LOCATOR abutment and collar for VARIOmulti

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1 INFO LOCATOR abutment and collar for VARIOmulti Advantages at a glance A proven implant attachment system Corrects implant divergences Fits on every VARIOmulti abutment Easy assembly

2 ZEST LOCATOR abutment and collar for VARIOmulti The LOCATOR abutment and collar can be used with straight and angled (17 and 30 ) VARIOmulti abutments. The 3 mm wide collar is screwed directly onto the VARIOmulti abutment using the LOCATOR component. The new collar and LOCATOR attachment in combination with angled VARIOmulti abutments allows the clinician to compensate for greater implant divergences. The direction of insertion is then optimized for overdentures and denture fi t is better controlled, ultimately allowing for easier attachment and removal of the denture by the patient. The collar and LOCATOR combination also offers new temporary restoration possibilities on VARIOmulti abutments. 3 mm Limitations to use Use with VARIOmulti abutments PF 3.5 mm is contraindicated. Not appropriate where a totally rigid connection is required. Use Attach the VARIOmulti abutment on the implant with the appropriate fi nal torque. Affi x the LOCATOR insert for hand piece (Art. no or 8914) in the dental coupling of the short MONO insertion device. With the MONO insertion device and MONO torque ratchet, tighten the LOCATOR abutment and collar on the VARIOmulti abutment to a torque of 20 Ncm. LOCATOR abutment and collar for VARIOmulti 2 sets per pack LOCATOR insert, for hand piece and for short MONO insertion device, stainless steel Length 23.0 mm mm 8914 MONO insertion device, stainless steel/peek Length short * 15.4 mm * All latch-type instruments can be utilized with the MONO insertion device, short. MONO torque ratchet, titanium alloy Length mm Fo_02d /14 canarini communications

3 LOCATOR Implant attachment system SWISS PRECISION AND INNOVATION. SWISS PRECISION AND INNOVATION.

4 Notes EXPLANATION OF SYMBOLS Batch code Use by date Date of manufacture Sterilized using irradiation Sterilized using ethylene oxide Sterilized using steam or dry heat Temperature limitation Do not re-use Non-sterile Caution Article number Conformity symbol as specified by EU Directive MDD 93/42/EEC Consult instructions for use Do not resterilize Do not use if package is damaged Atmospheric pressure limitation RESPONSIBILITY/LIABILITY As part of an overall scheme, Thommen implants may be used only with the ori ginal components and instruments in accordance with the manufacturer s instructions. The use of unapproved components from other systems can cause malfunctioning of the implants and abutments and lead to implant failure. The use of the product is the responsibility of the user and, as such, beyond the control of Thommen Medical AG. We refuse to accept any re sponsibility or liability for any damage due to incorrect utilization of the product. Products labeled Do not re-use may not be refurbished and/or reused. The refurbishment and/or reuse of these products can affect their function (fi tting and/or cutting properties) as well as their safe use (risk of infection, disease transmission, fading of the laser or color marks, corrosion). Detailed information about the possible conse quences, which may result from negligence to follow this information, is avail able from your dealer. Caution: Federal law (USA) restricts this device to sale by or on the order of a dentist or physician. GUARANTEE OF STERILITY OF STERILE PRODUCTS Products of the Thommen Implant System supplied in sterile packaging must not be resterilized. If the sterile packaging is damaged during transport or storage, the product must not be used. Products that have been opened and have not been immediately used for the intended operation must not be used thereafter. After resterilization, the safety, function and effi cacy of the product cannot be guaranteed by the man ufacturer. STORAGE Please note the specifi cations on all labels and package leafl ets regarding transportation, storage and instructions for use. INSTRUCTIONS FOR USE The following information is not intended as comprehensive for the Thommen Implant System. New customers are advised to undergo training by a specialist experienced in the use of this system. VALIDITY This product catalogue replaces all previous editions. Manufacturer Keep away from sunlight PRODUCT DOCUMENTATION You can fi nd detailed information on the han dling of Thommen implants in our brochures. Ask our national representatives for product brochures and instructions for use. May only be sold to and prescribed by physicians (USA) AVAILABILITY NOTE Not all products shown in this brochure are available in all countries. For further information please contact our subsidiary or distributor in your country. COLOR CODE Each implant platform dia meter has a color code, which can be found on all implant packs, on the impression items and on most diameter-specifi c instruments. COPYRIGHT /REGISTERED SPI, INICELL, APLIQUIQ and Remotis are registered trademarks of Thommen Medical AG. Publication or reproduction is permitted only with the written consent of Thommen Medical AG. LOCATOR is a registered trademark of Zest Anchors Inc., CA, USA. Yellow = Green = platform 3.5 mm platform 4.0 mm COLORED WARNING STICKER Application was changed follow the instructions in the corresponding documentation. Blue = platform 4.5 mm New design the application has not been changed. Grey = platform 5.0 mm Violet = platform 6.0 mm 2 Thommen Medical

5 Contents LOCATOR Implant attachment system 4 Placement of the LOCATOR abutment 6 Determining the angulation 7 LOCATOR male replacement by the dentist 8 LOCATOR male replacement by the dental technician 12 How to change the LOCATOR male replacement 14 Reline and rebase 16 Product overview 18 Thommen Medical 3

6 LOCATOR Implant attachment system The LOCATOR implant attachment system is available for Thommen implants with platform 3.5 mm and major. Advantages at a glance Lowest vertical height Locating design Retention inside and out Rotational pivoting action Suitable for non-parallel implants 4 Thommen Medical

7 The total height of the LOCATOR attachment (abutment plus LOCATOR cap incl. male replacement) is only 3.5 mm on an Thommen implant making it ideal for cases with limited vertical space. The self-locating design allows a patient to easily seat their overdenture without the need for accurate alignment of the attachment components. The patented Dual Retention innovation provides the LOCATOR attachment with greater retention surface area than ever before available with other attachments. The LOCATOR attachment provides both internal and external retention to securely hold the overdenture in place. The design of the pivoting LOCATOR male allows a resilient connection for the prosthesis without any resulting loss of retention. Throughout its range of movement, the nylon male remains in contact with the LOCATOR abutment. The LOCATOR male replacements can be used to restore an implant with up to 10 degrees of divergence (20 degrees between implants). The LOCATOR extended range male replacements can accommodate a divergence between 10 and 20 degrees (40 degrees between implants). Indications The LOCATOR attachment system is designed for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. Contraindications The LOCATOR attachment system is not appropriate where a totally rigid connection is required. Use on a single implant with divergence of greater than 20 degrees is not recommended. Sterilization All components and instruments are supplied non-sterile. Abutments and metal instruments should be cleaned and autoclaved before use. This document contains the most current instructions for use. Thommen Medical 5

8 Placement of the LOCATOR abutment * 1. To select the proper LOCATOR abutment, determine the diameter of implant being used. Then measure the tissue thickness from the apical rim of the implant body to the crest of the gingiva at the highest side of the implant site. Select the corresponding LOCATOR abutment tissue cuff height that exactly equals the tissue measurement, or is the next closest higher size available. The exact tissue cuff height of LOCATOR abutment will position the proper 1.5 mm of working attachment above the surrounding gingival level (the working attachment should not be submerged below the tissue). 2. The MONO insertion device, short (art. no ), has an internal dental latch which fits with the LOCATOR insert, for handpiece and for short MONO insertion device (no or 8914). 3. Attach the LOCATOR insert to the MONO insertion device, short, and use it to hand tighten the LOCATOR abutment. Then torque the LOCATOR abutments using the MONO torque ratchet. The final torque for LOCATOR Abutments PF 3.5 mm is 20 Ncm; the final torque for PF mm is 30 Ncm. Note It is recommended that any LOCATOR implant abutment gets checked at future recall appointments to ensure that appropriate torque value is maintained. * * symbolic illustration 6 Thommen Medical

9 Determining the angulation 1. Determine the angulation of the LOCATOR abutment by attaching a LOCATOR parallel post (art. no. 8517) to it and measuring the angle with the LOCATOR angle measurement guide (art. no. 9530). * 2. Select the final LOCATOR male replacement retention liner based upon the determined angle measurement of each implant. If the divergence of an implant is less than 10 degrees, use one of the LOCATOR male replacements (clear = 5 lbs, pink = 3 lbs, and blue = 1.5 lbs). If the divergence of any implant is between 10 degrees and 20 degrees, then use one of the extended range male replacements (green 1 = 4 3 lbs, orange = 2 lbs. and red = 0.5 lbs) which can accommodate a divergence up to 20 degrees (40 degrees between implants). 1 The retention value is dependent upon the degree of angulation; at 10 degrees the retention would be 4.0 pounds and at 20 degrees the retention would be approximately 3.0 pounds. 3. Follow the steps in section, LOCATOR male replacement by the dentist, or the steps in section, LOCATOR male replacement by the laboratory. * symbolic illustration Thommen Medical 7

10 LOCATOR male replacement by the dentist Dentist 1. Insertion of the proper LOCATOR abutment at tissue level must be completed (see page 6 placement of the LOCATOR abutment ) before beginning the procedure for placement of the LOCATOR male. 2. Place a white block-out spacer (art. no and included within the package of art. no ) over the head of each LOCATOR abutment. The spacer is used to block out the area immediately surrounding the abutment. The space created will allow the full resilient function of the pivoting LOCATOR cap over the LOCATOR male. * Note If the white block-out spacer does not completely fill the space between the tissue and the LOCATOR cap, it is necessary to block out any remaining undercuts to prevent the added acrylic resin from locking the denture onto the abutment. This can be accomplished by stacking more block-out spacers. 3. Insert a LOCATOR cap with black processing male (part of the LOCATOR male processing package, art. no package or separate as a package with 20 pieces, art. no ) into each LOCATOR abutment, leaving the white block-out spacer beneath it. The black processing male will maintain the overdenture in the upper limit of its vertical range of movement during the processing procedure. * 4. Prepare a recess in the denture to accommodate the protruding LOCATOR male. There must be no contact between the denture and the LOCATOR cap. If the denture rests on the LOCATOR cap excess pressure on the implant will result. * symbolic illustration 8 Thommen Medical

11 5. Use a light-cure acrylic or mix a permanent self-curing acrylic to cure/bond the LOCATOR cap into the denture. Place a small amount of material in the recess of the denture and around the LOCATOR cap of the processing male. 6. Insert the denture into position in the oral cavity. Guide the patient into occlusion, maintaining a proper relationship with the opposing arch. Maintain the denture in a passive condition, and prevent any movement of the denture, while the acrylic sets. Excessive occlusal pressure during the setting time may cause tissue recoil against the denture base and could contribute to dislodging and wear of the nylon males. 7. After the acrylic resin has cured, remove the denture and discard the white spacer. Use a burr to remove excess acrylic, and polish the denture base before selecting and installing the appropriate resilient nylon male based upon number of implants and patient s preference for retention. Thommen Medical 9

12 8. Use part A of the LOCATOR core tool (art. no. 8393) to remove the black processing male from the LOCATOR cap. A Part A is released from the centre of part B with two full turns counter clockwise, such that a gap is visible in between. B To remove a LOCATOR male replacement from the titanium metal housing simply insert the tip (part A of the LOCATOR core tool) into cap/male assembly and push straight in. The sharp edge of the tip will grab hold of the nylon male and allow you to pull it straight out of the cap. A B To discard the nylon male from the tip (part A of the LOCATOR core tool) on the core tool just tighten the tip clockwise back onto the core tool this will activate the removal pin and dislodge the nylon male from the tip end. A B 10 Thommen Medical

13 9. Part B of the LOCATOR core tool (art. no. 8393) is used to firmly push a LOCATOR male replacement into the LOCATOR cap. The male replacement must seat securely into place, level with the rim of the cap. Note Do not use Part A of the LOCATOR core tool to install new male replacements: this will destroy them. The male replacement will not stay on the tool when it is turned upside down due to varying retention values of male replacements available. It is best to hold the denture with the base side down and snap the male into the LOCATOR cap. 10. Instruct the patient in the path of insertion. Have the patient insert and remove the appliance several times. Thommen Medical 11

14 LOCATOR male replacement by the dental technician Dental technician 1. Insertion of the proper LOCATOR abutment at tissue level must be completed (see page 6 placement of the LOCATOR abutment ) before beginning the following impression procedure. Note The impression must be made with an elastomer impression material (polyvinylsiloxane or polyether rubber). Hydrocolloids are not suitable for this application. 2. Place a LOCATOR impression coping (art. no. 8505) with black processing male onto each LOCATOR abutment. * Note An alternative reline impression technique using the patient s prosthesis is possible with use of the LOCATOR black processing male (part of the LOCATOR male processing package, art. no package or separate as a package with 20 pieces, art. no ). When the impression is withdrawn, the processing male will remain on the abutment. Remove the processing male from each abutment and snap it onto a LOCATOR female analog. Reposition this assembly back into the impression (LOCATOR cap) making sure it is fully seated. Pour the master cast. 3. Insert LOCATOR analogs into each impression coping and pour the master cast. Upon separation, the LOCATOR analog is a part of the master cast replicating the position of the LOCATOR abutment in the oral cavity. 4. Before waxing and processing the appliance, place white block-out spacers and LOCATOR caps with black processing male on each analog. Make sure the male is fully seated. * * symbolic illustration 12 Thommen Medical

15 5. Set the teeth and wax the appliance. Proceed with the processing technique of your choice through the boil-out step. 6. After the boil-out, remove the processing male. Place a white blockout spacer over the head of each analog. The spacer is used to block out the immediate area surrounding the LOCATOR abutment. The space created will allow the full resilient function of the pivoting LOCATOR cap over the LOCATOR male. 7. Reinsert the LOCATOR black processing male into each analog, leaving the white block-out spacer beneath it. The black processing male will maintain the overdenture in the upper limit of its vertical resiliency during the processing procedure. 8. Complete the processing and discard the white block-out spacer. Avoid damage to the final male by polishing the denture base before changing to the final male. Use part A of the LOCATOR core tool (art. no. 8393) to remove the black processing male from the LOCATOR cap (see page 14, How to change the LOCATOR male ). 9. The prosthesis is polished without the final replacement male inserted. Soiling and damage to the final male replacement is thus avoided. 10. Part B of the LOCATOR core tool (art. no. 8393) is used to firmly push a LOCATOR male replacement into the LOCATOR cap. The male replacement must seat securely into place, level with the rim of the cap (see page 14, How to change the LOCATOR male ). Note The male replacement will not stay on the tool when it is turned upside down due to the varying sizes of males available. It is best to hold the denture with the base side down and snap the male into the LOCATOR cap. Thommen Medical 13

16 How to change the LOCATOR male replacement 1. The LOCATOR core tool (art. no. 8393), which contains a part A for the male removal and a part B for the male seating, is used to remove the nylon male from the LOCATOR cap and replace it with another LOCATOR male replacement. A Part A is released from the centre of part B with two full turns counter clockwise, such that a gap is visible in between. B To remove a LOCATOR male replacement from the titanium metal housing simply insert the tip (part A of the LOCATOR core tool) into cap/male assembly and push straight in. The sharp edge of the tip will grab hold of the nylon male and allow you to pull it straight out of the cap. A B To discard the nylon male from the tip (part A of the LOCATOR core tool) on the core tool just tighten the tip clockwise back onto the core tool this will activate the removal pin and dislodge the nylon male from the tip end. A B 14 Thommen Medical

17 2. Part B of the LOCATOR core tool (art. no. 8393) is used to firmly push a LOCATOR male replacement into the metal LOCATOR. The male replacement must seat securely into place, level with the rim of the cap. Note The male replacement will not stay on the tool when it is turned upside down due to the varying sizes of males available. It is best to hold the denture with the base side down and snap the male into the LOCATOR cap. Thommen Medical 15

18 Reline and rebase 1. Remove each existing nylon male from its LOCATOR cap following the steps in how to change the LOCATOR male. Replace them with black processing male replacements. The built-in spacer of the black processing male will maintain the overdenture in its upper level of vertical resiliency during the reline process. 2. Take a reline impression using the existing overdenture as a tray. The black processing males will engage the LOCATOR abutments and hold the prosthesis in place while the impression material sets. 3. When the impression is withdrawn, the black processing male replacements will remain in the LOCATOR caps. 4. Snap a LOCATOR analog (art. no. 8516, 5.0 mm, or art. no. 8530, 4.0 mm) onto each black processing male and pour a master model. 16 Thommen Medical

19 5. After processing the reline and polishing the denture base, replace the black processing males with the final LOCATOR male replacements. Thommen Medical 17

20 Product overview PF 3.5 mm PF 4.0 mm PF 4.5 mm PF 5.0 mm PF 6.0 mm LOCATOR abutment, Titanium alloy Collar height 0.73 mm mm mm mm mm mm mm LOCATOR male processing package, Quantity per pack: 2 sets, Titanium/Nylon The set contains 1 LOCATOR cap with male processing, black ( ) 1 LOCATOR block-out spacer (8514) 1 LOCATOR male replacement, clear (8524) 1 LOCATOR male replacement, pink (8527) 1 LOCATOR male replacement, blue (8529) LOCATOR male processing package, for extended range Quantity per pack: 2 sets, Titanium/Nylon The set contains 1 LOCATOR cap with male processing, black ( ) 1 LOCATOR block-out spacer (8514) 1 LOCATOR male replacement green (8547) 1 LOCATOR male replacement orange (8915) 1 LOCATOR male replacement red (8548) LOCATOR male replacement, 4 pieces, Nylon Retention value Color 5 lbs. clear 8524 light 3 lbs. pink 8527 extra light 1.5 lbs. blue 8529 LOCATOR male replacement, for extended range, 4 pieces, Nylon Retention value Color 4 3 lbs. green 8547 light 2 lbs. orange 8915 extra light 0.5 lbs. red Thommen Medical

21 LOCATOR core tool, Stainless steel 8393 LOCATOR impression coping, 4 pieces, Aluminum/LDPE 8505 LOCATOR analog, 4 pieces, Aluminum 4.0 mm mm 8516 LOCATOR parallel post, 4 pieces, LDPE 8517 LOCATOR angle measurement guide, Stainless steel Width Height 50.0 mm 15.0 mm 9530 LOCATOR male processing, black, 20 pieces, Nylon LOCATOR block-out spacer, 20 pieces, Teflon 8514 LOCATOR insert, for handpiece and for short MONO insertion device, Stainless steel Length 23.0 mm mm 8914 Thommen Medical 19

22 Headquarters Subsidiaries/National Distributors Austria Benelux Canada China Finland France Germany Italy Japan Middle East Poland South Korea Spain/Portugal Switzerland Taiwan USA Fo_02d /14 canarini communications 1250 SWISS PRECISION AND INNOVATION.

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