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Control, for IML means making a commitment to put on sale only perfect components, in full respect of the commonplace that reads "as precise as a Swiss".
It means taking on the costs that this commitment entails, which IML pursues and proudly maintains, in full respect of its ethics, the health of the patients and the professionalism of the surgeon.|
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Only the
best raw materials, the most advanced technology, and the best professional.
These
secrets of IML guarantee excellent products, free from manufacturing defects.
•
Super-skilled operators able to develop a man-machine relationship able to
optimise the features of their tools to achieve maximum performance
• Top
quality titanium for medical use. grade 4 for implants and grade 5 for
prostheses. IML titanium is exclusively imported from the United States, is
guaranteed free from manufacturing defects, mercury and radioactivity
•
Mechanical production using latest generation sliding head machines
The IML Research and Development team, in partnership with prestigious chemistry laboratories which specialise in implantology, has formulated the optimum surface treatment for their implants: the SL treatment. The performance monitoring has been entrusted to the Polytechnic of Turin and to the University of Turin, which also periodically check production lots.
IML SL treatment is technically comparable to the best SLA® treatments, the most documented in the literature. The resulting surface has an appropriate structure for anchoring osteoblasts and promotes good integration of the implant with the bone tissue. In fact, this type of treatment suits any type of bone thanks
to its ability to increase primary stability even in the presence of atrophic sites or compromised biological tissue.Even the
decontamination process used for IML implants was developed in collaboration
with the Research and Development team of the Polytechnic University of Turin
and the Department of Surgical Sciences at the University of Turin’s CIR
Dental School. This is a two-stage process, the second stage being composed of
passing the implants through a plasma reactor.
Phase 1
•
Objective: inorganic waste removal, mechanical machining, and surface
treatments leave residues such as carbon and aluminum, universally considered
possible causes of implants failing to osseointegrate;
•
Procedure: liquid solution treatment;
Phase 2
•
Objective: organic contamination removal, such as removal of
pro-inflammatory agents;
CERTIFICATIONS
Quality
Maintenance is IML’s guiding principle in a lifetime project embodied in the
IML Production Protocol, a constantly evolving tool applied to the daily
production of each component.
IML SA
products are marked Medical Devices.
FDA 510 (k) approved
EC (Class I) and EC 0425 (Class IIb and Class IIa)
[ICIM]
UNI CEI EN ISO 13485:2012
IML’s packaging process is performed in compliance with the standards set by the EC 93/42 Directive, which guarantee the sterilization shelf-life. The IML implants are sterilized by beta rays.
The implants are packaged in a vial that, in turn, is placed inside a plastic container safety seal cap. Then the plastic container is placed inside a cardboard box bearing a removable label, bearing the implant information details.
Further two copies of the label are into the cardboard box, to be placed on the implant passport and on the patient’s medical record sheet.
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