The procedures and guidelines presented in these pages are neither a substitute nor replacement for formal training. The judgment, skill,and training required to place and restore dental implants is complex. Formal training in surgical placement and prosthetic restoration of the ULTRATOOTH™, a Sargon® Implant System technology (collectively “ULTRATOOTH™”) is a requirement. All Sargon Implants are trademarked as ULTRATOOTH™ and manufactured and distributed by BIODENT™. FDA-Device Registration No: 2085360. This product is protected under one or more of the following 

U.S. Patents: 8,828,066;8,696,720; 9,055,985; 5,681,167. 

For more information, please visit:www.biodentinc.com/patents

PATIENT SELECTION and EVALUATION

Patient evaluation and selection prior to implant surgery is perhaps the most important aspect of the implant treatment process. If the patient has not had a physical evaluation within two (2) years, a complete medical evaluation is recommended. Additionally, a comprehensive health questionnaire should be completed by the patient and reviewed by the practitioner.

INDICATIONS FOR USE

The BIODENT™ System is designed for use in either partially,or fully edentulous mandibles and maxillae, as an al or intermediary abutment(s) for xed or detachable prostheses, and for use in support of freestanding restorations with or without the involvement of adjacent dentition.

CONTRAINDICATIONS

General Medical Contraindications:

Customary general contraindications associated with elective surgery should be observed. These include, but are not limited to: signi can’t vascular impairment to the implant site; metabolic bone disease; clotting disorders; current treatment with therapeutic agents that may have an effect on the surgical site, surrounding tissue, or normal healing responses (i.e. drug treatment, anticoagulant therapy); or other metabolic or physical disorders that interfere with bone growth, maintenance or wound healing.

Possible Contraindications:

• Chronic bleeding problems (blood dyscrasias)

• Certain cardiac and vascular diseases

• Chronic renal disease

• Treatment with corticosteroids

• Treatment with chemotherapeutic agents

• Metabolic bone or connective tissue diseases

• Diabetes (uncontrolled)

• Psychological impairment

• Bruxing/abnormal clenching

• Tobacco usage

• Poor patient oral hygiene

• Patients taking osteoporosis medication (ex: Fosamax,Boniva, etc.).

• Pregnant women (only as an emergency procedure)

Temporary Contraindications:

• Systemic infections

• Local oral or respiratory infections

Anatomic or Pathologic Contraindications:

• Insufficient alveolar bone width and height to surround the implant with at least one millimeter of bone, both buccally and lingually to the most superior cervical aspect of the implant body.

• High mandibular neurovascular canal 2mm proximal to the osteotomy.

• Malignancies

• Adjacent tooth infections

Warnings:

•Age: 18 years or older

• Improper techniques can cause implant failure, loss of bone, and injury to the neurovascular structures.

• No attempt should be made to alter or modify the implant body or threaded area of the abutment. Use only genuine BIODENT™ abutments to restore the Ultratooth™.

• BIODENT™ Implants are intended to be used only with the specifically designed bone drills and surgical instrumentation provided in the BIODENT™ Surgical Kit. Additionally, BIODENT™ abutments and prosthetic attachments must be seated completely and radiographs should be taken to verify the seating of all components used in the restoration phase of the implants. BIODENT™Implants are not compatible with other prosthetic systems.

• BIODENT™ implants and instrumentation must not be altered in any way. They are designed for use with the BIODENT™ System abutments and attachments supplied only by BIODENT™. Abutments and attachments supplied by other companies might not be made to the exact specifications and standards of the BIODENT™ System, and use of them may lead to implant failure, implant abutment failure, prosthesis failure, and /or loss of bone. The use of electro-surgical or certain laser instruments around metallic implants and their abutments is discouraged due to the electric and/or heat conductivity of the substrate metal.

• Implant mobility, bone loss or infection may indicate implant failure. Any implant that appears to be failing should be treated as soon as possible. If the removal of the implant is deemed necessary, unscrew the expansion screw (several reverse turns will release the tension on the expansion mechanism), and push down on the expansion screw with the screwdriver to reposition the expansion nut. Then the implant driver should be attached,and the implant unscrewed. The soft tissue should be curetted from the implant site and the site allowed to heal in the same manner as an atraumatic natural tooth extraction, grafting of bone may be performed if necessary. If the implant is partially integrated use the above procedure to remove the bone from internal surface of pods and then use a trephine drill that to the diameter of the upper portion of the implant to remove the implant. The drill will cause the legs to collapse since they no longer are supported with bone on the inside surface.

• If the implant becomes contaminated in any way, the implant must not be used. The implant must never be cleaned or re-sterilized for use in another patient. Do not attempt to decontaminate the implant by anyin-office method. Reuse of a single use device that has come in contact with blood, bone, tissue, body fluids or other contaminants may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents.

• Do not allow intra-oral procedures to transmit heat to the implant body and surrounding bone. Ample external and/or internal irrigation is necessary for cooling to prevent this type of problem.

PRECAUTIONS

The surgical techniques required to place endosseous implants require highly specialized and complex procedures. Although these techniques are described in the Sargon Technical Manual, formal training in placement of such implants is strongly recommended. Practitioners should attend study courses to prepare themselves in established techniques of oral implantology. It is essential to determine the local anatomy and suitability of the available bone. Adequate radiographs and Tomograms, direct palpation, and visual inspection of the prospective implant site are necessary prior to implant treatment. A Cad –generated surgical guide is highly recommended.

DEVICE DESCRIPTION

The Sargon Immediate Load Implant® is a root-form screw-type dental implant made from titanium alloy (Ti6Al4V). The unique design of this implant provides expansion capability at the implant’s apical end that is activated by the surgeon after placement by inserting a screwdriver into the channel of the implant and torque the expansion screw to 20 Newton cm².

The implant is assembled from three titanium parts: the implant body, the expansion screw, and the expansion cone. The implants have body diameter (3.8mm,4.8), lengths (10mm, 13mm, and 16mm) with a Hex/Bevel head for Morse Taper Seal. There is also a Screw Cap that is designed to seal the top of the implant once the implant is expanded.

Ultratooth™

The Ultratooth™ is a one -piece implant and abutment combination includes: 39XXUTX implant, 3965UT screw cap, 3970UT UT Carrier,7160UTUT abutment screw and 7045UT UT provisional Abutment There is no abutment/implant interface to leak, cause irritation or loosen. A Prep -able extension abutment can be used when additional retention for a tooth restoration is desired. Impression techniques are identical to those of the immediate fixed abutment (IFA). With the Ultratooth™ an optional impression post can be used for transfer purposes. This economical approach to single tooth immediate loading is now available in 3 lengths and two diameters: 16mm (#3916UT), 13mm(#3913UT), 10mm (#3910UT), and in 3.8 and 4.8 mm diameters. Please refer to CUS/TRN10 for details on Ultratooth™ Handbook for specification, placement and restoration.

BIODENT™ Non -Expandable Implant

A non -expandable (screw type) line of implants is available with internal connection abutment system. These come in 8,10,13,16 mm lengths and 3.8 diameter. The Non - expandable Is a one -piece implant and abutment combinations includes

38XXI Non expandable implant,

3970IC IC Carrier,

3960I IC Cover Screw

7160 Abutment screw.

See CUS/TRN 20 Non expandable Implant chart.

IMPORTANT: ALL IMPLANT LENGTHS ARE MEASURED FROM THE THREADED AREA AND DO NOT INCLUDE THE HEAD PORTION OF THE IMPLANTS SINCE THE HEAD AND COLLAR OF THE IMPLANTS CAN BE PLACED BELOW BONE LEVEL ADDING TO THE LENGTH OF THE IMPLANT. PLEASE MAKE SURE ANY MEASUREMENT IS MADE FROM THE CORRECT PART OF THE IMPLANT DURING PLACEMENT SINCE IMPROPER MEASUREMENT COULD CAUSE THE IMPLANT TO BE PLACED DEEPER THAN NECESSARY CAUSING GENERAL PERFORATIONS AND NERVE DAMAGE IN THE MANDIBLE.

NOTE: A surgical template must be used to avoid positioning errors. Before opening the sterile packaging of the Ultratooth™ implant, place the appropriate size Ultratooth™ body try -ins into the completed osteotomy.The body try -in shows the exact position of both the implant and its abutment.By using the try -in, the operator can now make a length correction if necessary. If any angulation problems exist, proceed with the standard Ultratooth™ implant and custom abutments for angulation corrections.

All Sargon Implants are trademarked as ULTRATOOTH™ and manufactured and distributed by BIODENT™.

STERILIZATION

All BIODENT™ Implants are provided STERILE and intended for single use only. The method used for sterilization is Gamma radiation. For expiration of sterility please see label on implant package.

STORAGE

To ensure implant packaging integrity, store between 20 degrees Celsius to 25 degrees Celsius

CAUTION

Federal law restricts this device for sale by or on the order of a licensed physician or dentist.

SURGICAL PLACEMENT PROCEDURE:

1. The use of a surgical guide of the doctor’s design preference is recommended to facilitate proper location and angulation of the implant.

2. Create an elevated gingival tissue flap over the implant site to expose the bone ridge.

3. With copious irrigation by sterile water (chilled if possible), mark and flatten the area with a ROSETTE DRILL (catalog #4010) to create a surgical table at the crest of the ridge. This surgical table should be at least 2mm wider than the implant. note: A radiograph may be taken with the pilot drill in place to confirm depth and direction. When placing more than one implant, place a PARALLEL PIN (catalog #6070) into the completed pilot osteotomy and proceed to the next implant site. Align the pilot drill parallel to the previous pin when available bone permits and drill the next osteotomy.

4. Using the 2mm diameter PILOT DRILL (catalog #4020);first penetrate the cortical bone, then drill into the spongy bone to a depth of 4 to5mm.

5. Place the guide portion of the GUIDE DRILL (catalog#4030) into the prepared site and drill to the same depth drilled by the pilot drill. Do not generate heat at a fast-drilling speed.

[The UNIVERSAL ONE-STEP DRILL (catalog #4085, 4085L) maybe used by sufficiently experienced surgeons to replace Steps 3-5 listed above].

6. Use the FINALDRILL (catalog #4040, #4042 or 4080 forwide) to penetrate to the line corresponding to the length of the selected implant.

7. To prepare the crestal portion of the osteotomy for the collar of the implant, use the Emergence Profile COUNTERBORE DRILL (catalog#4050). Drill to the length of the implant collar- 1mm. This drill should be used in cases where the Ultratooth™ head portion is being placed below bone level.

8. The implant is attached to a carrier, which is held by the implant holder in a blister pack. This design is to ensure sterility during shipment and storage while allowing easy placement onto the Implant Driver.After removing from the box, peel off the Tyvek cover to open the blister pack.Pull back holder from the blister pack. You may use the HAND WRENCH (catalog#6055) or IMPLANT DRIVER (catalog #6045UT) with the latch type connection to engage the carrier to remove the implant from the holder.

9. Drive the implant in as far as needed, you may use a ratchet (catalog #6051) if bone resistance indicates the need. All BIODENT™implants are self-tapping.

10. You may use the Ultratooth™ HEX DRIVER (catalog #6025UT)to unscrew and remove the implant holder from the implant. In case of Ultratooth™,the holder may still be holding onto the implant due to the friction fit.Instead of pulling it apart by force, use the same driver to unscrew the screw cap. This will lift the holder from the implant. Then Continue unscrewing to remove screw cap as well.

11. Insert the SCREWDRIVER (catalog #6005) into the head of the implant expansion screw and finger- turn it clockwise to draw the expansion mechanism up into the implant. As the mechanism rises, the body of the implant expands into the walls of the surgical site. Use the TORQUE WRENCH (catalog#6053) to tighten the expansion screw to 20 Newton/cm² (reference catalog #6053IFU for more information on the torque wrench)

12. With good bone quality and quantity, the implant Tightly screw on the screw cap on the implant after expanding the implant. This insuresa primary seal from bacterial infiltration into the implant.

SURGICAL FINISHING OPTIONS:

1. For Non-Expandable Implants: Install the HEALING COLLAR(catalog #’s 3942I, 3944I, 3942IW, 3944IW) or COVER SCREW (catalog #3960I) of appropriate length. For Ultratooth™ (UT) Implants you may prepare the holder as the final abutment and install it on the implant and place a provisional crown if indicated. You can also use the holder as a transfer-type impression post and use the provisional abutment (enclosed within the implant sterile Blister package)for provisionalization. The lab can prepare the holder as the final abutment and use it to fabricate the final prosthesis.

2. Place a temporary restoration on implants that are in good quality bone. Implant in soft bone can be left unloaded to heal. A healing collar or a cover screw can be placed on all non-expandable implants.Appropriate antibiotic coverage is recommended post-surgically.

SURGICAL FOLLOW-UP:

If the Ultratooth™ is placed without follow-up observation,it could have the same prognosis for success as do many other conventional implants. However, the Ultratooth™ success rate can be improved by allowing for early detection of an ailing implant through follow-up observation. By having regular patient follow-up visits shortly after surgery, healing can be assessed and if initial stability has not been sustained, the problem can be addressed by re-expansion of the implant to 20 Newton/cm²

Requirements:

• Do radiograph to ensure component seating.

• Always tighten the expansion screw to 20 Newton/cm/2

• Always activate the expansion mechanism.

DO NOT:

• DO NOT immediately load implants that have been placed in poor quality bone density such as 3D and 4D bone without experienced evaluation of the ability of the bone to support the load. NOTE: Experience has shown that 3D bone can often accommodate loading, while 4D bone should never be loaded immediately.Incremental loading is appropriate under these conditions.

• DO NOT immediately load implants that are involved in the floor of the sinus.

• DO NOT use any abutment system other than the BIODENT™Abutment System.

• DO NOT use ZOE (Zinc Oxide-Eugenol) containing cements for temporary crowns or prostheses cementation.

• DO NOT use any Methyl-methacrylate to provisionalize any newly placed implants, since it will cause inflammation and rejection of the implant in patients with sensitivity to Methyl-methacrylate