Anthogyr 0459 Constituent Material Of The Tita Instructions (+ PDF)

0459 Constituent Material of the Tita
Instruction Manual

0459	Medical device complying with European Directive 93/42/EEC.
	Attention: The accompanying instructions must be consulted; Danger.
	Do not reuse.
	Not sterile.
	sterilization by autoclave without packaging, at the specified temperature
	Catalog reference.
	Batch number.
	Do not use if the packaging is damaged.
	Manufacturer.
	Date of manufacture
	Federal (U.S.) law restricts this device to sale by or on the order of an authorized dentist.
	Complies with norms and standards in Russia.
	Tightening torque
GTIN	Global Trade Item Number

Contents hide

1 Description

2 Indications

3 Sterilization

4 Instructions for use

5 Documents / Resources

5.1 References

6 Related Posts

Description

Titanium base for customized prosthetic restoration on Anthogyr Axiom® REG/PX implants.
M1.6 Black OPTS160 screw to firmly secure the customized prosthetic restoration to the implant.

Indications

Single-tooth cemented restorations and single-tooth restorations that are screw-retained on Anthogyr® Axiom REG/PX implants.

Contraindications
Allergy to a constituent material of the titanium ases: Ti6Al4V-ELI titanium.

Warnings and Precautions
Only clinicians trained in dental implants should install these components.
Single-use devices: do not reuse or resterilize.
Risk of contamination and risk of deterioration of functional surfaces.
Prosthetic components must be attached to prevent accidental inhalation or swallowing during intraoral use.
The titanium bases should not be modified (neither on the gingival nor on the coronal section).
EVERY MODIFICATION RISKS WEA KEN IN G TH E ME CH AN ICA L STRENGTH OF THE COMPONENT. Only sanding of the coronal section is permitted using corundum (Al2O3) with a particle size of 50 μm to 125 µm and at a pressure of 2 to 4 bars IN CASES WHERE SANDING IS REQUIRED BY THE MANUFACTURER OF THE CEMENTATION MATERIAL.
The M1.6 Black OPTS160 screw may only be used in order to firmly secure the prosthetic restoration to the implant in the mouth.
If the procedures described in these instructions for use are not followed, one or more of the following complications may result:

Damage to the implant, the prosthetic component, or other components
Loosening of the prosthetic component or other components
Incorrect final restoration
Impairment of patient mastication
Rejection of the implant

Sterilization

The titanium base provided together with its final screw is supplied non-sterile and should be cleaned and sterilized in accordance with the procedures in place for working with dental prostheses prior to placement inside the patient’s mouth.
CONSULT THE RECOMMENDATIONS OF THE MANUFACTURERS OF THE RESTORATION MATERIALS (COPING AND CEMENT) REGARDING COMPATIBILITY WITH THE METHODS OF STERILISATION.

Instructions for use

Fabricate the suprastructure using CAD/CAM machining or using the press technique. CONSULT THE RECOMMENDATIONS OF THE MANUFACTURERS OF THE RESTORATION MATERIALS REGARDING THE MINIMUM THICKNESS OF THE SUPRASTRUCTURE. WHERE ZIRCONIA IS MACHINED, THE THICKNESS OF THE ALLS OF THE SUPRASTRUCTURE SHOULD BE GREATER THAN OR EQUAL TO 0.4 mm. Where the suprastructure is fabricated by machining, the corresponding CAD library can be downloaded at www.anthogyr.com.
Assemble the titanium base with the suprastructure in order to create the prosthetic restoration. CONSULT THE RECOMMENDATIONS OF THE MANUFACTURERS OF THE CEMENTATION MATERIALS REGARDING THE CEMENTATION PROTOCOL. In order to cement the ZIRCONIA superstructure, Anthogyr recommends the use of the following cement: MULTILINK AUTOMIX from IVOCLAR VIVADENT or PANAVIA F2.0 from KURARAY DENTAL.
Clean and sterilize the prosthetic restoration as well as the M1.6 Black OPTS160 screw.
Screw the prosthetic restoration onto the implant using the M1.6 Black OPTS160 crew with 25 N.cm, for example with the aid of an INCCD or TORQ CONTROL® dynamometrical instrument.

Safety, Responsability
The proper use and handling of this product are entirely the responsibility of the user; they are performed without any supervision on our part.

Patient information
The patient should agree to regular medical follow-up and should consult his/her doctor in the event of an unexpected change in the performance of the prosthetic reconstruction.
The patient’s attention should be drawn to the necessity of regular oral hygiene. Anthogyr thanks you for your trust and is available to provide you with any additional information.

0459
Anthogyr
74700 Sallanches – France
Phone : +33(0)4 50 58 02 37
Fax : +33(0)4 50 93 78 60
www.anthogyr.com
Email : [email protected]
Edition : 2020-06
REF. 063EMBASE_NOT_EN