English - Instruction For Use (English); Use Environment - Elos Accurate Hybrid Base Gebrauchsanleitung

English – Instruction for use (English)
Elos Accurate® Hybrid Base™
1. Intended purpose
The Elos Accurate® Hybrid Base™ is intended for dental prosthetic
restorations. The Elos Accurate® Hybrid Base™ is used as an interface
between an endosseuos dental implant and a dental restoration and will be
attached to the implant using a prosthetic screw and attached to the dental
restoration by cementing.
Elos Accurate® Hybrid Base™ Engaging are applicable for single tooth
restorations.
Elos Accurate® Hybrid Base™ Non-engaging are applicable for used for
multiple tooth restorations.
2. Product description
The product consists of the Elos Accurate® Hybrid Base™ which is
manufactured from biocompatible titanium alloy (TiAl
The product is available for a variety of implant platforms and sizes. For
specific product descriptions, please refer to individual product labels.
3. Chemical composition
Chemical composition of materials used for the Elos Accurate® Hybrid
Base™ is presented in table 1.
Table 1: Chemical composition of Elos Accurate Hybrid Base made of
anodized titanium alloy
Material Composition
Anodized Titanium 33.3 at.% Ti + 66.6
alloy (Color oxidized) at.% O (TiO
Titanium alloy 90 wt.% Ti, 6 wt.%
(Ti-6Al-4V-ELI) Al and 4 wt.% V
4. Basic UDI:
Elos Accurate® Hybrid Base™ Engaging: 5712821007001VC
Elos Accurate® Hybrid Base™ Non-engaging: 5712821011001UD
5. Indication for use
The Elos Accurate® Hybrid Base™ is indicated for patients with edentulism,
who need single or multiple dental restorations attached to a dental implant.
6. Intended patient population
The Elos Accurate® Hybrid Base™ is intended to be used in patients that
are considered eligible for dental implant treatment. No special training of
the patient is required.
7. Intended users
For the preparation of the dental restoration the Elos Accurate® Hybrid
Base™ should only be handled by dental technicians who are experienced
within prosthetics for dental implantology.
For the installation of the dental restoration in patients the Elos Accurate®
Hybrid Base™ should only be used by dentists who are experienced within
dental implantology.
7.1.

Use environment

Dental labs need to have 3D milling equipment suitable for milling of
customized dental restorations.
8. Clinical benefits
The Elos Accurate® Hybrid Base™ can successfully be used to establish a
prosthetic restoration to treat patients with edentulism.
9. Expected lifetime
Expected lifetime of up to 25 years, corresponding to the state of the art as
assessed in the clinical evaluation.
Elos Medtech Pinol A/S
Engvej 33
DK - 3330 Gørløse
www.elosmedtech.com
Document ID: DEV-01274 version 14.0 released 2023/03/03
V ELI).
6 4
Patient
CAS nr.
contacting
Yes (Outer layer) 1317-80-2
)
2
No (Inner layer) 99906-66-8
10. Contraindications
•
The Elos Accurate® Hybrid Base™ Non-Engaging is not intended for
implants having a divergence angle more than 30° relatively to each
other besides the following Elos Accurate® Hybrid Base™ Non-
Engaging which have a implants divergence angle below 30°. (Ref.
No. HBN-HET35H-1 ≤ 22°, HBN-HET45H-1 ≤ 22°, HBN-NGM45H-1 ≤
16°)
•
The Elos Accurate® Hybrid Base™ Engaging is not intended for
ceramic restorations angled more than 20° relative to the implant.
11. Warnings and precautions
•
The Elos Accurate® Hybrid Base™ components must never be
changed or modified.
•
The component included in the product is for single-use only.
•
Reuse of the component can result in loss of functionality and/ or
infections.
•
The Elos Accurate® Hybrid Base™ must be attached to the implant
or abutment using an Elos Prosthetic Screw or Elos Accurate®
Hexalobular Prosthetic Screw.
•
Tightening and loosening of the Prosthetic screw must be done by
use of an appropriate screwdriver. Elos Accurate® Hexalobular
Prosthetic Screws must be used with an Elos Accurate® Prosthetic
Screwdriver 18mm, 26mm or 34mm (Ref. No. PS-AH18-1, PS-AH26-
1 or PS-AH34-1).
•
When mounting the Prosthetic Screw, it is important to use a manual
screwdriver before using any kind of torque wrench.
•
Since the Elos Accurate® Hybrid Base™ and Prosthetic Screw are
small they must be handled with caution to avoid the patient from
swallowing or inhaling them.
•
Place implant-borne restorations only in occlusion when the implant is
completely osseointegrated.
•
Always place temporary restorations out of occlusion.
•
Allergies to the titanium alloy grade 5 ELI (TiAl
the alloy may very rarely occur.
•
The Elos Accurate® Hybrid Base™ components must only be used
and handled by dental professionals.
•
The use of torque value higher or lower than the recommended for
the implant system according to the manufacturer's instruction may
result in damage to the Elos Accurate® Hybrid Base™, the Prosthetic
screw and/or the implant
•
Elos Accurate® Hybrid Base™ Non-Engaging is not intended for
single tooth dental restorations.
•
When intra oral cementation is intended, make sure that insertion
direction of the restoration allows it.
12. Compatibility information
The Hybrid Base is available for a variety of implant platforms and sizes.
The individual product label refers to which implant platform and size the
product is compatible with.
The Elos Accurate® Hybrid Base™ variants for Multi-unit (HBN-MUA45-1;
HBN-MUA45H-1) are compatible with following abutment platforms:
•
Nobel Biocare® Multi-unit NP/RP
•
Astra Tech™ Multibase EV
•
Neodent® GM Mini Abutment
•
BioHorizons Multi-unit abutment
•
Biomet 3i™ Low Profile Abutment
13. Cleaning and Sterilization
The Elos Accurate® Hybrid Base™ prosthetic components are delivered
non-sterile. Prior to attachment of the dental restoration in the patient's
mouth, it must be cleaned followed by sterilization. Further instruction can
be found in "Cleaning and sterilization guideline" at:
https//elosmedtech.com/IFU/
Clean according to the guidance in the "Cleaning and sterilization
1.
guideline".
V ELI) or contents of
6 4
3