Anthogyr OPFLEX413 BL FlexiBase Global Distributor Owner’s Manual

Anthogyr OPFLEX413 BL FlexiBase Global Distributor

• Medical device compliant with European Directive 93/42/CEE
• Warning: you must read the accompanying instructions; Danger
• Do not reuse
• Non-sterile
• Sterilize without packaging in an autoclave at the indicated temperature.
• Catalogue reference
• Lot code
• Do not use if the packaging is damaged
• Manufacturer
• Date of manufacture
• United States Federal law restricts this
• device to sale by or on the order of authorized dentists.

Description

• The FlexiBase® mentioned in the table be-low are used for personalized prosthetic restorations on Axiom® TL, Axiom® BL implants and Multi-Unit abutments.
• The permanent prosthetic screw is delivered with Lexicase®.
• For the Axiom® BL range, Lexicase® components are removable.

Indications

Single-unit and multiple-unit screw-retained restorations on Axiom® TL, Axiom® BL implants and Multi-Unit abutments.

Contraindications

Allergy to Titanium Ti6Al4V-ELI.
The FlexiBase® on Multi-Unit abutments must not be used if there is an axis gap wider than 40° between 2 abutment analogues, as inserting the prosthesis may turn out to be impossible.

Warnings and precautions

• Only clinicians trained in dental implants should install these components.
• Single-use devices: do not reuse or resterilise . Risk of contamination and risk of deterioration of functional surfaces.
• Prosthetic components must be attached to prevent their accidental inhalation or swallowing during intraoral use.

Flexi Base® must not be altered

• E (neither on the gingival nor on the crown area); risk of mechanical weakening.
• Only the sanding of the crown portion is tolerated with corundum (Al2O3) with 50 μm to 125 µm granulometry and under a pressure of 2 to 4 bars.
• The screws OPTS160, MU140, TS160 and TS160P must only be used to secure the prosthetic restoration on the implant in the mouth.
• Failing to follow the procedures described in these instructions may lead to one or more of the following complications
• Damage to the implant, prosthetic part, or other components
• Loosening of the prosthetic part or other components
• Improper final restoration
• Malfunction of the patient’s chewing
• Implant rejection.

Cleaning and sterilization

• Please refer to the recommendations of the manufacturers of restoration materials (superstructure and adhesive) on the  compatibility with means of sterilization.
• All components and instruments are sup-plied NON-STERILE. They must be cleaned and sterilized according to the cleaning and sterilization manual available on the web-site ifu.anthogyr.com (search code: OPFLEX413, for example) or upon request from Anthony at the address above.

Please refer to the recommendations

• by CAD-CAM machining: the related CAD library can be downloaded from the www.anthogyr.com website
• Please refer to the recommendations E of the manufacturers of restoration materials on the minimum thickness of the superstructure in the event of zirconia manufacturing.
• by molded technique: use of the associated cartable cap (see table below).

Before applying the adhesive, screw the Lexicase® on the analogue with the short laboratory screw (Ref. OPTS161 for Axiom® BL, Ref.

• TS163 for Axiom® TL, Ref. MU141-4 for Multi-Unit) or long
• (Ref. OPTS162 for Axiom® BL, Ref. TS162 for Axiom® TL, Ref
• MUT101 and Ref MUT102 for Multi-Unit).

Glue the superstructure on the Lexicase®.
Please refer to the recommendations of the manufacturers of adhesive materials on the gluing protocol. For gluing a ZIRCONIA supra-structure,

Anthony recommends the following adhesives
PANAVIA TM (F2.0 / V5 / Cement Plus) from KURARAY DENTAL or MULTILINK AUTOMIX from IVOCLAR VIVADENT.
lean and sterilize the prosthetic restoration

• Clean and sterilize the prosthetic resto-ration and the permanent prosthetic screw.
• Screw the prosthetic restoration on the implant / abutment using its own permanent prosthetic screw using an INCCD or TORQ CONTROL® torque wrench. The Flex-base® must be tightened to the recommended torques indicated in the table be-low.
• Close the access channel with filling material after protecting the screw head.

Safety and responsibility

Correct use and manipulation of this product are carried out outside our control, and they are the user’s responsibility. Anthony shall not be held responsible for clinical failure due to not following the protocol explained above.

Patient information

• Patients must accept regular medical follow-up and should consult their doctor in case of an unexpected change in the performance of the prosthetic reconstitution. Patients must be informed of the need to ensure regular oral hygiene.
• Anthony thanks you for your trust and will be happy to supply you with additional information.

INSTRUCTIONS FOR USE

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