Anthogyr A02 Ball Abutment Instructions

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®

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