Dental Implants

Não utilizar se a embalagem estiver danificada

No usar si el paquete está dañadoDo not use if package damaged

Manter secoMantenga seco

Keep dry

Não reesterilizarNo reesterilizar

Do not resterilize

Produto esterilizado por radiação gamaProducto esterilizado por radiación gama

Product sterilized through gamma rays

Manter afastado do solMantener fuera de la luz solar

Keep away from sunlight

Consulte as instruções de utilizaçãoConsulte las instrucciones de utilización

Refer to instructions for use

Prazo de ValidadeFecha de FabricaciónDate of Manufacture

Código do ProdutoCódigo del Producto

Product Code

Número do LoteNúmero de Partida

Batch Number

Data de FabricaçãoFecha de FabricaciónDate of Manufacture

FabricanteFabricante

Manufecturer

0434

Representante europeu autorizadoRepresentante europeo autorizado

Authorised representative in the european comunity

Marcação CE para Comercialização na Comunidade EuropéiaMarca CE para Comercialización em la Comunidad Europea

CE Mark for European Community Market

0434

Bionnovation Produtos Biomédicos LTDA.Rua Laureano Garcia, 1-275 –CEP: 17039-760 Bauru - SP • Fone 55-14 4009 2400 • SAC 0800 770 3824CNPJ 73.191.090/0001-19 • IE 209.444.766.117Resp. Técnico: Roselaine dos Santos Pinto Marques - CRQ-IV 04488952MADE IN BRAZIL / INDÚSTRIA BRASILEIRA / INDUSTRIA BRASILEÑA

www.bionnovation.com.br

Bionnovation Biomedical A.B.Welandergatan 24S-41656 Gothenburg SwedenPhone 0303773325

Bula INQ001 rev017/02-10-2015

DESCRIPTION AND ACTION FOUNDATIONSOsseointegrated implants are devices inserted into bone tissue of mandible or jawbone of totally or partially edentulous patients to replace the roots of missing teeth. On such devices single or multiple dental prostheses are fixed.Titanium, the raw material of implants, is a biocompatible and non-cytotoxic material. Titanium naturally produces a layer of oxides able to attract cells from adjacent tissue that are induced by such physical-chemical process and tend to deposit on the outer layer of metal, thus fixating the implant to the bone tissue and allowing for the application of implant-supported prosthesis. Bionnovation implants have their surface treated with acid corrosion known as Supex. Supex treatment provides a wrinkled texture to metal, thus facilitating the migration of bone cells and increasing the contact area between the implant and the bone tissue, which optimizes the osseointegration process.The family of Bionnovation Classic odonthological implants comes in Conic and Cylindrical formats. In the case of E.H. odonthological implants the torque is applied over the assembler and in the case of I.H. and Medullar implants directly over the internal hexagon. In E.H. Biodirect implants the torque application is performed directly on the implant fitting, and CM Biomorse implants the torque is applied directly on the implant, dispensing the use of assemblers.

List of accessories that should integrate the product:

Coverlid - It avoids waste deposit and even gum invagination in the implant’s internal thread. Models: MP, SP, RP, WP, T.D RP/WP, T.D 4.0/5.0, CM Biomorse.

Bushing - Implant fixation into the packaging (plastic tube) and support, it avoids damaging the product.

PRODUCT COMPOSITIONBionnovation implants are made of grade 4 titanium as per Norm ASTM F67.

INDICATION AND PURPOSE OF USE1. External Hexagon Odonthological Implants - E.H.The implants with an external hexagon provide a large quantity of components to solve esthetic and mechanical limitations, in addition to providing greater predictability and facilitating the surgeon’s work. The wrenches used to install them (they do not come with the product and are sold separately) can be easily adapted and provide torque on the assemblers. Maximum recommended torque: 55Ncm

2. Internal Hexagon Odonthological Implants – I.H.The implants with internal hexagon provide greater prosthetic stability, their cut chambers in the shape of a helix that accompany the entire body of the implant from the apex up to the micro threads favor blood clot drainage in addition to assisting the wettability of the implant’s surface during installation. The IH implants do not require an assembler, since the torque is applied directly on the implant’s internal hexagon. The torque applied during the implant installation procedure is transferred to the implant’s body, thus ensuring there isn’t any alteration in the connection between the implant and the prosthetic component, which may lead to complications during the prosthetic phase. Maximum recommended torque: 55Ncm

Accessories integrating and exclusive of the Classic and Conic ImplantsBushingCoverlidAssemblerAssembler Bolt

Accessories integrating and exclusive of the Classic and Conic Implants without assembler:BushingCoverlid

3. Biodirect ImplantsThe odonthological E.H. Biodirect implants are devices that dispense the use of assemblers, whose main advantages are a decrease in surgical times and in the probability of contamination. In addition to that, they have an external hexagon that allows for universal prosthetic adaptation, and internal geometry for installation (direct torque). The direct torque is applied internally on the implant, in whose cervical third there is an adaptation for the direct torque wrench (for torque wrench or counter-angle). Maximum recommended torque: 55NcmThe direct torque wrenches for counter-angle or torque wrench (they do not come with the product and are sold separately), are used for direct torque application in the implant’s internal part, without any contact with the external part of the external hexagon. These wrenches are coupled into the implant’s upper internal part, whose fitting must be perfect between both

of them. In addition to that, they allow transporting the same from the packaging to the surgical bed for installation. The wrenches must go through a decontamination and sterilization process before their use, under the medical professional’s responsibility.The E.H. Biodirect implants also come in the Expanded Platform (EP) models. In these models, the diameter of the platform is greater than the implant’s external diameter, which corresponds to the Expanded Platform. Among its advantages is the possibility of using the model’s prosthetic components related to the size of the platform (components for larger prosthetic spaces); installation of implants in an area with smaller osseous space, due to the presence of anatomical repairs and/or divergent tooth roots from the adjacent teeth, and greater prosthetic space, which favors both esthetics and bone tissue preservation.The XP E.H. Biodirect implants come with cut chambers at 120°, micro threads with a round valley profile, double thread, direct torque fitting for installation, 2.7-mm hexagon, active conic apex to facilitate installation and reduced collar height. As regards the EZ E.H. Biodirect implants, they have cut chambers at 120°, direct torque fitting for installation, 2.7-mm hexagon, micro threads with round profile, double threads with variable levels, spirals with a high cutting power, and conicity in the internal part of the thread (conic core).

Accessories integrating and exclusive of the Biodirect ImplantsBushingCoverlid

List of exclusive optional accessories for the Biodirect implant’s installation (sold separately, they do not come with the product)

Direct Torque Wrenches

Wrenches for direct torque wrench – used to install and apply torque to the implant.

Biodirect counter-angle wrenches – used to install and apply torque to the implant with a surgical engine (counter-angle).

Assembly of the Biodirect Implant and of the Direct Torque Wrench (sold separately, it does not come with the product).

Assembly - Direct torque wrench for counter-angle adapted to the Biodirect implant. Highlight of the cervical region: the wrench does not have external contact with the external hexagon.

The Biodirect implant must be installed with the counter-angle inserted only up to 2/3 of the body upon the perforation.

4. CM Biomorse Odonthological ImplantsThe CM Biomorse odonthological implants have an accurate internal conic format, which during installation of the abutment close into the implant promotes a close adaptation between the overlaid surfaces, acquiring a mechanical resistance similar to a single piece.It’s considered the internal retention system of the prosthetic element on the implant, employing the mechanical friction between the prosthetic component’s contact surface and the implant’s internal wall.

CurtaLonga

CurtaLonga

 

 

The CM Biomorse implants have been developed to improve the biomechanical properties of the prosthetic implant/pillar sets, and to reduce the incidence of the mechanical problems found in the internal and external hexagon systems. The connections provide a better adaptation between the prosthetic component and the implant, eliminating the micro-gap between both of them, reducing the peri-implant bone reabsorption levels, and providing a better mechanical stability for the pillar, thus minimizing the occurrence of micro-moves, while the micro-moves cause a reduction in the incidence of slackening and bolt fractures. The CM Biomorse implants provide a better anti-rotational fixation with indexer and greater resistance through the implant/pillar set fixed with a bolt, since the close link between both of them practically provides a mechanical response similar to a single body one, and with a low incidence of mechanical complications. It has a greater capacity of supporting horizontal loads, since it provides greater overlapping of the surfaces between the implant and the abutment, and also provides stability to the bone and gum tissues (discrete reabsorption).The implant’s internal geometry is comprised of a hexagon whose function is to convey the insertion torque to the implant. This internal torque system avoids the use of an assembler, eliminating the need of making transversal grooves on the implant’s platform, thus decreasing bacterial proliferation and facilitating the prosthesis’ cleaning.The XP CM Biomorse implants come with cut chambers at 120°, micro threads with round valley profile, double thread (faster installation), internal hexagon fitting for installation and anti-rotational fitting for the prosthesis, active conic apex to facilitate installation and lack of smooth collar. As regards the EZ CM Biomorse implants, they come with cut chambers in the shape of a helix, micro threads with round profile, double threads with variable levels, spirals with high cutting power, and conicity in the internal part of the thread (conic core), and lack of smooth collar.

Accessories integrating and exclusive of the CM Biomorse ImplantsBushingCoverlid

List of exclusive optional accessories for the CM Biomorse implant’s installation (sold separately, they do not come with the product and are registered separately).

Wrenches for Implant with Morse Cone type connection

Wrenches for CM Biomorse torque wrench – used to install and apply torque to the implant.

CM Biomorse counter-angle wrenches– used to install and apply torque to the implant with surgical engine (counter-angle).

Assembly of the CM Biomorse Implant with Morse Cone wrench (sold separately, it does not come with the product and is registered separately).

O5. Bionnovation Medullar ImplantThe Bionnovation Medullar Implants have an Internal Hexagon system with Conic and Cylindrical designs, with pyramidal thread profile, for faster installation and fewer traumas. These implants are devices that dispense the use of assemblers, and the torque is applied directly on the internal hexagon, and the implants’ transportation and installation are undertaken by the same wrench models used in the internal hexagon – I.H. odonthological implants. Maximum recommended torque: 55Ncm. They do not have an apex in their cut chambers; however, they’re indicated for bone densities of grade III and IV according to the bone classification of Lekhom and Zarb (1985).According to Lekholm and Zarb (1985), below you’ll find the bone quality classification in the maxilla and mandible: Grade I (Compact and homogeneous bone); Grade II (Compact bone surrounding the dense spongy bone); Grade III (Slim cortical bone surrounding a dense and spongy bone); and Grade IV

CurtaLonga

Curta Longa

(Fine cortical bone surrounding a little dense and spongy bone).los hueso esponjosos denso); Grado III (Cortical delgada circundando el hueso esponjoso denso) y Grado IV (Cortical fina circundando el hueso esponjoso poco denso).

The medullar implants’ advantage is that they decrease surgical times and provide high mechanical resistance. However, due lack of chambers they can only be used in the upper maxilla, but not in the mandible.

PRECAUTIONS, RESTRICTIONS AND WARNINGS1. STERILE- The product is sterile as long as package integrity, validity term and storage conditions are observed.2. USE BY PROFESSIONALS ONLY – The use of Bionnovation Classic Odonthological Implants is under the dentist’s responsibility and might depend on his previous qualification. Only dentists and professionals with knowledge on implantodontics techniques should use the same.3. The product cannot be reused, re-sterilized or reprocessed. If resterilized there may be oxidation on the graft’s surface, leading to fibrointegration instead of osseointegration.. Bionnovation does not recommend its reutilization, resterilization or reprocessing, discard it according to the applicable legislation for hospital waste, do not discard contaminated products in the general waste.4. The use of the product under inadequate surgical techniques and biosafety conditions may harm the patient leading to unsatisfactory results.5. Always sterilize the instruments before using them.6. Careful clinical and radiographic evaluations are necessary for a correct treatment planning, as well as to verify the anatomical structures that must be observed before perforation. An adequate safety margin adjacent to other teeth and vital structures must be preserved.7. In all surgeries involving odonthological implants please observe the appropriate asepsis and antisepsis techniques.8. - Abuse of alcohol, tobacco, drugs and corticosteroids or inappropriate oral hygiene may significantly compromise the success of treatment.9. - Patients should be informed in advance on all potential adverse effects such as dehiscence, inflammation, infection, bone loss, hemorrhage, allergic reaction, fracture or implant loss.An incorrect surgical technique may lead to discomfort, such as a painful sensation, hypoesthesia and edema.10. It’s supplied in the sterile state and after it has been opened it must be used under aseptic conditions. You should always work with sterile fields, appropriate instruments for the procedure and in good state of conservation in order to eliminate sources of infection.11. The implants must only be used for the purpose it has been designed.12. In the case of complications deemed impossible to be controlled, tissue inflammations or evidence of infection, we recommend you to immediately remove the implant.13. The implants are supplied in a sterile double packaging (Gamma Radiation 25 kGy). Provided the packaging’s integrity has not been compromised in any way whatsoever, it will keep the product sterile for up to 4 years to be counted as of the sterilization date.14. The surgeon shall evaluate its indication to patients diagnosed with diseases or that use a medication that might change the reparation metabolism15. - In the event of adverse events in patients, the professional in charge should contact Bionnovation Consumer Services (SCA) immediately at 0800 770 3824 or e-mail sac@bionnovation.com.br. Bionnovation Produtos Biomédicos is responsible for notifying ANVISA (Brazilian National Health Surveillance Agency) on the pertinent occurrences according to the techno-surveillance internal procedure.16. The Bionnovation Classic Odonthological Implants have been developed in order to avoid that its use might compromise patients’ clinical state and safety.17. There may not be osseointegration or posterior loss of the implant in cases where there isn’t proper bone quality or quantity.18. The Ø 2.9-mm implants are indicated for lower incisors and unitary prostheses, and their use in non-indicated areas may lead to implant fractures. It will be under the professional physician/dentist’s responsibility.

Bone type I

Bone type II

Bone type III

Bone type IV

E.H. and I.H. Implants • • • •E.H. Biodirect Implants • • • •CM Biomorse Implants • • • •Medullar Implants • •

19. The CM Biomorse implant’s installation must always be performed in parallel, without angles and installed 2 mm below the crest.20. The bone area that will receive the implant must be exposed and prepared (perforated) with adequate drills to receive the selected implant.

The milling sequence indicated for each implant diameter is described in the table:

Indicated milling sequence according to the external diameter of the implants’ bolt OBS: the milling cutters must be replaced on a regular basis in order to keep their cutting efficiency. They do not come with the product, and are sold separately.

- In the case of impact and the same bears large intensity scratches, crevices or creases, which might hinder the product’s proper functioning, it must be discarded and a new one must be acquired. Impacts may cause damage to the platform and to its dimensional characteristics.Note: We recommend that the identification adhesive labels that come with the product be annexed to the documentation to be delivered to the patient, to the clinical history, and to the collection documentation. CONTRAINDICATIONS- Implants should not be placed in an existing active infection or in any other degenerative disease that might affect the implants’ placement.- They should not be used in patients that are not able, under the clinical point of view, to be submitted to an odonthological intervention. Such as, for example, in patients suffering blood disorders, such as Diabetes Melitus and uncompensated periodontal disease.- Do not use in pediatric patients.- It’s contraindicated for procedures different from those recommended in item “Use Indication”

STERILITYImplants are provided STERILE (Gamma radiation 25 KGy). They are sterile provided package integrity is kept.

PRE AND POST-SURGICAL CARESUpon the pre-surgical evaluation, the correct indication of the materials and the employment of compatible techniques and procedures, as well as the follow-up and post-surgical controls, are indispensable to achieve the desired results.Pre-Surgical CaresAll the patients who will be submitted to a surgical procedure must be carefully examined and evaluated with the purpose of determining their radiographic and physical, as well as the bone or adjacent soft tissue deficit that might influence the final result of the intervention. Also, they require previous evaluation in order to minimize situations that might compromise the treatment’s success or even the patient’s safety. Post-Surgical CaresPlease, observe the post-surgical cares for surgical procedures. Analgesics, antibiotics and rest during the first 24-48 hours might be prescribed, varying as a function of the procedure and of the patient’s activity, and of the responsible professional’s technical conduct.

Milling Sequence for Bionnovation Classic Odonthological Implants

Ø 2,90 mm Ø 3,30 mm Ø 3,75 / Ø 4,00 mm Ø 5,00 mm

Spear Spear Spear SpearHelical Ø 2.20

mmHelical Ø 2.20

mmHelical Ø 2.20

mmHelical Ø 2.20

mmPilot Ø 2.45

mmPilot Ø 2.80

mmPilot Ø 3.20

mmPilot Ø 3.20

mmHelical Ø 2.45

mmHelical Ø 2.80

mmHelical Ø 3.20

mmHelical Ø 3.20

mmThread Ø 2.80

mmThread Ø 3.20

mm Reamer Pilot Ø 4.20 mm

Thread Ø 3.60 mm

Helical Ø 4.20 mm

Reamer Thread Ø 4.80

mm

SPECIAL CONDITIONS FOR THE PRODUCT’S STORAGE, TRANSPORTATION, CONSERVATION AND/OR HANDLING.Storage and transportationPlease, store and transport it away from direct sunlight and sources of heat. Keep the packaging sealed until the time of is use. Please, verify the integrity of the same before it is used. Do not use it if the sterile package has been opened, or if it’s damaged, or if the sterilization validity date has expired in order to avoid possible contamination. Discard any mischaracterized product according to the applicable legislation for hospital waste, or return the damaged packages to the factory, including the device.Conservation and handlingAny alteration in the implants’ characteristic, discard it in a mischaracterized form according to the applicable legislation for hospital waste, or return the damaged packages to the factory, including the device.

HOW SUPPLIEDImplants are fixed to the protection and support bushing, packed in a plastic tube with silicone cap, packed in a blister sealed with Tyveck® and inserted into the final package, which is a high grammage cardboard box sealed at high temperature. Implants are supplied in different diameters, heights and platforms in order to meet different clinical needs.

INSTRUCTIONS OF USE- The planning must also take into consideration the most adequate prosthetic options for balanced chewing forces, occlusal adjustment, esthetics and other factors related to the good performance of the prosthesis. The exchange of information between the surgeon, the prosthetist and the laboratory technician is paramount for the treatment’s success.- After the implant’s installation, the surgeon must evaluate the initial stability in order to determine if the implant may receive or not an immediate function.- Surgeries using drills must be undertaken by dedicating strict care to refrigeration, which must be performed continually with physiological saline solution, gradual increase of the drills’ diameter, and at low speeds. Excessive heating may cause permanent injury in the host tissue and consequently the implant’s loss. - External Hexagon (E.H.) and Internal Hexagon (I.H.) are public domain.

SEQUENCE OF INSTALLATION OF THE EXTERNAL HEXAGON (E.H.) BIODIRECT IMPLANT

2. Perforation with the 2.2 drill1. Initial perforation undertaken with spear drill

5. Perforation with a Counter Sink drill with the purpose of preparing the cortical bone so that the implant is adequately settled and to minimize the risk of excessive torque during installation.

6. TD Wrench for Counter-angle4. Perforation with a 3.2 conic drill. If necessary also use a 3.6 drill to provide better adaptation of the implant into the bone perforation.

7. Correct adaptation of the TD Wrench into the Counter-angle.

9. Handle the primary packaging (containing the implant) through the body of the tube. The cover bolt is protected by the seal found on the tube lid.

8. Sealed and sterile packaging. The identification label ensures the product’s traceability. Opening this packaging will expose the primary packaging, composed of a tube with implant and cover lid.

10. Capture of the implant through a TD Wrench. This wrench enables capturing the implant inside the packaging, its transportation to the surgical bed and the implant’s installation.

12. Transportation to the surgical bed. We advise you to transport the implant with its apex turned upwards.

11. Pay attention to the correct capture of the implant and full adaptation of the hexagon into the TD Wrench’s retention ring

13. The Biodirect implant must be installed with the counter-angle inserted only up to 2/3 of the body upon the perforation. The use of a counter-angle enable

15. TD Wrench for Torque Wrench.14. Finalization of the implant’s installation with a Counter-angle

16. TD Wrench’s adaptation into the surgical Torque Wrench.

18. INCORRECT adaptation of the TD Wrench, increasing the possibility of damage to the implant’s hexagon when the torque is applied.

17.Adapt the TD Wrench into the partially installed implant.

3. Perforation with 3,2pilot drill

19. ACORRECT adaptation of the TD Wrench into the implant’s hexagon. The TD wrench coupled to the implant enables the application of the final torque. The adaptation inside the implant also characterizes the internal application of the torque.

21. Finalization of the Biodirect Implant’s installation with surgical torque wrench until the implant’s locking.

20. Due to the project and design of the TD implant’s hexagon, the torque applied for installation should not exceed 80Ncm, thus avoiding permanent damage to the implant’s hexagon and enabling the posterior making of the prosthesis.

24. Removal of the protection seal and exposition of the Cover Bolt

23.Tube lid and Cover Bolt’s protection seal.

22. Biodirect Implant installed in a bone outfit

25. Capture of the coverlid with installation wrench for counter-angle or torque wrench. Observation for the utilization of the same wrench and adaptation into the lid, enabling the transportation and installation of the same on the implant.

26. Adapted set 27. Manual installation of the coverlid. Highlight to the wrench’s versatility, indicated for use with a manual torque wrench and manual wrench, in addition to the implant’s final installation and lid installation.

28. Finalized implant

01 04

06 07

02 05

07 08

03 05

07 08

09 09

10

0909

11

0909

SEQUENCE OF INSTALLATION OF THE CM BIOMORSE IMPLANTS

The chart below illustrates the recommended drilling and installation sequence for the Biomorse Implant systems. Clinical judgement with respect to each individual patient must supersede any recommendation made.

The drilling sequence for soft or dense bone can be selected at the time of surgery by simply choosing the final drill (Conical) in the appropriate diameter.

1. Initial perforation undertaken with Lance drill (05022);2. Prepare the surgical site with the twist drill Ø 2.2 mm (05002) until the height mark of the previous implant selected- (800 RPM);3. Use the Conical drill (specifically designed) to the increase of the surgical site from Ø 2.2 mm to Ø 2,8 mm (05018);4. Use the Conical drill (specifically designed) to the increase of the surgical site from Ø 2.8 mm to Ø 3,2 mm (05019);5. Sealed and sterile packaging. The identification label ensures the product’s traceability. Opening this packaging will expose the primary packaging, composed of a tube with implant and cover screw;6. Remove the TYVEK® label to expose the implant;7. Handle the primary packaging (containing the implant) through the body of the tube. With the Drive Lock C.M. for hand piece (Cod 13138 or 13139) pressure onto the implant until reaching the perfect fit;8. Take the set to the previously prepared surgical site and place the implant (20 RPM);9. If required, complete the installation with the Surgical Torque Wrench (13049) attached to Drive Lock C.M. for Ratched (13135 or 13136). Recommended insertion torque: 45 Ncm. Higher torques may cause irreversible damages to the implants as well as surgical complications.;10. After placing the implant, use the same Drive Lock C.M. ( they are fitted with 0.9 mm hexagonal ends) to place the screw (Cover Screw);11. Implant Installed.

CARE WHEN DISCARDING THE PRODUCTThe disposal of the product must comply with the environmental and bio safety laws in force. Do not discard contaminated products in the general waste.