The procedures and guidelines presented in these pages areneither a substitute nor replacement for formal training. The judgment, skill,and training required to place and restore dental implants is complex. Formaltraining in surgical placement and prosthetic restoration of the ULTRATOOTH™, aSargon® Implant System technology (collectively “ULTRATOOTH™”) is arequirement. All Sargon Implants are trademarked as ULTRATOOTH™ and manufacturedand distributed by BIODENT™. FDA-Device Registration No: 2085360. This productis 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 isperhaps the most important aspect of the implant treatment process. If thepatient has not had a physical evaluation within two (2) years, a completemedical evaluation is recommended. Additionally, a comprehensive healthquestionnaire 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 intermediaryabutment(s) for xed or detachable prostheses, and for use in support offreestanding restorations with or without the involvement of adjacentdentition.

CONTRAINDICATIONS

General Medical Contraindications:

Customary general contraindications associated with electivesurgery should be observed. These include, but are not limited to: signi can’tvascular impairment to the implant site; metabolic bone disease; clottingdisorders; current treatment with therapeutic agents that may have an effect onthe surgical site, surrounding tissue, or normal healing responses (i.e. drugtreatment, anticoagulant therapy); or other metabolic or physical disordersthat 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 surroundthe implant with at least one millimeter of bone, both buccally and linguallyto 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 ofbone, and injury to the neurovascular structures.

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

• BIODENT™ Implants are intended to be used only with thespecifically designed bone drills and surgical instrumentation provided in theBIODENT™ Surgical Kit. Additionally, BIODENT™ abutments and prostheticattachments must be seated completely and radiographs should be taken to verifythe 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 alteredin any way. They are designed for use with the BIODENT™ System abutments andattachments supplied only by BIODENT™. Abutments and attachments supplied byother companies might not be made to the exact specifications and standards ofthe BIODENT™ System, and use of them may lead to implant failure, implantabutment failure, prosthesis failure, and /or loss of bone. The use ofelectro-surgical or certain laser instruments around metallic implants andtheir abutments is discouraged due to the electric and/or heat conductivity ofthe substrate metal.

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

• If the implant becomes contaminated in any way, theimplant must not be used. The implant must never be cleaned or re-sterilizedfor 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 withblood, bone, tissue, body fluids or other contaminants may lead to patient oruser injury. Possible risks associated with reuse of a single use deviceinclude, but are not limited to, mechanical failure and transmission of infectiousagents.

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

PRECAUTIONS

The surgical techniques required to place endosseousimplants require highly specialized and complex procedures. Although thesetechniques are described in the Sargon Technical Manual, formal training inplacement of such implants is strongly recommended. Practitioners should attendstudy courses to prepare themselves in established techniques of oralimplantology. It is essential to determine the local anatomy and suitability ofthe available bone. Adequate radiographs and Tomograms, direct palpation, andvisual inspection of the prospective implant site are necessary prior toimplant treatment. A Cad –generated surgical guide is highly recommended.

DEVICE DESCRIPTION

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

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

Ultratooth™

The Ultratooth™ is a one -piece implant and abutmentcombination includes:39XXUTX implant, 3965UT screw cap,3970UT UT Carrier,7160UTUT abutment screw and 7045UT UT provisional Abutment There is noabutment/implant interface to leak, cause irritation or loosen. A Prep -ableextension abutment can be used when additional retention for a toothrestoration is desired. Impression techniques are identical to those of the immediatefixed abutment (IFA). With the Ultratooth™ an optional impression post can beused for transfer purposes. This economical approach to single tooth immediateloading 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 toCUS/TRN10 for details on Ultratooth™ Handbook for specification, placement andrestoration.

BIODENT™ Non -Expandable Implant

A non -expandable (screw type) line of implants is availablewith internal connection abutment system. These come in 8,10,13,16 mm lengthsand 3.8 diameter. The Non - expandable Is a one -piece implant and abutmentcombinations 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 THETHREADED AREA AND DO NOT INCLUDE THE HEAD PROTION OF THE IMPLANTS SINCE THEHEAD AND COLLAR OF THE IMPLANTS CAN BE PLACED BELOW BONE LEVEL ADDING TO THELENGTH OF THE IMPOLANT. PLEASE MAKE SURE ANY MEASUREMENT IS MADE FROM THECORRECT PART OF THE IMPLANT DURING PLACEMENT SINCE IMPROPER MEASURMENT COULDCAUSE THE IMPLANT TO BE PLACED DEEPER THAN NECESSARY CAUSING GENERALPERFORATIONS AND NERVE DAMAGE IN THE MANDIBLE.

NOTE: A surgical template must be used to avoid positioningerrors. Before opening the sterile packaging of the Ultratooth™ implant, placethe 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 ifnecessary. If any angulation problems exist, proceed with the standardUltratooth™ implant and custom abutments for angulation corrections.

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

STERILIZATION

All BIODENT™ Implants are provided STERILE and intended forsingle use only. The method used for sterilization is Gamma radiation. Forexpiration 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 theorder of a licensed physician or dentist.

SURGICAL PLACEMENT PROCEDURE:

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

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

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

4. Using the 2mm diameter PILOT DRILL (catalog #4020);firstpenetrate 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 pilotdrill. 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 listedabove].

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 thecollar of the implant, use the Emergence Profile COUNTERBOREDRILL (catalog#4050). Drill to the length of the implant collar- 1mm. This drill should be usedin cases where the Ultratooth™ head portion is being placed below bone level.

8. The implant is attached to a carrier, which is held bythe implant holder in a blister pack. This design is to ensure sterility duringshipment 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 toengage the carrier to remove the implant from the holder.

9. Drive the implant in as far as needed, you may use aratchet (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 screwcap. This will lift the holder from the implant. Then Continue unscrewing toremove screw cap as well.

11. Insert the SCREWDRIVER (catalog #6005) into the head ofthe implant expansion screw and finger- turn it clockwise to draw the expansionmechanism up into the implant. As the mechanism rises, the body of the implantexpands 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 Tightlyscrew 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) ofappropriate length. For Ultratooth™ (UT) Implants you may prepare the holder asthe final abutment and install it on the implant and place a provisional crownif indicated. You can also use the holder as a transfer-type impression postand use the provisional abutment (enclosed within the implant sterile Blisterpackage)for provisionalization. The lab can prepare the holder as the finalabutment and use it to fabricate the final prosthesis.

2. Place a temporary restoration on implants that are ingood quality bone. Implant in soft bone can be left unloaded to heal. A healingcollar 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 conventionalimplants. However, the Ultratooth™ success rate can be improved by allowing forearly detection of an ailing implant through follow-up observation. By havingregular patient follow-up visits shortly after surgery, healing can be assessedand if initial stability has not been sustained, the problem can be addressedby re-expansion of the implant to 20Newton/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 inpoor quality bone density such as 3D and 4D bone without experienced evaluationof the ability of the bone to support the load. NOTE: Experience has shown that3D 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 thefloor of the sinus.

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

• DO NOT use ZOE containing cements for temporary crowns orprostheses cementation.

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