Quality control, control of quality

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03
Quality

03

CONTROL OF QUALITY
OR QUALITY CONTROL?
Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution.

Control of quality or quality control? A play on words, useful in explaining that checking is not enough for IML.
Control in IML is synonymous with uncompromising elimination of all those components that present the slightest imperfection even if only aesthetic.
It means making a commitment to selling only very specific components in order to be “as precise as the Swiss”. 
THE QUALITY CONTROL PROCESS

MEN, MATERIALS
AND MACHINES

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 and radioactivity
• Mechanical production using latest generation sliding head machines

SL SURFACE TREATMENT

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.


DECONTAMINATION

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 aluminium, universally considered possible causes of implants failing to osteointegrate;
• Procedure: liquid solution treatment;

Phase 2
• Objective: organic contamination removal, such as removal of pro-inflammatory agents;
• Procedure: treatment using gas cleaning agents applied via an electro-chemical process performed in the plasma reactor.

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.
Copies of certificates are available on demand.
IML SA products are medical devices marked:

FDA 510 (k) approved

IML SA’s Quality Management for the design, manufacture, and marketing of dental implants,  Instrumentation, and related accessories complies with the Directives and regulations in force.

EC (Class I) and EC 0425 (Class IIb and Class IIa)

Manufactured in accordance with Medical Devices Directive 93/42/EEC and subsequent modification, amendments, and supplements.

[ICIM]

UNI-EN ISO 9001:2015

UNI CEI EN ISO 13485:2012

UNI CEI EN ISO 13485:2012
PACKAGING



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.
The methacrylate vial with Polyethylene (PE) top is carefully washed and dried.
The transparent Polyethylene Terephthalate (PET) container is closed with a white Polypropylene (PP) stopper with a safety seal.

The cardboard box (3.5 x 6,2 x 3,5 cm) must be stored in a dry place at room temperature.
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