neoss ProActive Sinus Implant Kit Instructions

: June 3, 2024
: neoss

Table of Contents

Description
Indications
Contraindications
Procedures
Drill Depth Guide
Single Use Drills
General Precautions
Procedural Precautions
Lifetime
Storage
General packaging symbols
Documents / Resources

ProActive Sinus Implant Kit
Instructions

Description

This Instructions For Use (IFU) is specifically for Neoss ProActive® Implant ∅6.5. The flange diameter on ∅6.5 implants is 6.7 mm.
Wide implants can provide additional means of anchorage in certain challenging cases, such as extraction sites and sinus floor elevations, when compared to narrow implants.

Indications

Dental implants from Neoss are used as the means of anchorage between crowns, bridges or dentures and the surrounding bone in the upper or lower jaws. Such prostheses may range from replacement of a single tooth to an entire arch of bridgework and cement or screw retained restorations. The NeossImplants – Neoss Implant System are also intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

Contraindications

Treatment is contraindicated where the patient has a preexisting allergy to the used parts. Use of drills and instruments with other than Neoss products is contraindicated.

Procedures

This Instructions For Use (IFU) is for Neoss ProActive® Implants ∅6.5. For additional information on Neoss implants and detailed information on the other specific Neoss Implant System products you are using, please consult general Instructions For Use (10538) and Neoss Implant System Guidelines (10501). A specific X-ray Planner is available.
The surgical procedure may entail a range of procedures including minimally invasive surgery and raising a full thickness flap, exposing the bone in the proposed site. A series of increasing diameter drills are used to enlarge the osteotomy for implant placement – this may involve the use of a countersink. The positions of the implant sites are determined using a round bur, lance drill or 2.2 mm twist drill. Incremental site preparation is carried out as recommended in the chart.
Note: In presence of dense bone, additional care is taken during insertion. The thread cutting and forming design of the implant acts as a screw tap. Use reverse torquing 1/2-1 turn before continuing.
All preparation of the bone tissue is carried out under profuse irrigation with saline and using an intermittent drilling technique. This prevents overheating bone 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, 800 rpm for countersinks.

Drill Depth Guide

This guide shows an 11 mm Neoss ProActive® implant in relation to a twist drill and depth guide. Please note actual distance to drill tip is 0.8 mm longer than the reference line.

Single Use Drills

The drills are delivered sterile. Please refer to IFU Cleaning and Maintenance of Neoss Reusable Products (14077) for re-sterilisation and cleaning recommendations when required.
The drills shall be placed in sterile solution (saline) during surgery if the drills are used for more than one preparation. Ensure sterile handling during preparation and surgery.
Please note instruments that are re-sterilized may not perform as intended by the manufacturer. It is the users’ responsibility to ensure that instruments have not become damaged or worn resulting in decreased performance during cleaning, re-sterilization and handling.

General Precautions

Surgical products used to achieve and maintain osseointegration should be utilized by persons trained in this method. Such training is offered at a number of centers. Please contact the manufacturer for information. Pre- operative hard tissue or soft tissue deficits may result in a compromised esthetic outcome or unfavorable implant angulation. Pre-operative patient evaluation and close cooperation between surgeon, restorative dentist and dental laboratory technician is essential for success. Neoss implants, abutments and abutment screws must be used solely on one patient. Single use devices should not be reused due to risks of product contamination, patient/user infection and/or failure of the device to perform as intended. Neoss drills and surgical instruments are used for sole placement of Neoss implants. In the event of malfunction of the device or changes in its performance of the device, the patient should contact the dentist for assessment.
Handling of hazardous material according to established procedures at the hospital/clinic.

Procedural Precautions

Because of the small size of prosthetic components, care must be taken that they are not swallowed or aspirated by the patient.
Adverse Effects
Implant techniques have normal contraindications and risks. These are extensively documented in the dental literature. Incorrect clinical placement or loading resulting in loss of implant anchorage or loss of the prosthesis are possible events after surgery. Lack of bone quantity or quality, infections, poor patienthygiene or cooperation, and general diseases are some potential causes for loss of anchorage and function.
Sterility
All Neoss implants and related bone cutting instruments are supplied sterile with a given expiry date as indicated by the packaging. For re-sterilization please refer to IFU Cleaning and Maintenance of Neoss Reusable products (14077).

Lifetime

Implants:
The patient can, if not belonging to any groups with contraindications and if device is used as intended and for correct indications, expect the dental implant treatment to restore and maintain aesthetics and/or function for a time period comparable to natural teeth.

Storage

Sterilized bags and unused components must be stored in dry environment, at room temperature and out of direct sunlight. Unused components must be stored in their original packaging.
Caution
Federal (USA) law restricts the sale of this device to or on the order of a licensed physician or dentist.
For additional information, precautions and warnings for Neoss Implants please refer to Instructions For Use for Neoss Implant System (10538).
MRI Safety Information
This device has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of this device in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

General packaging symbols

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Wwww.neoss.com
11350_6 EN 2021-12 © Neoss Limited, 2021. 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.
11350_6 EN 2021-12