neoss Permanent and Provisional Abutments and Prosthetic Accessories Instruction Manual
- June 9, 2024
- neoss
Table of Contents
INSTRUCTIONS FOR USE
Permanent and Provisional Abutments and prosthetic accessories
Products (Product Categories):
Impressions: Conventional Impression coping (1) · Equator Impression
coping (2) · ScanPeg (3) · TiBase ScanPost (4)
Temporary abutments: Esthetic Tissue Former (Provisional Abutment) (5)
·Provisional Titanium Abutment (6)
Final abutments: Abutment Blanks (7) · Access Abutments (8) · CoCr
Abutments (9) · Gold Abutments (10) · NeoBase Abutments (11) · Neoss TiBase
Abutments (12) · Overdenture Ball Abutments (13) · Overdenture Equator
Abutments (14) · Prepable Titanium Abutments (15) · Prepable Zirconia
Abutments (16) · Titanium NeoLink Abutments (17) Abutment/prosthetic screw:
Abutment/Prosthetic screw iGO (18) · Abutment/Prosthetic Screw Neo (19)
Burnable abutment ·
Burnable coping : Burnout Abutment (20) · Burnout Coping (21)
Laboratory : Laboratory screw iGO (22) · Laboratory screw Neo (23) ·
Replica (24)
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 Neoss Implant System Clinical Handbook (10501)
and translated versions.
Permanent and provisional abutments and prosthetic accessories are designed
for prosthetic restorations and impression taking on Neoss dental implants and
abutments. These abutments and prosthetic accessories are available in a
variety of shapes, sizes and materials to fit individual patient needs and
different production techniques.
For a specific product description, article number and dimensions please
consult the product label and the Neoss Product Catalogue.
INTENDED USE
Neoss abutments are provisionally or permanently connected to Neossimplants or
Access Abutments and used as the base onto which a fixed(non-removable)
prosthetic restoration is fitted for patient rehabilitation.They also support
and shape the soft tissue healing.
Abutment screws are used to fixate the abutment to the implant.Prosthetic
screws are used to fixate a fixed prosthetic restoration to theAccess
abutment.
Neoss Overdenture Abutments are intended as support for a removablepermanent
denture, existing or new. Overdenture attachments areembedded into the denture
to keep denture in place.
The purpose of an impression is to accurately transfer the position of
theimplant or the abutment, in relation to the patient specific
anatomicalsituation to a model for accurate manufacturing of the prosthesis.
TheScanPeg is a scan body for intraoral scanning momentarily fitted in
thescrew access hole of the Esthetic Healing Abutment to enable
digitalacquisition of the implant position in relation to the adjacent teeth
andsoft tissue.
Non-clinical Laboratory and Burnout products are used in the dentallaboratory
to manufacture prosthetics that fit correctly onto Neossimplants or Access
abutments.
Abutments and Impression products (except for TiBase Impression) areintended
for single use for a single patient.
Laboratory screws and replicas are intended for single use.
INDICATION FOR USE
Abutments and prosthetic accessories are used in conjunction with Neoss dental implants. 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.
For all abutments, patients treated with Neoss dental implants.
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.
The fabrication of the restoration is performed in a dental laboratory setting
by a licensed dental technician.
Seating of abutments and restorations in the patient’s mouth take place in a
dental office or in an environment of a comparable clinical standard by a
licensed dental practitioner or physician.
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
Permanent abutments, permanent abutment/prosthetic screws: 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.
Provisional Abutments and Provisional Abutment/Prosthetic 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. Overdenture
Attachments: With repeated snapping in and out of the denture prosthesis, the
Overdenture attachments eventually wear out over time, resulting in diminished
snap retention and perceived looseness
of the overdenture. When this happens, they are to be replaced with new
attachments.
Non-implantable Single use products: Expected lifetime is one treatment
in one patient.
For non-clinical single use products the expected lifetime is to work as
intended to prepare one prosthetic restoration.
Reusable products : Can be reused as long as the integrity and
performance of the products are maintained. The products must be inspected
before each use for visible signs of damage, deformation, wear or corrosion.
Products showing any signs of visible damage or loss of functional
compatibility (for example fit of instrument in mating part) shall be
discarded. Generally refer to instruction 14077 for assessment.
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.
- Treatment is contraindicated where the patient has a pre-existing allergy to products used for the treatment.
The Access abutments and multi abutments are contraindicated for single
implant prosthetic cases. Angulation correction of the prosthesis compared to
the implant axis of more than 30° using a NeoBase or 20° using a TiBase,
should be avoided. Single implant restorations whose length exceeds a ratio of
1:1.25 in comparison to the length of the implant, should be avoided for
eoBase and TiBase.
Neoss Overdenture Abutments and attachments are contraindicated for single
implant prosthetic cases and on implants with a greater divergence than 28°
(50° with Housing for extended divergence) in conjunction with Equator
abutments and 10° with Ball abutments.
MATERIAL
Permanent abutments are made of commercially pure titanium grade 4, titanium
alloy (Ti6Al4V), Gold or Zirconia. Equator Abutments have a titanium nitride
(TiN) coating.
Healing abutments are made of PEEK (Polyetheretherketone).
Abutment screws are made of titanium alloy (Ti6Al4V) with a pure gold
deposition.
Provisional abutments are made of titanium grade 4 or PMMA (Esthetic Tissue
Formers).
Provisional screws are made of titanium alloy (Ti6Al4V).
Impression copings and posts are made of stainless steel or commercially pure
titanium grade 4 if blue colour coded for NP components. ScanPegs and Burnout
products are made of PMMA.
Replicas are made in stainless steel.
STERILITY AT DELIVERY
Most abutments, screws, prosthetic accessories and non-clinical products are
typically not provided sterile.
Products that are supplied sterile, such as Access abutments, are marked
sterile on the packaging with a given expiry date. Sterile abutments are
irradiated using Gamma.
DAMAGED PACKAGING
If the packaging of a non-sterile product is damaged make sure to inspect the
product visually and ensure that the product itself isn’t damaged.
If the packaging of a sterile product is damaged upon delivery the product
must be disposed.
PREPARATIONS BEFORE USE
Preparation before use is required for Provisional abutments, Prepable
abutments, Gold abutments, CoCr abutments and Abutment blanks according to
Neoss Implant System Clinical Handbook (10501). Sterile products, products for
impression taking, replicas, screws or overdenture abutments and attachments
shall not be adjusted before
clinical use.
CLEANING, DISINFECTION AND STERILISATION
All prosthetic and reusable products for invasive use including accessories
delivered non-sterile must be unpacked, cleaned and if required sterilized
before use as per instructions in 14077. This also applies for products that
have been delivered sterile but adjusted or processed before clinical
application.
The fabricator (dental technician) and the restoration must inform the dentist
of the need to sterilize the abutment before clinical application (for US
only).
STORAGE
Unused products must be stored in their original packaging. Sterilized bags
and unused products must be stored in dry environment at room temperature and
out of direct sunlight.
PROCEDURE
For detailed information on procedures for a specific Neoss ProActive Implant
System product, please consult Neoss Implant System Clinical Handbook (10501)
which also includes information on procedures related to the dental
laboratory.
Impression : The clinician either takes a conventional impression using
an impression material with the impression coping attached to the implant or
abutment, or a digital impression using a compatible digital impression coping
such as ScanPeg or TiBase coping as per the Neoss Implant System Clinical
Handbook (10501).
The attachment of the impression coping is made by hand tightening or ‘push’
in depending on the design.
Models: Based on the impression, the dental technician creates a model,
physical or digital, with incorporated replicas representing the implants or
abutments used for the impression.
Preparation before clinical placement : The following abutments or
copings are adjusted for the clinical situation or incorporated into a
restoration according to Neoss Implant System Clinical Handbook (10501) prior
to or in conjunction with the clinical placement using a replica and provided
laboratory screw to facilitate the attachment to a model during adjustment:
CoCr Abutments · Gold Abutments · NeoBase Abutments · Neoss TiBase Abutments ·
Prepable Titanium Abutments · Prepable Zirconia Abutments · Titanium NeoLink
Abutments · Provisional Abutment Tissue Former · Provisional Titanium Abutment
· Burnout Abutment · Burnout Coping · Abutment Blanks
Depending on workflow, different design and production techniques are used
including digital design tools and milling options referenced in Neoss Implant
System Clinical Handbook (10501).
Products attached to the replica are hand-tightened using the lab screw.
Design and preparation work is conducted by a dental technician, or for
certain solutions chair side by a clinician, following product specific design
limitations such as post height, post angulation, marginal height, wall
thickness, material processing and cementation. Provisional restorations used
during the healing phase, should be designed out of occlusion. Make sure to
protect the implant connection on the abutment during blasting, polishing or
other procedures that can damage the connection. Surfaces exposed to the oral
cavity or soft tissue are recommended to be smooth. Copings or crowns,
temporary or permanent, are made following standard procedures according to
the material manufacturer’s instructions. The restoration is forwarded to the
clinician together with the abutment screw or provisional screw, packaged to
avoid any damages during transportation.
Placement of abutment or restoration: Non-sterile delivered dental
restorations including abutments and copings should be cleaned, disinfected
and when required sterilized as per the “Cleaning and disinfection” and
“Sterilization” sections above prior to being clinically used.
Confirm that the appropriate Neoss abutment screw is used (applicable for all
abutments except Overdenture abutments where the screw is incorporated into
the abutment). The Neo screwdriver is used for all abutments except for
abutments with angulated screw channels (NeoBase ASC and Abutment blanks ASC)
where instead the iGO screwdriver is required.
After the removal of the cover screw, healing abutment or provisional
restoration from the implant, clean and dry the implant connection. Position
the abutment or single tooth restoration in the implant while making sure that
the retentive elements of the implant/abutment connection are properly aligned
before the screw is tightened. Tighten the abutment screw using the
screwdriver in combination with the Neoss Ratchet set at the required torque
listed below and on the packaging of the abutment or the screw. Note that
Access angulated abutments requires a Neo screwdriver of 22 mm or longer.
Screw and Screwdriver compatibility
Neo Screws and Neo Screwdriver
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.
The implant to the abutment connection is essential to the mechanical
stability of the dental implant system. The abutment connection is not to be
modified.
Any change to this abutment connection will characterize your facility as a
medical device manufacturer subject to FDA registration, fees, regulation and
restrictions (for US only).
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 is performed 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 identifier
| 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 number ·
Neoss AB
Arvid Wallgrens backe 20
413 46 Göteborg, Sweden
T +46 (0)31 88 12 80
W www.neoss.com
15348_1 2023-03 © 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
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