Alpha Bio Implants User Protocol

1 Alpha Bio Implants User Protocol Edited by: Dr. Ophir Fromovich CEO of Alpha Bio Ltd., Petch-Tikva, Israel

2 TABLE OF CONTENTS I. Surgical Kit - p. 3 II. Basic Contents of the Surgical Kit - p. 3 1) DR - 6 Drills p. 3 2) DX - Driller Extension p. 3 3) PDG - Depth Gauges and Parallelograms p. 3 4) PG - Titanium Parallelogram Meter - p. 4 5) IT - 2.5mm Driver - p. 4 6) HT- 1.25mmd Driver - p. 4 7) RAT - Ratchet - p. 4 8) SDH - Bolt Driver - p. 4 9) IDG - p. 4 III. SPI, SFB, DFI and ATIOF, ATD Implants - p. 5 General - p. 5 1) SPI Implant Spiral Implants - p. 5 2) DFI Implant Dualfit Implants - p. 5 3) ATIOF, ATD Implant Alpha-Tec Implants - p. 6 4) SFB Implant Spiral Flare Bevel - p. 6 IV. ARRP/ARRB /ARR/ARRB Implants p. 7 2. Implant Mount - p. 8 3. Cover Screw - p. 8 4. Implant Packaging - p. 8 5. User Warning - p. 8

3 Alpha-Bio Implants - User Protocol I. Surgical Kit Alpha Bio's Surgical Kit packaging consists of a base box and a lid. The base box is pierced at its bottom; it enables sterilization with Autoclave devices. The lid is connected to the base box by two locking devices on its sides. Inside the base box a work tray can be found, where the tools are placed. This tray can be taken out and placed on the working area by using the two pins located on its sides. On the work tray are silicon stands designed for placement of the surgical tools. Under each silicon stand, one finds an article number indicating where each of the surgical tools has to be placed. On the upper surface of the work tray, at its right side, there are sixteen (16) empty stands for the placement of additional tools these are designed to accommodate each doctor's individual needs. On the upper surface of the work tray, at its left side, you can find a storage bowl, to be used by the doctor for his immediate needs. II. Basic Contents of the Surgical Kit 1) DR - 6 Drills (2mmd-white, 2.8mmd-red, 3.2ddm-blue, 3.65ddm-green, 4.3ddmblack.). The drills are made from titanium to prevent corrosion. It has a color coding mark at its base, which indicates the drill's diameter. It is designed for quick identification during the surgical procedure. The length of the driller's active part is up to 16mm indicated by slots: 8mml,10mml,11.5mml,13mml,16mml. 2) DX - Driller Extension (stainless steel) It can be connected by its hollow part to the driller's passive part by pushing the driller's passive part into its extension. The passive part of the driller's extension connects to a try-square (a "click" sound indicates the locking.) in a narrow space between adjacent teeth, 3) PDG - Depth Gauges and Parallelograms (titanium] - The gauges fit 2mmd drill holes. At its lower part can be found a step indicator - each step equals one millimeter. It is also intended for accurate measurement of RX distoration.

4 4) PG - Titanium Parallelogram Meter The long pin fits a 2mmd drill. On its horizontal level can be found a short pin. It has a rounded hole of 2.3mmd that fits a 2mmd drill. The use of the parallelogram meter, allows keeping a 7mm distance from the center of the implant's diameter to the next one, while keeping a distance of 3mm between the bodies. 3.75mmd between one implant to the other. 5) IT - 2.5mm Driver (stainless steel) The active part of the driver (with its hexagonal formed edge). It fits to the hexagonal of the implant's head, once the mount has been taken out (enables to continue screwing in a narrow space between adjacent teeth). 6) HT - 1.25mmd Driver (stainless steel) This driver is designed for the screwing and/or unscrewing all types of abutemets and healing screws. 7) RAT - Ratchet (stainless steel) Designed for implant insertion. The ratchet has a round head, with a hexagonal hole at its center. It fits the hexagonal form of the implant mounts. With one turn of the ratchet, the ratchet will turn the implant mounts and the implant itself. This way the dentist can reach the desired depth. Please Notice: The ratchet fits the drivers found in the surgical kit. 8) SDH - Bolt Driver( stainless steel) - Serves for implant placing [optional]. The Bolt Driver is made of a grip handle and an active part. At its active part edge, there is a hexagonal hollow formed head, which fits the implant's mounts. A single turn of the bolt key will turn the implant mount and the implant itself to the doctor s desired depth. Please notice: The Bolt driver fits also the drivers found in the surgical kit. 9) IDG -(stainless steel) The IDG is a depth measuring tool. The device tool is built of a grip handle, which at its both ends has probes. Each probe has at its round edge of 2.7mmd and 1.9mmd and lenght mark on 8mml, 10mml, 11.5mml, 13mml, 16mml. IDG is designed to measure depth undertaken during the implantation process or sinus membrane test during sinus lift.

5 III. SPI, SFB, DFI and ATIOF, ATD Implants General Alpha-Bio implants are made of titanium alloy with a hybrid surface design. The Alpha-Bio implants have a rough surface design S.L.A. on its body and on its upper part an acid etched surface. 1) SPI Implant Spiral Implants (single platform) Diameters: 3.75, 4.2, 5,6mmd. Length: 10,11.5,13,16 mml (exception - a 6mmd implant which can be extended to 13mm). Drill Sequence for Bone Type 1 SPI 3.75mm 2.8mm drill 3. SPI 4.2mm 2.8mm drill 3. 3.65mm drill SPI 5mm 2.8mm drill 3. 3.65mm drill 4.3mm drill SPI 6mm 2.8mm drill 3. 3.65mm drill 4.3mm drill - 5.5mm drill For bone types 3-4, you can skip the last drilling sequene. When bone is very soft, skip the last two drilling sequences. 2) DFI Implant Dualfit Implants (single platform) Diameters 3.3,3.75,4.2. 5mmd Length 8,11.5,13,16mml Drill Sequence for Bone Type 2-4 DFI 3.3mm 2.8mm drill DFI 3.75mm 2.8mm drill 3. DFI 4.2mm 2.8mm drill 3. 3.65mm drill DFI 5mm 2.8mm drill 3. 3.65mm drill 4.3mm drill For bone type2-3-4

6 3) ATIOF, ATD Implant Alpha-Tec Implants (single platform) Diameters 3.3,3.75,4.2,5.,6mmd. Lenght 8,10,11.5,13.16mml (exception: 5mm and 6mm implants which come in 6mm, 8,10.11.5, 13mml.) Drill Sequence for Bone Type 1 and 2 ATI 3.3mm 2.8mm drill ATI 3.75mm 2.8mm drill 3. ATI4.2mm 2.8mm drill 3. 3.65 drill ATI 5mm 2.8mm drill 3. 3.65mm drill 4.3 mm drill ATI 6mm 2.8mm drill 3. 3.65 drill 4.3mm drill 5.25mm drill (last) 4) SFB Implant Spiral Flare Bevel Diameter: 4.2,5, 6mmd Length: 10,11.5,13,16mml Drill Sequence for Bone Type 1 SFB 4.2mm 2.8mm drill 3. SFB 5mm 2.8mm drill 3. 3.65mm drill SFB 6mm 2.8mm drill 3. 3.65mm drill 4.3mm drill You can skip the last drill for bone 3. When the bone is very soft, you can remove the last two drills.

7 IV. ARRP/ARRB. /ARR/ARRB Implants ARRP Arrow Press Implants Diameter 3, 3.3, 3.6mmd Length 11.5 13, 15mml Drill Sequence for all Bone Types ARRP 3mm ARRP 3.3mm ARRP 3.3mm Please notice: The implant's diameter is measured by its upper thread (in the apical mode, the implant's diameter is smaller.) 1. ARRB Implants. The implants are made of one piece including the abutment. The ARRB comes with an abutment that its upper part is ball formed. These implants fit all bone types as temporary implants and on going implants. Their special feature is their adaptability to a condition where a load division is necessary. Namely, there small diameter enables introducing them during the implant process between permanent implants, to avoid increased load on permanent implants and for temporary bridge. Diameter - 2.4mm Length: 10mm, 13mm and 15mm. Drill Sequence for all Bone Types ARR 2.4mm ARRB 2.4mm ARRP 3.3mm Note: ARR/ARRB and ARRP implants are inserted into the bone with a special driver called AHT. The driver's active part is hollow (enables the introducing of the abutments at the implants heads), while its' upper part fits the connection to a ratchet. For a ARRB implant, the driver is called AHTB.

8 2. Implant Mount FID (Fast Implant Delivery) The mount is modular and fits all Alpha-Bio's implant types. The FID is a unique implant mount with a stronger capacity. It is used by a "clicking" system (The mount is attached by pressure without using a screw the guide is freed by simply pulling it.) The FID guide is an improved guide with new features: The implant s insertion process is simpler. In the absence of a connection screw, no need for a 1.25mm driver to disconnect the implant from its mount. The mount upper part has a hexagonal form from the inside; enables the mounting of a IT- 2.5mm extensions (of variable sizes). It prevents the contact of the ratchet with the lips and teeth. When you feel bone resistance while inserting the implant, take out the mount, use IT - 2.5mm extensions. Unscrew the implant 2 to 3 times counter clockwise. From this point continue screwing the implant in the ordinary way. 3. Cover Screw It is made of titanium, and is provided with the implant package. To screw it onto the implant's hexagonal part, you have to use a HT 1.25mmd driver. 4. Implant Packaging All Alpha Bio's implants come in a sterile blister packaging. On the external part of the blister packaging can be seen the implant together with the cover screw. In addition, a sticker displays all the implant's specifications: type, diameter, length, hexagonal features and the product's raw material specifications. A similar sticker is attached to the implant itself. On the implant s back are featured the user warning instructions and company information. Please Notice: The implant s packaging is designed for quick opening without creating any contact with the implant s body. The blister envelope is rounder at its edges, but one of its sides is larger - this enables the opening of the envelope when placing it on the work tray. 5. User Warning The use of Alpha Bio s implant, kit is the responsibility of the individual user and is subject to the binding laws and conditions in the user s country.