Instructions for Use

Contraindications

• Allergic reaction to titanium Ti6Al4V-ELI.
• FlexiBase® restorations for use with Multi-Unit abutments must not be used if the axis deviation between 2 abutment teeth exceeds 40°. There is a risk that the prosthesis may not be insertable.

Warnings and Precautions

• These devices may only be placed by dental practitioners with training in dental implantology.
• These prosthetic devices must be secured to prevent inhalation or swallowing during intraoral use.
• FlexiBase® must not be modified (neither in the gingival part nor in the coronal part); there is a risk of mechanical weakening.
• Only sandblasting of the crown with corundum (Al2O3) with a particle size of 50 µm to 125 µm and under a pressure of 2 to 4 bar is possible.
• Screws OPTS160, MU140, TS160, and TS160P are used only for fixing the prosthetic restoration to the implant intraorally.
• Failure to follow the procedures described in this instruction manual may cause one or more of the following complications:
  • Damage to the implant, prosthetic component, or other parts.
  • Loosening of the prosthetic component or other parts.
  • Incorrect final restoration.
  • Functional chewing disorder in the patient.
  • Implant rejection.

Cleaning and Sterilization

• Regarding compatibility with sterilization agents, follow the recommendations of the restoration material manufacturers (abutment and adhesive).
• Components are supplied NON-STERILE. They must be cleaned and sterilized according to the cleaning and sterilization instructions found on the website www.ifu.anthogyr.com (search code: e.g., OPFLEX413) or simply request from Anthogyr at the links above.

Instructions for Use

Abutment Fabrication

• By machining using CAD-CAM: the associated CAD library can be downloaded from the website www.anthogyr.com.
• For the minimum abutment thickness in the case of zirconia machining, follow the recommendations of the restoration material manufacturer.
• By casting technique: use of the associated burnout pattern (see table below).

Bonding Procedure

• Before bonding, screw the FlexiBase® onto the abutment tooth using short laboratory screws (ref. OPTS160 with Axiom® BL, ref. TS160 with Axiom® TL, ref. MUAA142-4 with Multi-Unit) or long ones (ref. OPTS161 with Axiom® BL, ref. TS162 with Axiom® TL, ref MUT101 MUT102 with Multi-Unit).
• Bond the abutment to the FlexiBase®.
• For the bonding procedure, follow the adhesive manufacturer's recommendations.
• For bonding ZIRCONIA abutments, Anthogyr recommends using adhesives: PANAVIATM (F2.0/V5/Cement Plus) from KURARAY DENTAL or MULTILINK AUTOMIX from IVOCLAR VIVADENT.

Final Assembly

• Clean and sterilize the prosthetic restoration and the final prosthetic screw.
• Screw the prosthetic restoration to the implant/permanent abutment connection with the prosthetic screw using a torque instrument INCCD or TORQ CONTROL®. The FlexiBase® restoration must be tightened to the recommended torque specified in the table below.
• Once the screw head access is protected, close the access cavity with filling material.

Safety and Liability

• Proper use and handling of this product, carried out without our control, is the sole responsibility of the user.
• Anthogyr disclaims any responsibility in case of clinical failure associated with non-compliance with the procedure described above.

Patient Information

• The patient must accept regular medical check-ups and, in case of unexpected changes in the performance of the prosthetic reconstruction, must contact their doctor. The patient's attention should be focused on the need for regular oral hygiene.

Technical Specifications

The following table details the FlexiBase® components, their associated prosthetic screws, and burnout patterns.