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27030 Malibu Hills Road, Calabasas Hills, CA 91301 USA 818-444-3333 voice, 818-444-3400 fax, www.implantdirect.com

Custom Laboratory Prosthetics Instructions For Use Caution: Federal law restricts this device to sale by or on the order of a dentist. Disclaimer of Liability: The users of Implant Direct Sybron Manufacturing, LLC. products must determine whether or not a particular product is suitable for a particular application and circumstance. Implant Direct Sybron Manufacturing, LLC. disclaims any liability, express or implied, and shall have no responsibility for any direct, indirect, punitive or other damages arising out of or in conjunction with any errors in professional judgment or practice in the use of Implant Direct Sybron Manufacturing, LLC. products. Users are advised and obliged to study the latest news and developments in implant dentistry, and to frequently review www.implantdirect.com for any updates to products and/or specifications. Implant Direct Sybron Manufacturing, LLC. has no control over the use of its products, which are the responsibility of the user. Implant Direct Sybron Manufacturing, LLC. assumes no liability whatsoever for damage arising thereof.

Do not re-use

Caution: Federal law restricts this device to sale by or on the order of a dentist.

Caution: Not sterilized

Consult instructions for use

Do not use if packaging is damaged

Caution

1: Indications For Use: Implant Direct Sybron Manufacturing, LLC.’s Custom Laboratory Prosthetics are customized devices and are intended for clinical situations for which the existing product assortment or replacement parts do not offer a feasible clinical solution. These patient-specific restorative products intended for use in partially and fully edentulous maxillary and mandibular dental arches in support of single and multiple-unit dental restorations and terminal or intermediate abutment support for fixed bridgework. 2: Training: Implant restoration involves complex procedures and should be performed by dental professionals who have received implantology training covering current techniques. Inadequate training may result in failure of the restoration and further complications. 3: Compatibility: 3.1: Custom Bars and Abutments are compatible at the implant-level with ScrewPlant, ScrewPlus, Legacy, RePlant, RePlus, ReActive, SwishPlant, SwishPlus & InterActive System implants. Custom Bars are also compatible with ScrewIndirect implants. • Legacy System: Prosthetically compatible with Zimmer Dental Tapered Screw-Vent system, BioHorizons and MIS implants. • RePlant, RePlus & ReActive Systems: Prosthetically compatible with Nobel Biocare NobelReplace tri-lobe system. • SwishPlant & SwishPlus Systems: Prosthetically compatible with Straumann Standard, Standard Plus and Tapered Effect systems. • InterActive System: Prosthetically compatible with Nobel Biocare NP & RP conical connection systems. 3.2: Custom Bars are compatible at the abutment-level with Implant Direct multi-unit abutments and Nobel Biocare multi-unit abutments. 4: Contraindications include but are not limited to: uncontrolled parafunctional habits (e.g. bruxing, clenching, gnawing), insufficient height and/or width of bone, insufficient interarch space, intraoral infection, poor or noncompliant patient oral hygiene. Implant Direct’s Custom Laboratory Prosthetics have not been evaluated for safety and compatibility in the MR environment. Implant Direct’s Custom Laboratory Prosthetics have not been tested for heating or migration in the MR environment and they are not represented to be “non-pyrogenic.” 5: Customization Parameters 5.1: Custom bars cannot be produced for cases in which implant divergence is greater than 40 degrees. 5.2: Custom abutments cannot be produced for angle corrections greater than 30° from the long axis of the implant starting no greater than 3mm above the interface. Custom abutment must have a post height of at least 4mm; the contours and dimensions must be within the parameters of our preset blanks. Blank sizes vary according to interfaces type and size. Custom abutments are covered by our 5 year limited warranty. 6: Materials: Custom Bars are made of titanium alloy (6Al-4V ELI). Custom Abutments are made of titanium alloy (6Al-4V ELI) and/or Sintered Zirconium Oxide (ZrO2)


7: Single-Use Packaging: This device is designed for Single Use Only and re-use should not be attempted. Custom products are designed for each individual patient as prescribed and should only be used for treatment of that patient. 8: Packaging: All Custom Abutments and Bars are cleaned and are packaged in a non-cleanroom environment. All Custom Laboratory Prosthetics are supplied non-sterile. Sterilization is required for all prosthetic components prior to being used intraorally. 9: Sterilization of non-sterile prosthetic components: Steam autoclave titanium parts and plastic components for 30 minutes minimum at 121째 C (250째 F), 15-20 psig. Autoclave operation times vary from unit to unit. Multiple piece products should be disassembled to individual components prior to sterilization. 10: Insertion Procedures: 10.1: Patient Information: Peel off removable label from the package and place in the patient/case records. 10.2: Bar Insertion Procedure. 10.2.1: Remove Bar & Screws from Packaging: All bars are packaged in a protective, plastic case. All screws are packaged separately in vials and mounted on a plastic screw mount. 10.2.2: Proceed with disinfection and sterilization instructions as detailed in item #9 above. 10.2.3: Try-in and Fixation: Insure the bar is passively seated by first inserting and aligning the bar, then securing fixation screws without tightening. Tighten fixations screws in a contra-lateral pattern. Apply final torque according to table below to fixation screws cross arch sequentially after verification of an accurate and passive fit. Fixation Type

Torque Value

Implant Level

30Ncm

Implant Direct Multi-Unit Abutment Level

20Ncm

Implant Direct Multi-Unit Angled Abutment Level

30Ncm

Competitor Multi-Unit Abutment Level

15Ncm*

*Always follow current instructions from corresponding manufacturer regarding torque and tools 10.3: Custom Abutment Insertion Procedure. 10.3.1: Remove Abutments from Packaging: All abutments packaged in vials are mounted on a plastic screw mount or carrier. 10.3.2: Proceed with disinfection and sterilization instructions as detailed in item #9 above. 10.3.3: Insertion: Abutments are initially seated using the corresponding driver in conjunction with the corresponding fixation screw. Abutments should then be torqued to 30Ncm, unless otherwise specified on the label, to ensure fixation between mating components. 11: Post-Restorative Care: It is recommended that patients use a suitable mouth rinse for the first 7 to 10 days following implant restoration. Subsequently, patients should perform regular oral hygiene and maintain regular dental prophylaxis. 12: Instructions : Users are advised to consult packaged instructions for use and the technical support sections of our website (www.implantdirect.com) for assistance.

Authorized Representative in Europe (Regulatory Affairs Only) Emergo Europe Molenstraat 15 2513 BH The Hague Netherlands

IFU-005 Rev-02


Custom Direct IFU