ray templates (plastic film) also available. Part Number PPQEK

SURGICAL MANUAL


SURGICAL MANUAL

SURGICAL MANUAL - Microdent System: Expertos en ... · type 1 and 4. The amount of bone must be...

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