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SEMPLICITY AND PREDICTABLE RESULTS IN IMPLANT PROSTHETICS

®

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WINSIX Implant System registered in 58 countries worldwide

AlbaniaAustriaAzerbaijanBelgiumBelarusBosnia and HerzegovinaBrazilBulgariaCanadaChinaCyprusColombiaSouth KoreaCroatiaDenmark

EgiptUnited Arab EmiratesEstoniaFinlandFranceGermanyJapanGreeceGuatemalaIndiaIranIrlandIslandIsraelItaly

RomaniaRussia (Federation)SerbiaSlovakiaSloveniaSpainSwedenSwissTunisiaTurkeyU.S.A.UkraineHungary

LatviaLebanonLihtuaniaLuxembourgMacedoniaMaltaMoldovaMontenegroNorwayOmanNederlandPolandPortugalUnited KingdomCzech Republic

3CHIRURGIA GUIDATA WINSIX

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CONTINUING GROWTH SINCE 1995

ITALIAN INTERNAL PRODUCTION ENTIRELY CONTROLLED

The deep knowledge of the sector and the sensitivity towards market social-health dynamics foster new projects, developed by ab efficient Research & Development department, in collaboration with the most prestigious Italian Universities and international Research Centres.

BIOSAFIN is specialized in the designing, production and marketing dental implants, customized orthodontic devices, instruments and units for oral surgery.We are an entirely Italian company, whose know-how is based on Scientific and Technological Research since 1995, and in which the company continually invests part of its profits.

In addition to WINSIX® Implant System – in clinical use since 1995 and today registered not only in Italy but also in 58 countries all over the world – BIOSAFIN proposes an Instrument line and specific Material for ORAL SURGERY, remaining true to company principles of ergonomics, efficiency and technological development.

BIOSAFIN DOUBLE PATH OF QUALITY

BIOSAFIN pursues Company and Product quality criteria.Thanks to the solid scientific background and the Research, we have obtained the following certifications:

UNI EN ISO 9001: 2015 relevant to 360-degree company work processes UNI CEI EN ISO 13485: 2016 relevant to medical device quality.

The maintenance of qualitative parameters requested by the Certifications is periodically examined and revalued according to the regulations.

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REHABILITATION TIMES IN IMPLANT PROSHTETICS

WITH GUIDED SURGERY

WITH IMMEDIATE LOAD

VALIDATES PROTOCOLS

IMPLANT PLACEMENT

PROSTHESIS DELIVERY

CHECKUP + DIAGNOSIS + TREATMENT PLAN

CHECKUP + DIAGNOSIS + TREATMENT PLAN

IMPLANT PLACEMENT + IMPRESSIONS

CONSTRUCTION OF THE PROVISIONAL PROSTHESIS WITHIN 72 HOURS.

PROSTHESIS DELIVERY

OPERPULECTOMY + IMPRESSION AFTER 3/6 MONTHS

CHECKUP + DIAGNOSIS + TREATMENT PLAN

IMPLANT PLACEMENTTEMPORARY PROSTHESIS CONSTRUCTION AND DELIVERY

PERMANENT PROSTHESIS DELIVERY IN 4/6 MONTHS

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WINSIX GUIDED SURGERY

DEFERRED CONVENTIONAL

SEMPLICITY AND PREDICTABLE RESULTS IN IMPLANT PROSHTETICS

3D imaging, applied to implantology, enables to plan the most suitable surgery, the number and the position of the implants, and the right prosthetic solution.The protocol processes patient data, which are acquired with digital techniques, formulating adequate therapeutic solutions thanks to medical imaging.

Planning the surgery with 3D WINGUIDE Software, it is possible to take in exam several rehabilitation solutions, simulate prosthetic solutions and eliminate precisely individual functional and aesthetic parameters. In this way, rehabilitation times are optimised, surgical risks are minimised and the results respond to expectations.

Guided Implant Surgery technique allows, once anatomic and patient’s health conditions are verified,implants placement through a prepackaged surgical guide by using Flapless surgery without sculpting mucoperiosteal flaps.

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FLAPLESS SURGERY

A STEP FORWARD IN YOUR PROFESSION

YOU AND THE PATIENT, WHICH BENEFITS?Thanks to digitalization, the dentist can show the surgery video preview and has the possibility to discuss therapeutic choices with the patient. Sharing these phases with the patient, favours the communication and enhance the therapeutic value of the surgery, as well as respect and trust in the dentist.

Thanks to the possibility of planning with precision the implant placement, Guided Surgery is optimal in immediate load cases, with the opportunity to build the temporary prosthesis before implant placement.

After evaluating bone quality and quantity, and planning the surgery virtually, Guided Surgery allows to place implants with Flapless technique, without sculpting mucoperiosteal flaps, significantly reducing patient discomfort, who will have minimum surgery and postoperative times.

The results are immediately perceived by the Patient, who recovers functionality and aesthetic.

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PATIENT

DIAGNOSTIC PROGETTAZIONE

PATIENT CBCT OR TC EXAMINATION PERFORMANCE BOTH ARCHES

EXAM OF THE PRELIMINARY VIRTUAL

PATIENT CREATION

Phase Phase Phase Phase

IMPRESSION TAKING OF

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Anamnesis-Medical examination-Interview-Treatment plan presentation

-TROUGH INTRAORAL SCANNER IN THE STL FORMAT, at the Studio. Suitable for partially edentulous cases-WITH TRADITIONAL IMPRESSION. Suitable for fully edentulous cases. Model scanning in laboratory, with Fiducial Marker in position.

MODALITIES OF THE TRANSMISSIONS OF THE DATA:

VIRTUAL PATIENT creation can be made by the dentist in his own studio with the specific program, after the dedicated training.

1.VIA INTERNET(winsix.wetransfer.com)these files:a. radiographic scan in ICOM formatb. STL scan by intraoral scanner (partial edentulism)OR:a. STL scan plaster model + Radiographic Template + Fiducial Markerb. STL scan plaster model + Radiographic Templatec. STL scan plaster model made with a laboratory scanner (cases in which Fiducial Markers are used)2. BY COURIER a. Plaster Modelb. Radiographic templatec. Fiducial Markerd. TC on CD

GUIDE YOUR IMPLANT PROSTHETIC REHABILITATION IN A PLANNED

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CREAZIONE DEL VIRTUAL PATIENT

MODALITÀ DITRASMISSIONE DEI DATI:

1. INVIO TRAMITE INTERNET

(winsix.wetransfer.com) dei seguenti file: a. Scansione radiografica in formato DICOM b. Scansione STL da Scanner intraorale (edentulia parziale)OPPURE: a. Scansione STL Modello in gesso + Dima Radiografica + Fiducial Marker. b. Scansione STL Modello in gesso + Dima Radiografica c. Scansione STL Modello in gesso

realizzate con scanner da laboratorio (casi in cui si usino i Fiducial Marker)

2. INVIO TRAMITE CORRIERE DI: a. Modello in gesso b. Dima radiografica c. Fiducial Marker d. TC su CD

La creazione del VIRTUAL PATIENT può essere effettuata dal clinico nel proprio Studio con il programma specifico, dopo apposito training.

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PLANNING SURGERY

Phase Phase Phase Phase

IMPLANT PLANNING

DENTISTAPPROVAL

CONSTRUCTION AND DISPATCH OF

THE SURGICAL TEMPLATE

SURGERY

OPERATING SEQUENCES IN RELATION TO THE EDENTULISM TYPE

WINSIX Computer-assisted Surgery Centre provides file matching and preparatory planning of the surgery if requested.

The Dentist verifies the planning and shares it with the Patient.

Surgical template print is subsequently approved filling the suitable form.

Once the surgical template and the model with the planned positions of the implants are made, they are sent to the Dentist.

Verification of necessary components:

- Surgical Kit- Surgical Template- Surgical Index- Planned Implants- Prosthetic Components- Possible Temporary

. Fiducial Marker construction

. Fiducial Marker placement on the model and on the oral cavity. model optical scanning with Repere. virtual diagnostic wax-up. CBCT examination with placed Repere

FULLY EDENTULOUS CASES. traditional impression for edentulous saddle. diagnostic temporary prosthesis construction . radiographic template construction. Fiducial Marker fastening on the replication. TC examination with inserted prosthesis . model optical scanning. model optical scanning and prosthesis . model optical scanning, prosthesis and Fiducial Marker

PARTIALLY EDENTULOUS CASESA) Classic technique. precise analogic impressions of the partially edentulous arch . model casting

B) Digital technique. digital impressions. Model 3D prints

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YOU AND THE LABORATORY, WHICH BENEFITS?

8 WINSIX GUIDED SURGERY

YOUR FAST AND PRECISE PROSTHESISThe integration of CAD digital impressions (Computer Aided Design) – or of traditional impressions subsequently scanned – with CAM system (Computer Aided Manufacturing) consists in a better precision of the prosthetic device and a faster workflow, because the plan can be sent via mail directly to the trustworthy dental technician who will provide to sent you the finished device.

In this sense, the relationship with the Laboratory becomes easier, overcoming space and time limits.

FUNCTIONAL AND DEDICATED INSTRUMENTSWINSIX® kit for Guided Surgery offers a unique and ergonomic box with all the necessary instruments.The software is simple and intuitive to use, and it guides the dentist step by step to build the ideal project. 3D Model construction is immediate and instantly ready for exporting it in SLT format and to be sent to the Laboratory.

CUSTOM SERVICE BIOSAFIN devotes specific resources to technical assistance during Start Up phases of the Dentist, that are software installation and training.

Moreover, those who wish to approach this technique for the first time without engagement, ONE SHOT package + company Specialist direct Assistance.

WINGUIDE is an open and simple software responsible for importing STL files sent by the Laboratory or intraoral scanner and submit them to the Patient with his anatomic structures, also providing opposite bite scan and virtual wax-up.WINGUIDE interacts with every 3D model of the Patient (TC/CBCT/RM images), which is imported and transformed into DICOM file.

DICOM operational interface is simple to use, intuitive in its sequences and guides the dentist to the immediate 3D reconstruction of the anatomic regions concerned, through automatic report.Each step is supported by tutorial video that clear up any doubt.These elements are sufficient to move from planning the placement of prosthetically-guided implants to realisation.After planning, the case is exported in STL format to realize models, surgical guide and prepare prepackaged prosthesis.

WINGUIDE is a CE certified medical device, IIA class.

WINGUIDEAN OPEN, PRECISE AND SIMPLE SOFTWARE

9CHIRURGIA GUIDATA WINSIX

CASE REPORT

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MICHELE MANACORDARaffaele Vinci, Francesco Bova, Enrico Felice Gherlone

Vita-Salute San Raffaele University, Milan - The Graduate Degree Course in Dentistry and Dental ProstheticsPresident: professor E.F. GherloneIRCCS San Raffaele Hospital, Milan – Department of Dentistry - San Raffaele Dental ClinicDirector: professor E.F. Gherlone

Fig.IAfter the construction of two post-extraction total diagnostic prosthesis, wait for tissue healing and value new occlusal plane congruity, aesthetic and functional parameters of the prosthetic plan.

Fig. 23D reconstruction of the edentulous facial bone draws attention to the extraoral repere which was applied on the prosthesis during the examination.Surgical anatomy viewed through software elaboration allows to accurately realize 3D virtual implant plan.

Fig. 3Model and diagnostic prosthesis optical scanning, made with radio-opaque marker, are entered in the diagnosis software, facilitating the planning, implant choice and prosthetic connections.

Fig. 4Implant planning viewed in pseudo-panoramic shows the surgical choice of a mandibular Just On type rehabilitation.The two “tilted” distal implants and it is possible to see a preview of their emergence in correspondence of second bicuspid on the planning software which integrates the anatomy with the prosthetic plan.

Fig. 5The temporary prosthesis for immediate load, which is realized on stereolithographic model, is made through milling in the solid in CAD/CAM and then finished and characterized.

Fig. 6Surgical template placement through silicone surgical index.Before inserting planned fixation pin, the Patient hold the template in the right position with the help of the vallum, facilitating his placement and stability on the resilient mucosa.

Fig. 7 - 10Implant guided placement is carried out through dedicated mounter. At the endstop, mounter and guide cylinder hexagonal profiles have to coincide. In this way, abutment installation on the external hexagon of implants corresponds to what planning software foresaw. At the end of the surgery, the placement of passivated and screwed prosthetic elements.

Fig. 11Control CBCT after six months from load and after the realization of the definitive prosthetic device, in which two elements with distal extension have been added.

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CLOSED KIT

WINSIX GUIDED SURGERY KIT

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ONE SHOT + on-line consuelingOptical Scanning + STL exportSurgical Template 1 implantwith 3D modelSurgical Template 2/3 implants with

Fiducial MarkerRental Instrument Kit

Surgical Template for post-extraction implants with 3D model

Surgical Template 7 Implants with 3D model

Surgical Template 4/6 implants with 3D model

3D Model

Internal Hexagonal connection Driver External Hexagonal connection DriverConical connection DriverDriver Torque Wrench

Guided Surgery Drill Ø:3.8/4.2 mm - L:15 mmGuided Surgery Drill Ø:3.8/4.2 mm - L:13 mmGuided Surgery Drill Ø:3.8/4.2 mm - L:11mm

Guided Cortical Drill for Implants Ø 3.3 mmGuided Cortical Drill for Implants Ø 3.8 mmGuided Cortical Drill for Implants Ø 4.5 mm

Guided Surgery Drill Ø:3.8/4.2 mm - L:7mm Guided Surgery Drill Ø:3.8/4.2 mm - L:9mm

Guided Surgery Drill Ø:3.4/3.8 mm - L:13 mmGuided Surgery Drill Ø:3.4/3.8 mm - L:15mm

Guided Surgery Drill Ø:3.0/3.4 mm - L:11 mm Guided Surgery Drill Ø:3.0/3.4 mm - L:13 mm Guided Surgery Drill Ø:3.0/3.4 mm - L:15mm Guided Surgery Drill Ø:3.4/3.8 mm - L:7mm Guided Surgery Drill Ø:3.4/3.8 mm - L:9mm Guided Surgery Drill Ø:3.4/3.8 mm - L:11mm

Guided Surgery Drill Ø:3.0/3.4 mm - L:7 mm Guided Surgery Drill Ø:3.0/3.4 mm - L:9 mm

Guided Surgery Drill Ø:2.6/3.0 mm - L:11mm Guided Surgery Drill Ø:2.6/3.0 mm - L:13mm Guided Surgery Drill Ø:2.6/3.0 mm - L:15 mm

Guided Surgery Drill Ø:2.2/2.6 mm - L:9 mmGuided Surgery Drill Ø:2.2/2.6 mm - L:11mmGuided Surgery Drill Ø:2.2/2.6 mm - L:13 mm

FIXING PIN DRILLFIXING PIN Surgical TemplateM ucotom eInitial drill for implant site preparation

Guided surgery drill Ø:2.2/2.6 mm - L: 7 mm

Guided Surgery Drill Ø:2.2/2.6 mm - L:15mm

Guided Surgery Drill Ø:2.6/3.0 mm - L:9mm Guided Surgery Drill Ø:2.6/3.0 mm - L:7 mm

Online software WINGUIDE introductive coursePlanning verification

Cod

. Ed.

3/IT

A/IV

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GLOBAL QUALITY:

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BIOSAFIN is an ISO 9001 company which certifies the entire work process, confirming its conformity with the optimal quality requirements in order to safeguard product User – Specialist and Patient.

BIOSAFIN is also a UNI CEI EN ISO 13485 company which certifies Medical Devices Quality.

WINSIX Certifications

BIOSAFIN srl info@biosafn.com biosafin.com

ITALY HEADQUARTERS:

20060 - Trezzano Rosa –industrial area (MI)Tel. +39 02 90968692fax +39 02 90968541ANCONA: Via Tiraboschi, 36/G60131 - Ancona (AN)Tel. +39 071 2071897fax +39 071 203261

Via Cagliari 32/44