Anthogyr A02 Ball Abutment Instructions
- June 14, 2024
- Anthogyr
Table of Contents
Anthogyr A02 Ball Abutment
Description
Medical device abutment type consisting of an attachment part (Novaloc® or ball Ø2.25 mm compatible with Dalbo®) and a connection part compatible with the Axiom® im-plants (BL or TL). Anthogyr produces a full range of products for secondary parts, ancillaries, and accessories compatible with Novaloc®/Dalbo® PLUS.
Indications:
These abutments are indicated for the stabilization of the complete or partial
removable prostheses on Axiom® BL or Axiom® TL dental implants.
Contraindications
Implant divergence superior to 40° between two implants.
Allergy or hypersensitivity to chemical components in materials used :
- Novaloc® abutments: titanium alloy (Ti-6Al-4V ELI), DLC coating (a-C : H).
- Dalbo® abutments : titanium alloy (Ti-6Al-4V ELI).
Warnings and Precautions
The safety and compatibility of abutments in a magnetic resonance environment
have not been evaluated. Reactions to overheat-ing or migration in a magnetic
resonance environment have not been tested.
Only clinicians with thorough training in dental implants should install these
parts.
The instructions found in the Axiom® user guides must be followed carefully.
This docu-ment is available at ifu.anthogyr.com or upon request from Anthogyr
at the address above.
Prosthetic parts must be attached to avoid inhaling them or swallowing them
during intraoral use.
Failing to follow the procedures described in the user guide instructions may lead to one or more of the following complications :
- Damage to the implant, prosthetic part orother parts
- Loosening of the implant, prosthetic partor other parts
- Improper final restoration
- Mastication problems for the patient
- Implant rejection
- Implant removal
Any serious incident occurring in conjunction with the device must result in the notifi-cation of the manufacturer and the compe-tent authority of the Member state in whichthe user and/or patient is based
Single-use devices
The abutments are single-use devices. They must not be reused (risk of contamination and risk of altering the functional surfaces). Anthogyr cannot guarantee the operability or safety of a product if it has been reused. Anthogyr is not responsible for parts that are re-sterilized by the user.
Cleaning and sterilization
These abutments are supplied NON-STER-ILES. They must be cleaned and sterilized according to the cleaning and sterilization manual available on the ifu.anthogyr.com website (search code : AXDA015 for exam-ple) or simply upon request from the An-thogyr website mentioned above
Protocol
ABUTMENT PLACEMENT
-
Select abutments with an appropriate height according to the implants and attachments desired.
-
Tighten the abutments to 25 N.cm using the appropriate mandrel (INMHECV forNovaloc® abutments / INMOICO for Dalbo® abutments) and using an INCCD dynamo-metric or Torq Control® instrument.
Tightening at a torque higher than the recommended one may break the abutment and/or the implant. -
Confirm the perfect connection between the implant and the abutment by a retro-alveolar X-ray.
PREPARATION OF THE PROSTHESIS
The prosthesis must be prepared according to prosthetic techniques for
removable restorations on implants.
Any abnormal use of the abutment may result in its fracture.
In addition to the present IFU, user guide instructions for the Novaloc®/Dalbo® attachment systems are available from the manufacturers :
- Cendres+Métaux SA : www.cmsa.ch
- Valoc AG : www.valoc.ch
PATIENT INFORMATION, MAINTENANCE
Maintenance by the clinician: examine the state of each abutment during
periodic visits. The base of the prosthesis on the soft tissue must be checked
at least once a year, failing that, the prosthesis must be relined to avoid
abnormal use of the implant assembly.
Maintenance by the patient :
(please forward the following information to the patients) : Patients must
accept regular medical follow-ups and should consult their doctor in case of
any unexpected change in the performance of the prosthetic reconstitution. The
patient must be made aware that regular buccal hygiene is essential and that
the abutments must be carefully cleaned every day.
Safety, responsibility
This product should be used only with An-thor components and instruments. The
user is completely responsible for the proper use and handling of this
product. Each component is labeled with a catalog reference and a batch
number: the user must ensure the traceability of the components used for each
patient.
The facility performing the insertion is responsible for handling waste
resulting from the procedure (packaging, extracted components, etc.) as
medical waste.
Anthogyr disclaims responsibility in the event of clinical failure related to
not following the surgical protocol.
Anthogyr thanks you for your trust and is available to provide you with any
additional information
- Medical device complying with European Directive 93/42/EEC.
- Attention: The accompanying instructions must be consulted; Danger.
- See the precautions for use.
- Do not reuse.
- Not sterile.
- Sterilization by autoclave without packaging, at the specified temperature.
- Catalog reference.
- Batch number.
- Do not use if the package is damaged.
- Manufacturer.
- Manufacturing date.
- Federal (U.S.) law restricts this device to sale by or on the order of an authorised dentist.
- Complies with norms and standards in Russia.
- GTIN : Global Trade Item Number
Anthogyr 2 237, Av. André Lasquin 74700 Sallanches
France Phone : +33(0)4 50 58 02 37
Fax : +33(0)4 50 93 78 60
www.anthogyr.com
Email : contact@anthogyr.com
Edition: A02 REF. 063PASP_NOT_EN Ball abutment (Dalbo®) and Novaloc® on
Axiom®