INTRODUCTION TO IMPLANOVA® IMPLANTS

The Implanova® bone-level implant system boasts a cutting-edge implant design that simplifies dental implant placement and restoration, as well as overcomes the shortcomings of existing implant systems. This design was conceptualized using various legacy implant system and developed meticulously utilizing CAD/CAM modeling and unprecedented 3D printing. The Implanova® implant system was designed to be easily adaptable by the experienced clinician, as well as effortless to learn by a new practitioner. More importantly, they are easy on patients in terms of surgical trauma and speed of healing. The Implanova® implant system is extremely intuitive and was intentionally simplified so that stock can be easily maintained by the practitioner. Implanova® implants feature a self-osteomizing and self-grafting body that is spotlighted when being placed surgically in the mouth. The apical 5 mm of most implant sizes are left machine finished, to retain its sharp cutting edges. With aggressive macrothreads and triple cutting blades on each helix, the implant creates its own osteotomy by shaving the surrounding bone as it is being placed for a perfect fit without any pressure or gaps. The self-grafting design is attributed to a smart “bone management” system, where reverse vertical flutes are present to guide bone shavings and debris apically along the body of the implant, which condenses around the apex of the implant for primary stability. The apex itself, however, is left non-cutting so as to safeguard critical anatomical landmarks. These features allow for high insertion torque, up to 70 N-cm, which indicates the implant is stable enough for immediate loading.

While apical portions of the implants are fine blasted depending on the implant length, the rest of the implants are coarse blast finished using resorbable apatitic calcium phosphate blasting media and is therefore roughened to a surface texture of 1.5 micron Ra minimum. Among the blasted portion are synchronous, progressive microthreads designed for smooth seating and sealing of cortical bone. Internal features of the implant include a universal double star attachment type and a conical Morse taper that ensures tight sealing with Implanova restorative components compatibility with Astra Tech™ Aqua components. The variable space between the widest portion of the implant and the implant mouth also allows for maximum platform switching to fit any type of prosthesis presented. Implanova® implants are available in 3 diameters – Narrow (3.5mm), Standard (4.5mm), and Long (5.5mm) – and are selected based on the available space between the two adjacent teeth and the type of prosthesis to be used. For each select implant diameter, there are as many as 5 different lengths available – XShort (6mm), Short (8mm), Medium (10mm), Long (12mm), and XLong (14mm). Implanova® implants can be placed either at the bone level as needed to allow for bone tissue to grow and envelop the implant collar during the healing stage of the operation. With the implant collar completely enveloped and secured by the newly formed crestal bone, the stability of the implant fixture will be further improved. All Implanova® implants are cross-compatible with all prosthetic parts, including abutments and healing caps.

The material constituent of Implanova® implants is grade 23 titanium alloy (Ti-6Al-4V ELI) per ASTM F136 standards. All implants are gamma radiation sterilized and have a 5 year shelf life. Implanova® implants help dentists provide patients with exceptional care by providing highly sophisticated designs and solutions. The system is sophisticated, yet is very easy to learn, very simple to place & restore, and very effortless to keep stock of. A new implant practitioner can learn and use this system with ease, as well as affordably adopt this system as a part of their services. A veteran implantologist will find this system to be very versatile and logical. The Implanova® implant system truly offers refreshing innovation and simplicity amid an established industry with longstanding legacy systems.
  1. 1. Indications for Use

The Implanova® bone level implants are intended for endosseous implantation as an artificial root structure in the mandible and maxilla. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® bone-level system, including implant fixtures, abutments, healing caps, cover screws, and retention screws, are intended for use by prescription only. Implanova® bone-level implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

All Implanova® bone-level implant fixtures are compatible with the straight type restorative components listed in the table below. This includes straight type abutments, straight type abutment screws, and straight type temporary abutments that are intended to be on Astra Tech’s OsseoSpeedTM TX 3.5S and OsseoSpeedTM TX 4.0S implant fixtures.


  1. 2. Caution

Federal law restricts this device to be sold by or on the order of a dentist.


  1. 3. Warning

Proper considerations, including (but not limited to) patient selection, local considerations, dimensional considerations, and implant selection, must be made in order to mitigate any potential adverse occurrences associated with the use of this product. Adverse occurrences may include:

  • Fractured, broken, or bent implant
  • Failure to osseointegrate
  • Significant bone loss
  • Adverse reaction due to concomitant medication
  • Perforation of inferior border of mandible, lingual plate, labial plate, inferior alveolar nerve, and maxillary sinus
  • Fracture of labial or lingual cortical plates
  • Systemic infection following local infection
  • Injury or irreversible damage to inferior alveolar and lingual nerves and arteries resulting in paresthesia/hyperesthesia/anesthesia and excessive bleeding
  • Persistent pain
  • Other pathologic conditions such as: infection, sinus tract formation, abscess, peri-implantitis, inflammation, suppuration, decreased density, and/or volume of hard and soft tissue structures
  • Aspiration and/or ingestion of small components
  • Unintended soft tissue damage

Adequate oral hygiene must be performed by the patient in order to maintain proper performance of the dental implants. Prior to performing any surgical operation, the clinician must properly sanitize and sterilize all devices that will be used in contact with or near the osteotomy site. Failure to carefully follow instructions could potentially result in implant failure and/or patient harm.

The Implanova® implant system has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The Implanova® implant system has not been tested for heating or migration in the MR environment.


  1. 4. Sterilization
  • The Implanova® dental implant fixtures, which are cleaned and sterilized with gamma irradiation, are ready to use. Sterile packages should be opened onto a sterile field and handled with sterilized tools only. Do not re-sterilize. Do not use if package has been opened, damaged, or expired.
  • The Implanova® cover screws, healing caps, abutments and screws are provided non-sterile and must be sterilized prior to use. Follow the sterilization recommendation presented in the table below.

  1. 5. Local Considerations

Use of periapical radiographs, panoramic surveys and 3D Cone Beam Volumetric Tomography (CBVT) is indispensable in planning for dental implants. Presence of infection in the area that the implant is contemplated must be evaluated. Chronic infection in an implant site decreases the chance of timely osseointegration due to lowered pH. Quality and quantity of the bone in the proposed site must be adequate to hold the implant motionless during the healing period in spite of the fact that day to day function of speech and mastication will resume on or near the new implant within hours following the surgical placement. The clinician may consider surgical removal of infection and/or root tips and bone grafting the area for a period of 6-12 weeks before attempting placement of the implant fixture.


  1. 6. Dimensional Considerations

Implanova® implants are specifically designed to take full advantage of the common shape of residual alveolar ridges in maxilla and mandible to provide larger surface area for osseointegration. In general, the wider and/or longer an implant, the larger surface area it provides for osseointegration. For length: Using periapical, Panoramic or CBVT imaging technology the longest implant that would not encroach on sensitive anatomic structures like the inferior alveolar nerve, mental nerve, nasal or sinus cavities can be chosen. For width: For bone stability, at least 1 mm of bone is needed in the buccal and lingual sides of each implant.

As a rule, a medium length (10 mm) standard diameter (4.5mm) implant would serve most of clinical situations. Narrower and longer OR wider and shorter implants can be selected when the width OR length of available bone is limited.


  1. 7. Selection of implant

The Implanova® implant system is designed to be simple to learn and easy to keep stock of. Dental implant fixtures are designed for single use only.  There are two fixture types, each having their own unique advantages.

Bone-level implants are designed to be seated at the bone level and are indicated in high esthetic demand areas to control emergence profile and prevent metal hue show through and/or where the implant needs to be embedded during healing. Bone-level implants are available in three diameters and five lengths (with an exception of the narrow and wide implants). All Implanova® bone-level implants are fully compatible with any Implanova® bone-level Abutments, which allows 90 different fixture-to-abutment combinations.


  1. 8. Complications
  • Pain and post-operative swelling are common consequences of surgery. Application of ice over the area of surgery and avoiding movement in the area of surgery will minimize the swelling and pain.  Non-steroidal Anti-inflammatory and analgesic medications alone or in combination with appropriate Opiates may be used to control post-operative pain and swelling.
  • Due to ever presence of bacteria in the mouth, there is a greater chance of infection in absence of antibiotic coverage following any oral surgery. It is recommended to routinely give proper antibiotic regiment covering the gram-positive bacteria following any oral surgery.
  • Rarely allergic reaction might occur to local anesthetics. Thorough history must be taken to avoid use of such this complication.
  • Some bleeding may occur as the local anesthesia wears out.
  • Failure in osseointegration may be indicated by infection, loosening of the implant fixture, or significant bone loss near the osteotomy site. All failed implant fixtures should be immediately removed from its osteotomy site. Remove any residual granulation of adjacent tissue from the osteotomy site upon fixture removal.
  • Use of dull or improper drills or instruments at the time of osteotomy may cause implant failure.
  • Patients with para-functional habits may be in greater risk of implant failure.

  1. 9. Preparation for implantation

Pre-operative diagnosis record must be completed before the surgical appointment. Periapical radiographs or panoramic survey must be used in addition to 3-D cone beam survey of the recipient site.  The space for intended implant must be evaluated in 3 planes using the above survey.  Esthetic and prosthetic expectations must be considered in choice of the implant for that site.  Patients must be prepared to rest and follow the other post-operative instructions after the implant placement.


  1. 10. Anesthesia and pain control

Implanova® implants can be inserted using standard infiltration or block local anesthesia protocols commonly practiced in dentistry. Use of 1:100,000 epinephrine is recommended for enhanced anesthesia and haemostatic effect if not contraindicated. When desired and indicated a light sedation can be used for anxiolysis. Oral non-steroidal anti-inflammatory pain medications can be used post operatively alone or in combination with a narcotic pain medication as appropriate for the clinical situation and patient’s level of discomfort.


  1. 11. Soft tissue incision

In case of previously extracted teeth, the bone surface must be exposed by a full thickness incision. When needed, the incision can be so placed as to bring some keratinized gingiva from the lingual to the buccal area.

Alternatively, the implant site can be conservatively exposed by either a biopsy punch or by a soft tissue laser to a diameter slightly larger than the width of the planned implant. Care must be taken so that all soft tissue and periosteum is removed so that they do not get interposed between the implant and bone, preventing osseointegration.


  1. 12. Implant Osteotomy

IMPORTANT:  If the bone type is very hard, enlarge the osteotomy by progressively increasing the drill bit size until implantation is feasible. Please note that the exact size of the core osteotomy is not preset, but is dependent on the consistency of the existing bone.  An increase in bone hardness will require a larger osteotomy, while softer bone will not require any additional osteotomy. The final size of the body is not very critical because it is the implant itself that is creating the final osteotomy.

NOTE: Pilot hole is drilled to the full length of the intended implant using the markings on the drill bit. First marking from the tip for XShort (6 mm), second marking for Short (8mm), beginning of third marking Medium (10mm), end of third marking Long (12mm) and fourth marking XLong (14mm). Please note that bone-level placement requires adding 1-2 mm to the depth of the pilot/core drill.

The head drill is marked for placement levels, with the length of the cutting portion used for crestal placement.

Each set of body-head drill can be used as single drills for their corresponding diameter. Alternatively, the narrow drills can be used before the standard drills and both narrow and standard drills can be used before the wide drills. Clinicians must use their best judgment to configure the appropriate sequence to minimize trauma to the bone and stay the course of the implant direction.

  • Narrow-diameter implants: Narrow-Medium (3.5x10mm), Narrow-Long (3.5x12mm) , Narrow-XLong (3.5x14mm) 
  • Use short/long round bur in high speed to mark the position of the intended implant.
  • Using the Narrow pilot drill bit, place the drill tip of the bit in the marked spot and hold the long axis of the drill buccolingually and mesiodistally in line with the axis of the proposed osteotomy.
  • Use 1200rpm with saline irrigation to create the pilot hole up to the desired length of the intended implant plus desired bone-level depth.
  • Remove the drill bit and place the Narrow Depth Gauge in the osteotomy and verify the depth and direction by an X-ray.
  • Use the Narrow core drill bit again to make any correction in the path if necessary.
  • Using the Narrow Head Drill, follow the path of the pilot hole to create the cervical osteotomy to the depth of the drill, drilled up to the marking representing the desired level.
  • The osteotomy is now ready to receive a Narrow diameter 3.5 mm implant.
  • Standard-diameter implants: Standard-Short (4.5x8mm), Standard-Medium (4.5x10mm), Standard-Long (4.5x12mm), Standard-XLong (4.5x14mm)
  • Use short/long round bur in high speed to mark the position of the intended implant.
  • Using the Standard pilot drill bit, place the drill tip of the bit in the marked spot and hold the long axis of the drill buccolingually and mesiodistally in line with the axis of the proposed osteotomy.
  • Use 1200rpm with saline irrigation to create the pilot hole up to the desired length of the implant.
  • Remove the drill bit and place the Standard Depth Gauge in the osteotomy and verify the depth and direction by an X-ray.
  • Use the Standard Pilot Drill to make any correction in the path if necessary.
  • Using the Standard Head Drill, follow the path of the pilot hole to create the cervical osteotomy to the depth of the drill, drill up to the marking representing the desired level. (For X-Short 6 mm implants, use the special implant drill for X-Short implants)
  • The osteotomy is now ready to receive a Standard diameter 4.5mm implant.
  • Wide-diameter implants: Wide-Short (5.5x8mm), Wide-Medium (5.5x10mm), Wide-Long (5.5x12mm)
  • Use short/long round bur in high speed to mark the position of the intended implant.
  • Using the Wide pilot drill bit, place the drill tip of the bit in the marked spot and hold the long axis of the drill buccolingually and mesiodistally in line with the axis of the proposed osteotomy.
  • Use 1200rpm with saline irrigation to create the pilot hole up to the desired length of the implant.
  • Remove the drill bit and place the Wide Depth Gauge in the osteotomy and verify the depth and direction by an X-ray.
  • Use the Wide Pilot Drill again to make any correction in the path if necessary.
  • Using the Wide Head Drill, follow the path of the pilot hole to create the cervical osteotomy to the depth of the drill, drilled up to the marking representing the desired level. (For X-Short 6 mm implants, use the special implant drill for X-Short implants)
  • The osteotomy is now ready to receive a Wide diameter 5.5mm implant.

  1. 13. Implant fixture installation
  • Implanova system implants can be driven using a manual torque wrench (recommended) or a motor driven hand-piece using 10-15 rpm in absence of irrigation with 40 Ncm torque. Bone-level implants will require a bone-level implant mounting tool for implantation. All-In-One implants will require an abutment mounting tool for implantation.
  • Carry the selected implant with the appropriate mounting tool to the osteotomy site and start the rotation until the implant is seated in its final position. Occasionally, depending on the type bone involved, it might take more than 40 Ncm of torque for the implant to seat completely. In this case, a manual torque wrench should be used to further drive the implant into its place. Forces which are greater than 70 Ncm must not be used under any circumstances. Implanova implants can be safely placed by up to 70 N-cm force without any risk of necrosis. The Implanova implant Carrier is rated up to 90 N-cm. The implant driver features a standard hex on its body that is engaged when used with our ratchet adapter or with surgical hand pieces that are equipped with this feature. Unless this body hex is engages, the implant driver’s ISO latch may not withstand forces beyond 40 N-Cm.

SecureClickTM Implant Driver

IMPORTANT: If the implant is not driven home by 70Ncm force, it has to be removed and the core osteotomy must be enlarged. The implant can then be reinserted into place to arrive at the desired depth.

IMPORTANT: Please remember that Implanova implants cut their own osteotomy as they are being seated. Therefore, firm downward pressure is necessary to drive the implant home. Also, the implant must be rotated as slowly as possible with the motor and/or torque wrench.

  • The osteotomy site should be allowed to heal once the implant is secured. Use the following guidelines for installing healing and restorative components:

Bone-level implants:  Either a cover screw or a healing abutment should be placed manually with a torque of no more than 10 Ncm (finger pressure).  The platform diameter of the selected healing abutment must match the platform diameter of the intended abutment. Different neck lengths are available for different placement levels (short neck for crestal placement, medium neck for bone-level placement, and long neck for way bone-level placement). If a cover screw is used, the gingival tissue is allowed to heal over the healing cap, and a subsequent removal the overlaying mucoperiosteum will be necessary to expose the implant for abutment placement. If healing abutments are selected for use, the adjacent mucoperiosteal flaps should be positioned around the neck of the healing abutment and properly sutured together.

NOTE: All three healing abutments, narrow, standard and wide and three abutment platforms narrow, standard and wide fit all three implant diameters (narrow, standard, and wide) interchangeably. Due to the cone lock mechanism of this system, it may become difficult to remove a healing cap/abutment that is torqued beyond 10 N-cm at the time of implant placement without risking implant displacement.

NOTE: Implanova® abutments and abutment screws must be torqued to no more than 20 Ncm.


    1. 14. Written post-operative instructions must be given to the patients with emergency contact information for the following few days.

    1. 15. Given the fact that oral environment is populated with pathogenic bacteria and disinfection of oral mucosa is NOT practical, systemic antibiotic coverage is highly recommended following dental implant placement.

    1. 15. Any sutures placed must be removed one week after the surgery and the surgical site must be inspected to ensure absence of infection.

    1. 16. Depending on the final torque that the implant was seated, the Implanova® implants can be immediate loaded or delay loaded. Ideally, it takes 6 weeks to 6 months post-insertion for complete healing and osseointegration. If immediate loading is desired, it should be attempted with caution so that not to cause any movement of the implant during the first 6 weeks. Ideally, during the first 6 weeks the implant must be spared from occlusal forces during function and para-function.

  1. The Implanova® dental implant fixtures, cover screws, and healing caps should be used within 5 years from the date of manufacture.