WARNING: Top Implant products are intended for use by adequately trained, certified dentists with specific training in the use of Top Implant products.
All devices are for prescription use only

Safety

Indications for Use
TOP IMPLANTS products are intended for replacement of a root of a missing tooth as part of a dental restoration procedure.
"Top Implants Products" combine dental implants, Abutments, Ball attachments Healing cap, Transfer and surgical equipment.

Contraindications

• Cardiovascular disorders associated with high endocarditic risk (SBE).
• Coronary insufficiency
• Blood dyscrasias.
• Immunodeficiency, AIDS
• Cancers and radiation of the facial region in the past five years
• Respiratory disease
• Thyroid or parathyroid disease
• Patients with nodular enlargements, or inexplicable lumps on the head or neck region
• Bone metabolism disorders
• Diabetes
• Hypertension above 170/110 mmHg
• Drug abuse, alcoholism
• Titanium hypersensitivity
• Patients on corticosteroids, anticoagulants, anticonvulsive, and immunosuppressant therapy
• Patients with abnormal values for creatine, BUN or serum calcium
• Hemophilia
• Granulocytopenia
• Steroid use
  
• Prophylactic antibiotics
• Ehler-Danlos syndrome
• Renal failure
• Organ transplantation
• Fibrous dysplasia
• Organ transplantation
• Inadequate bone mass.
• Residual infections and inflammations occurring around implant
• Poor oral hygiene
• Hypersensitivity to components of the implant
• Unrealistic patient expectations
• Periodontal diseases

POSSIBLE UNDESIRABLE SIDE EFFECTS

Possible undesirable side effects associated with the use of dental implants might include: the lack or loss of integration, dehiscences that require guided bone regeneration, perforation of the mascellar and/or nasal sinuses cortical, the vestibular and/or palate/lingual cortical, the lower mandibular border, the lower alveolar canal, infected abscesses, fistulae, suppuration, inflammations, radio transparency, persistent pain, numb nerve lesions, paraesthesia, anaesthesia, hyperaesthesia, a loss of bone that requires additional intervention, implant fracture.

Hygiene and Care of the Implant

The useful life of the implant is directly dependent on the state of the oral cavity. A patient should be aware of how to maintain oral hygiene. It is recommended that the patient should periodically visit the doctor's office for inspection and professional cleaning of the implant

Surgical Drills

Rinse drills with water for two and a half minutes. Use a 25-gauge needle to clean the lumen, while continually flushing water through the needle. Sonicate for 10 minutes after cleaning the instrument with an ultra sonic cleaner and enzymatic detergent. Rinse with tap water for three minutes.

Drilling Procedure

After good surgical exposure of the bony surface, the position for the implant should be determined and a guide hole should be made using our round-head burr, taken down into the cortical bone to the level of the neck beneath the burr head.
Do not attempt to drill deeper with the round burr. Using the guide hole for position, the color-coded drill bits will be utilized to drill the hole to the desired depth.

IMPLANTS

Shark Implants

General Description
Shark Implants are formed with converging threads that originate from two different points on the implant body.
The dental implant body itself has three cones and variable thread design:

• The main part of the implant has a cone that is angled depending upon its length.
• The cone of the external thread track is angled at between 90 – 180° to the main implant body cone.
• The final cone is located on the neck of the implant and is formed from two fine threads which broaden to form a cone dependent on the diameter size of the implant.
• The internal hexagon is 2.2mm deep and formed with an internal thread of 2.5mm for fixing the abutment and super abutment units

Dimensions
Shark implants are supplied in the following dimensions:

Diameters	3.5, 3.8, 4.2, 5.0, 6.0mm
Lengths	8, 10, 11.5, 13, 16mm

Installation Techniques

Thin Alveolar Bone

• Installation of dental implants in the maxillary anterior segment for those with low alveolar bones necessitates a bocal undercut and sinus lift.
• Inserting in a high position reduces the necessity of bone removal for those with low density bone structure.

Dense Cortical Bone
Installation of dental implants into a thin bone necessitates a sinus lift when the immediate load is applied.
Installation following Tooth Extraction
The installation of dental implants immediately following a tooth extraction is possible due to the anatomic configuration of the implant abutment.

Dolphin Implants

General Description
Dolphin dental implants contain a single cylindrical thread along the implant body.
The dental implant body itself has three cones and variable thread design:

• The implant body has a cylindrical contour, with the thread contour differing from the external implant contour.
• The neck thread is comprised of two origins which create a cone shape that broadens in correlation to the diameter size.
• The neck edge has a variable angle in accordance with the implant diameter.
• The edge of the implant apex is rounded.
• The thread broadens out as it travels from the apical edge towards the neck of the dental implant. It has a thread pitch 1.2mm (a single beginning).
• The implant neck thread starts from two places and has a thread pitch of up to 0.6mm (0.3mm per a thread).
• The edge of the implant apex is rounded to maximize placement and comfort.
• The internal hexagon is 2.43mm deep and formed with an internal thread of 2.2mm for fixing the abutment and superstructure members 1–72".

Dimensions

Diameters	3.3, 3.8, 4.2, 5.0, 6.0mm
Lengths	8, 10, 11.5, 13, 16mm

Installation Techniques

Dolphin implants are specially designed for treatment involving immediate placement and immediate loading.
Dense Alveolar Bone
Installation of Dolphin dental implants appropriate for patients with low alveolar bones where a bocal undercut and sinus lift is required.
Dense Cortical Bone
Dolphin implants are appropriate for patients with thin bone where a sinus lift is required and immediate load is applied.
Installation following Tooth Extraction
The installation of dental implants immediately following a tooth extraction is possible due to the anatomic configuration of the implant abutment.

Whale One-Piece Implants

General Information
The dental implant body has three elements:

• The main part of the implant has cylindrical contours with a thread contour that conforms to the external contour.
• The cone of the implant neck is designed for maximum connection to the soft tissue surrounding the bone.
• The cylindrical implant head has four faces and is designed for prosthetic rehabilitation. It protrudes inside the mouth above the soft tissue.
• The thread broadens out as it extends from the apical edge towards the neck of the dental implant. It has a thread pitch 1.2mm (a single beginning).
• The implant neck has a smooth, polished surface and comes in tapered or straight in designs.
• The implant head can be conical (tapered) or straight along the gum line and can be inserted flush with the gum or protruding to a height of 3mm.
• The Whale implant abutment has the following features:
  • The neck and the prosthetic abutment together form a single unit which has the benefit of preventing the formation of a gap alongside the neck of the implant.
  • This one-piece design assists the preservation of the bone and reduces both compression and contact between the soft tissue and the neck of the implant.
  • The implant abutment is solid and rigid and makes use of small diameter implants.
  • The Whale implant has the advantage of being installed in a single surgical operation.

Dimensions

Diameters	3.0 and 3.3mm
Lengths	10, 13 and 16mm

Installation Techniques

Dense Alveolar Bone
Installation of Whale dental implants is appropriate for patients with dense alveolar bones.
Thin Bone
Implantation in very thin bone when immediate load is applied.
Reduced Mesiodistal Gap
Whale implants are suitable in cases of reduced mesiodistal gap.
Installation following Tooth Extraction
The installation of dental implants immediately following a tooth extraction is possible due to the anatomic configuration of the implant abutment. Temporary implants can also be used.

ABUTMENTS

Straight Titanium Abutment

Top Implants' straight abutments are made from titanium and are available in two sizes:

• For implants with diameters of: 3.3, 3.8 and 4.2mm
• For implants with diameters of: 5 and 6mm

Characteristics

• The Straight Titanium Abutments are connected to the implant through a hex connection.
• The neck of the mount is 1.3mm wide and has a converging body with a beveled incline. Opposite this is a vertical slot which is parallel to the hexagon faces.
• A 2.5mm high hexagon inside the abutment is used to insert the implant driver and the abutment.
• A peripheral locking slot is located 1mm below the abutment bevel. A 1.72" thread titanium fastener goes through the abutment. In addition, internal tapping is used to prevent the screw from falling inside the abutment.

Aesthetical Direct Abutment

This product is similar to the Straight Titanium Abutment with the following additional elements:

• The anatomically configured abutment neck has ascending and descending shoulders.
• The height of the neck varies between 1 to 4 mm and is available in four different sizes.
• There is the option of different peripheral contact rings being provided in the upper third of the abutment. This tightens the superstructure to prostheses such as copings, healing caps or temporary coronas.

Abutments come in 15 and 25° angle configurations.

Angular Abutments

Top Implants' angular abutments are made from titanium and are available in two sizes:

• For implants with diameters of: 3.3, 3.8 and 4.2mm
• For implants with diameters of: 5 and 6mm

Characteristics

• The abutment neck has an anatomic configuration with ascending and descending shoulders.
• The height of the neck varies between 1 and 4mm and is available in four different heights. The body converges at an angle of 15 or 25° with an option of peripheral ring for fixing prosthetic superstructure members.
• The driver of the tightening screw starts above the anatomical shoulder of the abutment wall.
• A short-head tightening screw with the added benefit of internal tapping is used to prevent the screw from falling inside the abutment.

Coping

Characteristics
Top Implant's coping is available in four designs:

• In a configuration that matches the conducting abutment
• In a straight anatomical configuration
• In an angular configuration of 15°
• In an angular configuration of 25°

Plastic Healing Caps

Top Implants plastic healing caps are made from Derlin 500 and are available in four designs:

• In a configuration that matches the conducting abutment
• In a straight anatomical configuration
• In an angular configuration of 15°
• In an angular configuration of 25°

Dental Implant Molds

Top Implants molds have been designed for abutments engraved in a dental laboratory. They can also be used with screw-on coronas made from noble metals, which are resistant to corrosion and oxidation.
The dental implant molds are made from Derlin 500 and are made in four designs, each of which comes in two sizes:

• Derlin 500 body with a hexagon,
• Derlin 500 body with a fixed connection and a titanium tightening screw
• Derlin 500 body with a titanium connector with a hexagon tightening screw
• Derlin 500 body with a titanium connector with a round, titanium tightening screw.

Implant Ball Connectors

The ball connectors are made from grade 5 titanium and are supplied in two designs:

• For two coronas for a wide and narrow platforms,
• Available at five heights between 0 and 7mm,

Coating Heads

The dental implant coating heads are made from grade 5 titanium and have the following characteristics:

• They integrate with the bone in two places; on a wide platform of 4.5mm and/or of 3.8 mm.
• The length of the screw is 6 mm and it has a thread of 1-72" as well as a round coating head.

Healing Caps

The healing caps are made from grade 4 titanium and are designed for covering the implant during recovery. They have the following characteristics:

• A design that amalgamates with the bone before or after the implant exposure,
• Merges with the soft tissue after the recovery period in two places,
• Is suitable for a wide platform of 4.5mm and/or 3.8 mm,
• The length of the screw is 6 mm and it has a thread of 1-72",
• Is finished with a round coating head for maximum comfort and fit,
• There is a 1-72" hexagon at a depth of 1.5 mm at the centre of the healing cap.

Comparable Healing Cap Products

• A 303 stainless steel piece with cylindrical external configuration containing three beveled areas and two peripheral slots for retention and prevention of rotation in plaster.
• The hexagonal internal area fits two types of implant platform; the narrow fitting being 3.8mm and the wide fitting measuring 4.5mm.
• An analog matching the aesthetic abutment. The body matches the implant in a similar way to that of internal tapping. It has a connection screw of gold coping at its edge.

Connection Abutments

The connection abutments are made from 5 grade titanium and match two platform sizes.
Connection Abutment Features:

• A hexagonal neck of a conical abutment at a height of 0.5mm, 1.5mm and 2.5mm,
• Forms a peripheral shoulder in the conically beveled abutment body at the hexagonal abutment neck level.
• Is fitted to the internal part of the implant, tightening the aesthetic abutment to the implant. The screw head is external to the abutment at a height of 15mm with internal tapping to the screw of the corona connection.

Plastic Heads

The dental implant plastic heads are designed for aesthetic Derlin 500 abutments and have the
following features:

• A standard screw abutment system.
• The system matches two implant platforms and is connected to the implant at a height of 1-72 without HEX.
• The conical abutment neck is at a height of 0.3mm.
• The body shape is cylindrical with a diameter of 4mm and variable height from 2 to 5 mm.
• The titanium connection screw has a head at a height of 2.2 mm and a diameter of 2.9mm The hex implant in the upper part has a width of 1.25mm.

Symbols Appearing on the Label

Symbol	Meaning
	Gamma ray sterilization
	Do not reuse
	Attention, read the attached instructions
	Expiration Date
LOT	Lot Number
	CE Mark

Sterilization

Clinically contaminated implants should not be cleaned and re-sterilized under any circumstances. Do
not autoclave hard plastic items, which can melt at approximately 338°F (170°C). Cold sterilize these
items according to manufacturer's recommendations then rinse thoroughly with sterile distilled wate r.
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Instructions for Maintenance of Surgical tools

Proper maintenance of surgical tools is extremely important. Damage to drill tips can cause significant impairment of drill function. Following are detailed instructions for proper maintenance.

Instructions for Maintenance of Surgical Tools Prior to First-Time Surgical Use

Stage 1: Light Cleaning and Rinsing – Surgical tools should be dipped in detergent, rinsed, and dried.
Stage 2: Sterilization – Drills should be sterilized in an autoclave at 135 º C /275º F for up to a maximum of 5 minutes, minimum 3 minutes.
Stage 3: During Use - Surgery tools should be soaked in a sterile saline solution until the cleaning stage.

Instructions for Cleaning and Storage of Surgical Tools after Use

Stage 1: Cleaning – Surgical tools should be brushed with detergent to remove any remaining blood or tissue.
Stage 2: Ultrasonic Cleaning – Surgical tools should be cleaned in an ultrasonic bath with appropriate detergent.
Note: During ultrasonic cleaning, contact between surgical tools should be avoided.
Stage 3: Rinsing – Surgery tools should be rinsed under running water and dried.
Stage 4: Lubrication (Required if more than 4 weeks of storage is expected) – Surgical tools should be soaked for 10 seconds in dental oil, and then removed from solution and left to dry for 30 seconds without rinsing or towel drying, and then placed in surgical kit.
Stage 5: Sterilization – Surgical tools should be sterilized in an autoclave at 135ºC/275ºF for minimum of 3 minutes.
Stage 6: Storage/Use – At this stage, kits are ready for long-term storage; they can be used immediately upon opening the kit.

Recommendations

Cutting tools should be used for a maximum of 30 cycles.
Distilled water should be used in order to avoid surface stains

Storage

Implant devices should be kept at room temperature. For special instructions for optimal preservation and treatments, refer to each product's label.