neoss 15347 ProActive Implants and Healing Abutments Instruction Manual

INSTRUCTIONS FOR USE
Neoss ProActive Implants and Healing Abutments
Instruction Manual

15347 ProActive Implants and Healing Abutments

Products (Product Categories):

• ProActive Implant Edge SP (1)
• ProActive Implant Straight ∅3.25 NP (2)
• ProActive Implant Straight SP (3)
• ProActive Implant Tapered SP (4)
• ProActive Implant Wide SP (5)
• Cover Screw (6)
• Healing Abutment PEEK (including Esthetic Healing abutment) (7)
• Healing Abutment Titanium (8)

DESCRIPTION

The Neoss implant system is a complete system of endosseous dental implants with corresponding instruments, prosthetic products and accessories.
For additional information on the specific Neoss Implant System product you are using please consult the following documents:
– The Neoss Implant System Clinical Handbook (10501) and translated versions.
Implants: ProActive Implants Straight ∅3.25 NP/Straight/Tapered/Edge/ ∅6.0/∅6.5
The product is a self-cutting titanium implant made from c.p. titanium with the Neoss ProActive surface. The assortment consists of different implant body designs (Straight, Tapered, Edge) in different lengths 7 – 17 mm and diameters 3.25 – 6.5 mm in order to fit different anatomical and clinical variations.
All implant dimensions ∅3.5 and larger have the same internal abutment connection (SP) independent of implant diameter. The ∅3.25 implants have a separate narrower abutment connection (NP). The internal connection is equipped with interlocking elements for an insertion tool and the nonrotational locking of the abutment.
Neoss implants all have a blasted, acid etched and hydrated surface with hydrophilic properties, the ProActive surface. The implant surface has dual surface roughness, less surface roughness on the implant collar and increased roughness on the threaded part.

The Neoss implant system has specific design characteristics for mating Neoss products such as implants, instruments, abutments, impression copings and accessories.
Cover Screws: Cover Screws are one-piece products in titanium equipped with a Neo screwdriver connection and a threaded part to allow connection to dental implants protecting the abutment connection from tissue overgrowth during healing before prosthetic delivery.
Healing Abutments PEEK and Titanium: Healing Abutments come in different variants and materials; PEEK is offered in both a cylindrical shape as well as several anatomical shapes (Esthetic with ScanPeg). PEEK Healing Abutments come with a Neo screw. Titanium one-piece products are available in different heights and an integrated Neo screwdriver connection.
For a specific product description, article number and dimensions please consult the product label and the Neoss Product Catalogue.

INTENDED USE

The Neoss ProActive implants are endosseous dental implants intended for surgical placement in the maxillary or mandibular bone as a permanent anchorage for prosthetic products that replaces lost natural teeth and restore chewing function, speech and aesthetic appearance.
Cover Screws and Healing Abutments are intended to protect the implantabutment connection from bone or soft tissue in-growth when connected to the Neoss implants or Access Abutments during healing and before prosthetic delivery. Healing abutments also support and shape the soft tissue healing as a non- loaded part during the healing period prior to delivery of the prosthetic restoration.
Implants, Cover screws and Healing abutments are intended for single use for a single patient.

INDICATION FOR USE

The Neoss implant system is intended to be used for treatment of edentulism by the replacement of one or more missing or failing teeth.

• Implants can be placed in fresh extraction sockets (immediate placement) as well as in healed sites.
• Implant can be placed using one-stage or two-stage surgical procedures.
• Immediate, early or delayed loading procedure can be applied.
• Fixed as well as removable prosthetics may be used.
• Prostheses may be single implant or splinted restorations.

Recognizing sufficient bone volume and stability and appropriate occlusal loads for the chosen procedure.
PATIENT TARGET GROUP
Adult population. Patients that have reached skeletal maturity and their jawbone is fully developed.
INTENDED USER AND CLINICAL SETTING
A licensed dental practitioner or physician will perform the clinical treatment using standardized, well-established surgical or prosthetic procedures in a hospital/clinic setting.

EXPECTED CLINICAL BENEFITS
The product is expected to fulfil its intended use in the specified indications, in its patient target group, during its expected lifetime.
EXPECTED LIFETIME OF THE PRODUCT IN FUNCTION
Implants: The patient can, if not belonging to any groups with contraindications and if product is used as intended and for correct indications, expect the dental implant treatment to restore and maintain aesthetics and/or function for at least 25 years.
Healing Abutments, Cover Screws: The patient can, if not belonging to any groups with contraindications and if the product is used as intended and for correct indications, expect the products to stay in place until replaced with abutments and restorations.

CONTRAINDICATIONS

Patients who are medically unfit for the medical procedure.
Placement of implants in insufficient numbers or sizes to support biomechanical loads or undesirable positioning is contraindicated.
Influencing factors might be narrow diameter implants, angulated abutments, posterior region, insufficient bone quality and quantity. Such an example is narrow diameter implants in combination with angulated abutments such as angulated Access Abutments in the posterior region.
Fully guided implant placement with ProActive Edge Implant, i.e. utilizing the Neoss Guide Implant Mount for placement with a stop through a guide without impression taking.
Treatment is contraindicated where the patient has a pre-existing allergy to products used for the treatment.
MATERIAL
Neoss dental implants are made of commercially pure titanium grade IV.
Healing abutments are either made of titanium alloy (Ti6Al4V) or PEEK (Polyetheretherketone).
Covers crews and Healing abutments screws are made of commercially pure titanium grade IV or titanium alloy (Ti6Al4V).
ScanPegs are made of PMMA.
STERILITY AT DELIVERY
All Dental implants, Healing abutments, and Cover Screws are supplied sterile, irradiated using Gamma, with a given expiry date as indicated by the packaging.
DAMAGED PACKAGING
If the packaging of a sterile product is damaged upon delivery the product must be disposed.

PREPARATIONS BEFORE USE

Sterile products are not intended to be adjusted before clinical use.
CLEANING, DISINFECTION AND STERILISATION
Sterile products are not intended to be processed before clinical use.

STORAGE

Sterilized bags and unused products must be stored in a dry environment at room temperature and out of direct sunlight. Unused products must be stored in their original packaging.
PROCEDURE
For detailed information on procedures for a specific Neoss Implant System product, please consult Neoss Implant System Clinical Handbook (10501).
Treatment Planning: Clinical assessment before surgery is a prerequisite for efficient and accurate treatment. Anatomical features and patient specific requirements are considered to determine implant position, number of implants, implant diameter and type. More exhaustive treatment planning measures are provided in the Neoss Implant System Clinical Handbook (10501) together with references to planning softwares.
Preparation of implant site: The Neoss surgical trays are available for specific implant types and include proposed drill sequences considering different bone qualities.
Bone preparation shall be carried out under profuse irrigation with saline and using an intermittent drilling technique. This prevents the bone from overheating and creates a pumping effect for efficient removal of bone debris. Recommended speed for drills is 800 – 2000 rpm using lower speed for larger drills. Recommended speed for countersinks is 800 rpm.
The drill preparation depth shall correspond to the implant length and the countersink to the implant diameter.

Implant placement: The implant is retrieved from the sterile implant vial with the Neoss Inserter and placed manually with the wrench adapter and the ratchet or with a machine handpiece.

The machine installation of the implant is carried out at low speed –recommended maximum of 20 rpm. Torque control can be used – a maximum of 45 Ncm is recommended.

Soft tissue closure: Prior to soft tissue closure, a cover screw or healing abutment, available in the implant packaging as per image below, is selected and tightened to the implant with 10 Ncm torque.

Post operative care: The healing period for osseointegration varies but is dependent on certain criteria:

• stability of implant at time of placement
• bone quality
• grafted bone
• overall patient health
• expected masticatory forces

The decision when to load implants should be assessed at the time of surgical placement and followed-up during healing. The Neoss System implants may be loaded at any time – immediately, 6 – 8 weeks or after such time as the surgical clinician deems appropriate based on the above-mentioned criteria and the experience of the clinician.
Provisional products used during the healing phase must be placed out of occlusion.
The patient is reviewed during the healing phase.
Implant access: In preparation for impression taking the implant is exposed by either removing the healing abutment or performing a second stage surgery to open the soft tissue to get access to the cover screw. The healing abutment or the cover screw is removed using the Neo screwdriver.
Tightening torques: Tighten the screw using the Neo screwdriver in combination with the Neoss Ratchet. Set the required torque as listed below and on the packaging of the abutment or the screw.
Neoss Implant System Torque Recommendation (Ncm)

Ti
45 Max| 10 Max| 10 Max| 10 Max

WARNINGS

The Neoss implant system should only be used by a licensed dental practitioner or physician who have had the appropriate education and training.
Implement proper radiographic examination and planning to avoid vital anatomical structures (i.e. nerves, blood vessels, teeth or other sensitive structures) during implant site preparation and implant insertion.
Because of the small size of the products, care must be taken that they are not swallowed or aspirated by the patient.

PRECAUTIONS

• Neoss implant system products should only be used together with original products and instruments.
• Routine implant treatment is not recommended in pediatric patients with uncompleted maxillary and mandibular growth.
• Neoss implants, cover screws, abutments and abutment screws must be used solely on one patient. Single use products should not be reused due to risks of product contamination, patient/user infection and/or failure of the product to perform as intended.
• All multiple use products must be maintained in good condition and inspected before use to avoid harm to patient and damage to products. See Document 14077 (Cleaning and maintenance of Neoss Reusable Products) for inspection guidelines.
• Careful clinical and radiographic examination to assess the overall medical status of the patient before treatment. Examples of risk factors for dental implant treatment are (but not limited to):
• Insufficient bone quantity or quality
• Local or systemic infections or inflammation
• Compromised general and local health
• Poor oral hygiene
• Smoking – Alcohol or drug abuse
• Disorders, medications or therapies affecting bone and wound healing (i.e. diabetes, chemotherapy, bisphosphonates)
• History of or ongoing therapeutic radiation in the area
• Uncontrolled bleeding disorders
• Uncontrolled parafunctional habits or unfavorable jaw relationships
• Poor patient compliance
• Assess vertical and horizontal intraoral space prior to treatment to assure unobstructed use of all components and instruments.
• Biomechanical principles should be recognized when choosing loading protocol as well as for the design and construction of the abutment and prosthesis to minimize unfavorable forces. Failure to do so can lead to excessive bending force and fatigue failure of the implant or abutment components.
• When possible, modifications to prosthetic reconstructions should take place extraorally.
• Waste materials should be handled according to the established procedures for hazardous material at the hospital/clinic/laboratory.
• In the event of malfunction of the product or changes in its performance of the product, the patient should contact the dentist for assessment.

ADVERSE EFFECTS
Adverse effects related to dental implant treatment includes but are not limited to:

• Intervention related trauma
• Damage to adjacent teeth
• Fracture of the jaw bone
• Temporary or permanent nerve injury (dysesthesia or paresthesia)
• Unintended sinus membrane perforation
• Post-operative bleeding
• Hematoma
• Aspirated or swallowed products
• Allergic reaction
• Malpositioned implant
• Postoperative discomfort/swelling/pain
• Bone necrosis
• Infections
• Inflammatory reactions
• Pain
• Implant loss/failure/fracture
• Prosthetic product failure/fracture
• Excessive bone loss
• Excessive gingival pressure/tension
• Peri-implantitis
• Phonetic difficulties
• Esthetic problems

MAGNETIC RESONANCE IMAGING (MRI)

Neoss dental implants and implantable restorative products have not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating, migration, or image artifact in the MR environment. The safety of these products in the MR environment is unknown. Scanning a patient who has these products may result in patient injury.
FOR THE USA ONLY
Caution: Federal (USA) law restricts the sale of this product to or on the order of a licensed physician or dentist.
ADDITIONAL INFORMATION
Serious incidents: If any serious incident occurs in relation to the product, the user and/or patient should report to the manufacturer (https://www.neoss.com) and the competent authority of the state in which the user and/or patient is established.
Safe disposal of the product: Handling of hazardous material according to established procedures at the hospital/clinic.
The disposal of the product shall be performed in an environmentally sustainable manner according to local regulations. If the product is contaminated with human blood, tissue resides or other human secretions the product shall be disposed in appropriate containers for this.

SYMBOLS USED ON PACKAGING

| Non-sterile
---|---
| Keep dry
| Use by/Expiry date
| Do not re-use (single use only)
| Sterilized using ethylene oxide
| Unique device identifie
| Lot/Batch number
| Sterilized using irradiation
**| Date of manufacture
| Manufacturer
| Medical device
| Catalogue number
| Consult Instructions For Use
| Do not use if package is damaged
| Keep away from sunlight
| Narrow Platform
| Standard Platform
Rx only| CAUTION:** Federal (USA) law restricts the sale of this device to or on the order of a licensed physician or dentist
| Single sterile barrier system
| Single sterile barrier system with protective packaging outside
| Single sterile barrier system with protective packaging inside
| Notified body symbol and Neoss certificate number
| CE mark and notified body numbe

Neoss AB
Arvid Wallgrens backe 20
413 46 Göteborg, Sweden
T +46 (0)31 88 12 80
W www.neoss.com

15347_0 2023-01 © Neoss Limited, 2023. Copyrights, design rights and trademarks in this document are Neoss documents, software and designs, if it
is not stated to the contrary. These may not be reprinted, copied, or published in whole or in part, without the written authorisation of Neoss Limited.

References

• Neoss - Intelligent Simplicity
• Neoss - Intelligent Simplicity
• Neoss - Intelligent Simplicity

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