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ZivEco, synonym for Made in Italy

 

 

Every single component of the implant proves that the prosthetic is conceived, designed, developed, tested and manufactured in Italy.

The high quality standard of the products it has always been placed as a priority objective. Secondary the the ever craved equilibrium "price / quality".

The quality is so on first place. The constant verification of the production stages, sample checks, checks on individual implants and prosthetic elements ensure a continuous compliance with the quality standards always high. All the stages and processes, from production to packaging, underlying the issue of the document known as the "lotto" with accompanying documentation related, which allows traceability of products and ensure compliance with regulations in force.

ZivEco make available and freely accessible their certifications which guarantee the compliance of the production and distribution processes, under the heading "certifications".

The continuous research and testing are seeking to prevent production problems. The only raw material used is titanium for medical use, certified and of the highest quality. The use of titanium for medical use in the production of  "implant" components, ensure their maximum biocompatibility and the best process of osseointegration. Its grade 4 (surgical titanium) used for its resistance to corrosion, erosion and temperatures up to 425 ° C, is composed as follows:


Ti %

Titanium

O %

Oxygen

Fe %

Iron

N %

Nitrogen

H %

Hydrogen

C %

Carbon

99,5507

0,267

0,16

0,007

0,0013

0,014

The implant surface is chemically passive, non-magnetic. The material used complies with the standards and specifications:

ASTM B348 – 08a Standard Specification for Titanium and Titanium Alloy Bars and Billets;

UNI 9763/2 "Surgical implants. Unalloyed titanium ";

ISO 5832-2 “ Implants for surgery – Metallic materials – Part 2 : Unalloyed titanium”;

ASTM F67 – 06 “ Standard Specification for Unalloyed Titanium, for Surgical Implant Applications ( UNS R50250, UNS R50400, UNS R50550, UNS R50700)”.

The delivery of materials from the manufacturer is accompanied by certificates of chemical and mechanical analysis, for medical and surgical use.

ZivEco uses only Titanium from safe sourcing and with certificate of origin with all requirements of compliance, traceability and safety.

Surface treatment

Nano-teK: glossy neck. Micro body blasted with zirconium balls disposable of 30 and 70 microns, which ensures perfect cleaning of the system without leaving any trace of contamination; etched (nitric acid and hydrofluoric acid).

Decontamination

Decontamination processes by:

- surfactants, nitric acid (favors the formation of TiO ₂).

- argon cold plasma (plasma reactor in a clean aseptic room controlled with nitrogen).

Dry steam cleaning 8/9 bar and with water vapor in autoclave, temperature = 136 ˚ C, pressure 1-1.2 bar = (15 -17 psia) with reaction time of at least 30 minutes before packaging the product.

Sterilization

In containers with laminar flow and white room class K100.

Irradiation with ionizing rays (gamma rays 25 KGray).

Quality of the process

The entire production process is implemented and constantly controlled in accordance with the UNI EN ISO 9001:2008 and UNI CEI EN ISO 13485:2012.

CE Marking

Dental implants are covered by the CE marking (CE 0426 - see CE certificate) attesting to their compliance with established safety requirements under the Legislative Decree 46/97 and Legislative Decree 37/10 according to the European Directive 93/42 and subsequent amendments, on Medical Devices.

 


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