Production process

Design

All the Oxy Implant products are designed internally by our Research and Development Division. This is possible thanks to the presence of different and complementary professionals, able to examine the specific aspects that should be considered at this stage: choice of the materials to be used, product industrialisation, compliance with the relevant regulations, the sustainability of the project. All this takes place by the inspiration and under the direct supervision of the two Founders, which, at this stage, can provide the fundamental contribution resulting from their ultra thirty year experience in this specific field combined with the desire and capacity to listen to the expertise of so many Oxy Implant customers.

For an even more overall assessment of the new products, the company has also historical relations of collaboration with external experts: Doctors of historical and proven know-how capable to evaluate the usefulness and reliability of the clinical concept, Engineers specialised in analysis with FEM software for prior identification of weaknesses, departments and university laboratories capable of performing mechanical tests on prototypes to confirm their reliability.

Production

Regarding the raw materials used for the production of all the devices, Oxy Implant® relies only on highest level suppliers, for example the special titanium of Swiss origin used for all the dental implants manufacturing is commercially pure grade 4 and thanks to a special process of cold-drawing, its resistance was increased to more than 40%. The drawn bar is subsequently rectified with linearity and narrow dimensional tolerance that allows to reach during machining a very high degree of accuracy.

The latest generation machines used by Biomec to produce internally 100% of the OXY Implant components are equipped with the best numerical control technology that allows to work with tolerances of a few microns. This is the resource that allows to build a precise implant-abutment connection with a tolerance between 0 and 20 microns, a factor among the most relevant for the success of the implant treatment.

People are however the essential element, in fact in the production department work specialised and continually trained young technicians, who thanks to their enthusiasm and their momentum allow to confront and overcome even the most difficult technical challenges.

Quality System

🇬🇧 Biomec srl is the manufacturer of the Oxy Implant implant system and is directly involved in the design, production and marketing of all its devices at its headquarters in Colico (LC) – Italy, adopting a certified Quality Management System since 1998 in accordance with the international standards ISO 9001 (“Quality management systems – Requirements”) and ISO 13485 (“Medical devices – Quality management systems – Requirements for regulatory purposes”), constantly updating it.

Biomec srl has been involved in the development and production of components for implantology since 1990 and created and proposed the Oxy Implant system to the market in 2005, obtaining the CE marking, initially according to Directive 93/42/EEC and from December 2022 according to the EU Regulation 2017/745.

The Oxy Implant implant system, including implants, prosthetic components, surgical instruments and accessories, has been assessed by the Notified Body IMQ (0051) and deemed compliant with the new stringent European standards, confirming the quality of the processes adopted for its construction and security and performance of all devices.

The Manufacturer repeatedly carries out checks on the production process of the Oxy Implant implant system to ensure that the quality of the products is always constant over time and is subjected to an annual inspection visit by the Notified Body.

Biomec commits to provide the doctor who uses the Oxy Implant implant system with safe, high-performance and innovative devices to be able to take better care of their patients.

Control

The control process of Oxy Implant products in terms of compliance with the dimensional requirements fixed on the technical drawings is divided in two phases:

– first there is a spot-check which takes place in the production department and is carried out on newly manufactured semi-finished products. At the end of each machining hour, the last piece produced is brought in metrology room and analysed in its essential characteristics that are tested with the appropriate plug gauges “Go/Not go” and with digital optical instruments which allow to measure up to a tenth of a micron; if at the end of this check all the tests have given a positive result, the workpiece is considered compliant as well as all the output per hour. In the case of a negative result all the articles produced in that hour are instead collected and verified one by one

– a second and final check takes place in finishing and control departments where specialised technicians repeat the procedures described above for each single component produced.

All checks are recorded in a special management software and reviewed quarterly by the Quality Manager who makes a critical analysis and a possible corrective action in collaboration with the Department Managers and the Directorate.

Total control for a total quality.

Surface treatment

AMS (Advanced Micro Surface) is the surface selected for the OXY Implant system entire range of implants. It is realised through a combination of processes of etching, decontamination and treatment with Argon plasma at cold that generates a homogeneous microporosity with the distance between the peaks of a few microns. This characteristic, together with the high level of cleanliness of the surface, is decisive to stimulate the biological response of osteoblastic cell adhesion and consequently encourage the osteogenesis process. The advantages are evident: an excellent bone-to-implant anchorage, a greater torque value for implant removal and, in conclusion, a greater percentage of clinical successes. The treatment process that generates the AMS surface is performed by a specialised Italian company of proven experience.

All the treated implants are controlled with an optical microscope to assess compliance, some samples for each batch are analysed with a scanning electronic microscope to verify compliance with the required characteristics. A surface treatment and cleanliness validation are carried out every six months before and after the final packaging in the cleanroom with subsequent emission of a report, controlled in phase of annual inspection by the notified body.

Package System

The outer package of the implants is made of cardboard and has a convenient tear-off opening system.

Its graphics provide indications regarding the type of connection and the name of the implant line. External stickers show colour coding and all the specific data of the implant: description, reference number, production batch, expiry date and manufacturer.

Inside the package there is a tube containing the implant and the cover screw, their sterility obtained by irradiation with Beta rays is guaranteed for 5 years. There are as well the instructions for use and 3 stickers with description, reference and batch number of the implant to be applied respectively on the medical record, on the patient’s implant passport and on any additional documentation.

The prosthetic components and surgical instruments that are not present in the surgical box are packaged in thermosealed polyethylene bags provided with a sticker showing all the device data, they are supplied non-sterile and must be sterilised before use.