The Euronda Monoart saliva ejector

The safety of a saliva ejector starts with the materials. For this reason, the Euronda Monoart saliva ejector is a Medical Device made of non-toxic, transparent PVC. 

It is free from phthalates, which are substances used in some plastics to increase their flexibility and which are now the focus of particular attention under European regulations on chemical substances, such as the REACH Regulation, and in assessments of CMR substances (carcinogenic, mutagenic or reprotoxic). This decision underscores Euronda’s commitment to patient and operator safety, through the use of materials selected and tested according to the intended use of the device. 

In line with our commitment to ensuring high safety standards, the PVC used is biocompatible in accordance with ISO 10993. This means that the material has been assessed as being well tolerated by the body under the intended conditions of use, even in the event of contact with the oral mucosa. It also complies with the requirements of EU Regulation 10/2011 for materials intended to come into contact with food, confirming the care taken in the selection and inspection of raw materials. 

When a product is intended for daily use in the dental practice, the quality of the material is not a secondary detail. The selection of raw materials, the inspection of components, and attention to compliance all impact the safety of the device, its reliability, and the peace of mind of those who use it every day in close contact with patients.

The Euronda Monoart saliva ejector is designed to guarantee comfort even during longer treatment procedures or for particularly sensitive patients, without compromising the ease of use for the operator.  

Every detail that comes into contact with the patient’s mouth can make a difference. That’s why the rounded cap, which is available as fixed or removable depending on the model, is designed to be gentle on the mucous membranes. Its shape helps to reduce the feeling of discomfort during use and makes the device more suitable even for sensitive or irritated mucous membranes. 

But comfort is not just about the cap. It also depends on the ability of the saliva ejector to remain in the desired position, without requiring continuous adjustments during treatment. 

This feature allows the device to be positioned in a stable and functional way, promoting smooth suction and helping to keep the surgical field drier and more accessible. At the same time, the design of the saliva ejector helps to reduce the risk of kinks or blockages that could interfere with continuous suction, thereby preventing the accumulation of saliva and fluids in the oral cavity. This helps the patient feel at ease during the treatment and allows the operator to work more smoothly and safely. 

A comfortable, reliable, and effective saliva ejector allows the patient to have a better experience of the treatment and allows the operator to work more smoothly, without having to continuously reposition the device or interrupt the procedure.

Even a seemingly simple device requires a careful and controlled process. That is why product quality begins during the manufacturing process, even before it is used in the practice.

Euronda Monoart saliva ejectors are in fact produced using automated, hands-free processes, which eliminate direct handling by operators. This aspect is particularly important because, although they are not sterile, saliva ejectors are intended for use in the patient’s oral cavity. For this reason, it is essential that production takes place according to defined procedures, in environments with adequate hygiene and quality standards, contributing to the microbiological safety of the product.

To ensure an additional level of control, Euronda carries out periodic tests on samples of saliva ejectors, using an accredited laboratory to monitor the bioburden, i.e. the quantity of micro-organisms present on the device.

The quality of the saliva ejectors is also constantly checked throughout the production process, through automated checks on each individual piece produced, and through manual destructive spot checks, to ensure that the device meets the required standards and offers consistent performance over time.

On the production lines, there are three automatic checks integrated into the production machinery: one check using a sensor, and two using cameras. These systems check that the length of the saliva ejector, that it folds correctly, and that the cap is inserted correctly.

There is also an automatic check designed to count the pieces inside each bag to ensure correct packaging. In the case of welded saliva ejectors, an additional automatic check also verifies that the cap is correctly attached to the saliva ejector.

In addition to the automatic checks, operators also carry out periodic manual checks on the finished product. The checks include:

• visual inspection to ensure the absence of discolouration or deformations;
• checking the diameter of the cannula (6.5 mm);
• checking the cap sealing;
• checking the bonding of the copper-clad wire;
• checking the length of the tube (excluding the cap);
• checking the pouch seal;
• checking the weight of the pouch;
• checking that the code, batch, and label correspond.

To ensure greater objectivity, operators also carry out cross-checks , taking turns conducting quality control during production.

In addition to these checks, there are daily checks carried out by the Quality department, which randomly analyzes a sample of at least 10 bags of saliva ejectors for each batch. The checks include verification of the cap seal using a dynamometer, which performs a tensile test to measure the strength of the cap. The viscosity of the PVC is also checked using a plastometer, an instrument that simulates the behaviour of the material during the extrusion of the saliva ejector.

This combination of automated checks and frequent random checks ensures continuity of production, compliance, and product reliability, transforming an everyday device into a safe choice that has been tested in accordance with Euronda standards.

When it comes to disposable devices, sustainability primarily involves three aspects: the raw materials, the manufacturing process, and the packaging.  

The raw material used is phthalate-free PVC. This choice contributes to patient safety and, at the same time, reflects a real focus on sustainability, limiting the use of additives that are also considered problematic due to their possible impact on the environment. 

During the production of saliva ejectors, the water used to cool the material is 100% recycled and reused, helping to limit the consumption of resources during the production process. The quality of the process water is also monitored through monthly analyses carried out by an external laboratory, which checks compliance with the required parameters. 

In terms of energy, Euronda makes choices aimed at reducing the impact of the production process. Since 2020, the company has been using energy from renewable sources by selecting a supplier specializing in the production of green energy. In addition to this, there is the contribution of the company’s recently upgraded photovoltaic system, which enables the self-generation of energy up to a maximum nominal power of 700 kWp. 

Production waste is also managed with a view to recovery and reuse. Every year, around 31.5 tonnes of waste from the production of saliva ejectors are entrusted to a specialist company, which processes it to separate the metal wire from the plastic components. The recovered plastic is then reintroduced into a new production chain, where it can be repurposed and transformed into new products. In this way, Euronda reduces waste, repurposes materials that would otherwise be destined for disposal, and helps to reduce the environmental impact of the production process. 

Finally, our packaging has also been carefully designed: our saliva ejectors are packaged in recyclable plastic bags and cardboard sourced from FSC-certified forests, which means managed in accordance with strict environmental, social and economic standards, to protect biodiversity and the balance of forest ecosystems. These are practical choices that reduce environmental impact without compromising product safety and quality. 

In a sector where disposables play a fundamental role in hygiene and the prevention of cross-contamination, an important aspect of corporate responsibility is focussing on materials, energy, manufacturing processes, waste recovery, and packaging. 

The Euronda Monoart saliva ejector is a Made in Italy product. This means the processes are directly monitored and strict quality control is maintained at every stage: from the selection of raw materials to the actual production, from quality control to packaging. 

Manufacturing in Italy also means operating in full compliance with European regulations, which are among the strictest in the world in terms of safety, quality control, and traceability of Medical Devices. For Euronda, Made in Italy is not just about geography. It represents a way of designing and manufacturing products with constant attention to materials, processes, compliance, and the safety of patients and operators. 

The Euronda Monoart saliva ejector is a Medical Device that complies with the European MDR EU 2017/745, which regulates Medical Devices placed on the market in the European Union. This legislation has introduced stricter requirements in terms of safety, technical documentation, post-market surveillance, traceability, and transparency throughout the entire medical supply chain. 

For dental practices, choosing MDR-compliant devices means being able to rely on products that are inspected, traceable, and compliant with European standards. This is an important aspect not only from a regulatory point of view, but also in the day-to-day operations of the dental practice, where every device that comes into contact with the patient must offer clear and verifiable guarantees. 

Saliva ejectors are often considered basic accessories, and for this very reason there is a risk of them being taken for granted. Yet, there is much more to a quality saliva ejector than meets the eye. 

There are certain aspects that the operator immediately notices during use: the ability to maintain its position, consistent suction, gentle contact with the patient, and practicality in daily work. And there are aspects that are less tangible, but equally important: the choice of materials, the absence of phthalates, the energy used during production, the automatic and manual inspections, and the quality checks performed throughout the production process. 

It is precisely the combination of these elements, visible and invisible, that defines the value of the Euronda Monoart saliva ejector. A flexible, safe and versatile product, available in different colours and variants, designed to adapt to the needs of the dental practice and simplify the work of those who use it every day. 

Choosing a saliva ejector Made by Euronda means choosing much more than just a small disposable product. It means choosing manufacturing expertise, process control, quality materials, and a genuine focus on the daily work of the practice. Because, in dentistry, every detail contributes to making treatment safer, more efficient, and more comfortable.