FAQ

 1 - Who is ProDentis?

2 - What standards does ProDentis comply with?

3 - Where can I buy ProDentis products?

4 - Can I get a paper copy of the ProDentis catalog?

5 - What is ProDentis' address?

6 - How can I contact ProDentis?

7 - About our products 

• A • What do the symbols on your article fact files and packaging mean?

• B • How should your products be cleaned, disinfected and sterilized?

• C • If a sterile single-use medical device accidentally falls during a procedure, can I resterilize it and reuse it? I use a single-use kit comprising several medical devices during a procedure. If I do not use all the medical devices in it, can I resterilize those that have not been used?

 

1 - Who is ProDentis?

• ProDentis is a company which designs and manufactures solutions for dental surgeries.

• This is principally carried out through our brands: SteriBlue, Chicago Instruments and Dental Impact.

• We are present in both France and export markets.

• SteriBlue provides consumables and single-use solutions for everyday use in the dental surgery.

• Chicago Instruments supplies hand instruments for dentists and dental technicians.

• Dental Impact - Best price for single-use


• In addition, in France we partner the following brands: Frasaco, Eve, Moyco, etc.

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2 - What standards does ProDentis comply with?

• We listen to dentists and dental technicians so that we can provide the best solutions to their needs. Our products are manufactured to very detailed specifications. We adhere to a rigorous quality policy. In addition, our specifications and products comply with the requirements of European directive 93/42 EEC relating to medical devices. Our CE 93/42 certificate is available on request.

• Sterilization of our medical and dental devices is carried out in compliance with the EN 11135-1 and 556 standards relating to sterilization.

• In accordance with the emphasis we place on quality control, our company is certified compliant with the ISO 9001 and 13485 quality management systems standards. You are welcome to consult our quality management certification.

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3 - Where can I buy ProDentis products?

• Our solutions are available through specialized resellers in the dental market.

• For a complete list of resellers, please consult our Resellers section.

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4 - Can I get a paper copy of the ProDentis catalog?

• A paper catalog is available containing all our dental surgery and dental laboratory solutions.

• You can also consult the online ProDentis catalog.

• If you would like us to send you a copy of our catalog by mail, please complete our contact form. Provide your postal address and we will mail you a copy.

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5 - What is ProDentis' address?

• Our address is:

   Port Autonome

   Bâtiment IV to VII

   9 route de la Darse

   94380 Bonneuil-sur-Marne, France


• Deliveries and collections can be made from Monday to Friday between 08:00 a.m. and 16:00 p.m.

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6 - How can I contact ProDentis?

•• By email

• To contact us by email, please complete our contact form. We will be pleased to send you our direct email addresses.

•• By telephone

• To call ProDentis, please dial +33 (0)1 55 96 15 70.


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7 - About our products 

What do the symbols on your article fact files and packaging mean?

The following table summarizes all the symbols that you will find in our documents.

parapluie Keep in a dry place
emballage-endommage Do not use if packaging is damaged
ne-pas-resterilise Do not resterilize
Non-Sterile-Noir Non-sterile product
 CE  

The product complies with the main European Directive requirements applicable to the product concerned and the appropriate compliance assessment procedures have been carried out

SingleUse "Do not reuse" means = single use, only use once
 sablierYYYY-MM  "Use before" This symbol is designed to indicate that the product should not be used after the end of the month indicated or, where appropriate, the day indicated.
 REF Catalog reference
 LOT Manufacturer's batch code
 Fabricant-date AAAA-MM Date of manufacture      
Fabricant "Manufacturer" This symbol is accompanied by the name and address of the manufacturer (the person or company making the product available on the market)
Sterile-EO Sterilization method using ethylene oxide
Attention "WARNING" This symbol is primarily a safety symbol used to highlight the fact that certain warnings or specific precautions associated with the product do not appear on the label.
 Notice "Consult the user notice"
temperature

Temperature limits (minimum and maximum)

 

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How should your products be cleaned, disinfected and sterilized?

In the interests of health and safety, to avoid any risk of contamination, devices must be cleaned, disinfected and sterilized in accordance with the following recommendations, drawn up pursuant to EN ISO 17664.

- Before first use (except for devices which are sold as sterile).       Products which are sold as sterile display the symbol STERILE and the sterilization method (EO for Ethylene Oxide) 

Sterile-EO

- When products are sold in both sterile and non-sterile states, the non-sterile product displays the following symbol 

Non-Sterile-Noir

- After each use (for reusable products). Products which may not be reused display the symbol

SingleUse 

Products which may not be resterilized display the symbol 

 ne-pas-resterilise

General recommendations

• It is essential to sterilize devices which are delivered in a non-sterile state prior to first use, in accordance with the procedures set out below.

• It is the responsibility of the user to sterilize the product prior to first use and reuse. Use of a soiled or damaged device is also at the user's sole responsibility.

• For your own safety, appropriate personal protection should always be worn (gloves, eye protection) during the preparation and use of detergent or disinfectant products.

• Do not reuse devices labeled "single use".

SingleUse 

Sterilization procedures

1.     Prior to disinfection

• If you notice dirt on the device, start by cleaning this off with a cloth.

• Clean the device carefully (particularly areas that may be difficult to access) using a soft brush; do not use a metal brush or one that is too abrasive.

• Immerse all devices in a disinfectant solution as soon as possible after use. It is preferable to use a pH neutral solution.

• Follow the instructions and concentrations as indicated by the manufacturer. Using a solution that is too concentrated or leaving the device immersed for too long can, for example, lead to corrosion of the device or cracks in the material.

• In order to avoid blood residues becoming irremovable, do not use a disinfectant solution containing aldehydes.

• Do not use phenol-based disinfectant solutions or solutions containing substances incompatible with the devices (see general recommendations).

• Renew the solution regularly and at least every 24 hours or when the solution is no longer clear.

• Rinse with plenty of tap water.

• Dispose of devices showing defects (broken or bent instruments, for example, or those with signs of corrosion, etc.).

2.  Cleaning

• Dismantle devices or place hinged instruments in the open position.

• Arrange them in a container or on an appropriate support, ensuring that they do not touch one another.

• Soak them in disinfectant solution and, where appropriate, use ultrasound.

• Follow the manufacturer's instructions and recommended product concentrations (see General recommendations).

• Rinse devices with purified water (demineralized/distilled water).

• Dry devices using previously filtered compressed air. 



 

3.     Check prior to packaging

• Check the condition of devices and dispose of those presenting defects.

• Reassemble devices where necessary and ensure they are kept in the open position.

• Dispose of misshapen (bent or twisted instruments) or damaged (broken, corroded) devices or those showing other imperfections (for example, loss of markings) which may affect resistance, reliability, identification/traceability and/or the performance of the product in general.

• If devices still appear dirty, repeat steps 1 and 2.



 

4.      Packaging

• Package devices in appropriate containers capable of withstanding a minimum temperature of 134°C/273°F.

• If "sterilization bags" are used, ensure they conform to the EN ISO 11607 standard and check the expiry date of the bags as indicated by the manufacturer.



 

5.   Sterilization



autoclave-134

Steam sterilize at 134°C/273°F for at least 18 minutes.

• The sterilizer must comply with the EN 13060 standard (small sterilizer) or EN 285 (large sterilizer).

• Follow a sterilization procedure which complies with the EN ISO 17665-1 standard.

• Carry out servicing and maintenance of the autoclave in accordance with the manufacturer's instructions.

• Use only the sterilization procedures indicated.

 

Handling and storage

• Store devices in non-oxidizable containers in a clean, dry place, out of direct sunlight.

• Your devices are precision instruments. Use them carefully.

• Take all necessary care when transporting, cleaning, maintaining, sterilizing and storing devices.

• Do not use if packaging is damaged.

emballage-endommage 

Reuse

• Only devices which do not display the     ne-pas-resterilise    logo may be reused, by following the instructions above.

• Repeated sterilization has little effect on these devices.

• End of life of a product is normally determined by wear and damage linked to use.

• After several cycles, markings may start to become worn.

• DO NOT USE a device if markings on the device are no longer readable and/or if the device is misshapen (bent or twisted instrument), damaged (broken, cracked, corroded) or shows other imperfections (for example, loss of markings) which may affect the resistance, reliability or performance of the product in general.

 

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If a sterile single-use medical device accidentally falls during a procedure, can I resterilize it and reuse it? I use a single-use kit comprising several medical devices during a procedure. If I do not use all the medical devices in it, can I resterilize those that have not been used?

A single answer = NO

The basic rule

A medical device bought in a sterile state and marked as "single use" (the symbol "2" crossed out) may not be used again, i.e. after use on a patient, it may not, under any circumstances, undergo the cycle of pre-disinfection, cleaning and disinfecting or sterilization. It should always be disposed of after use, in accordance with the procedures for disposing of hazardous waste as laid down by the care establishment concerned;

Why?

Sterilization of non-reusable medical or surgical equipment or supplies can only be carried out after careful study, in particular of the compatibility of the material, product and packaging with the chosen sterilization method, whose effectiveness should also have been proven.

The physical and organoleptic features of a medical device designed for single use may be altered in the event of resterilization. There are several different types of risk involved:

 

Risks relating to the device itself:

  • the semi-crystalline structure of the polymers presents an instability which makes them vulnerable to structural changes when undergoing preparation for reuse. Such changes may result in non-measurable alterations to the device, in particular to its physical and mechanical properties and its surface state.
  • the complex structure of certain devices influences the effectiveness of procedures for reuse, resulting in non-quantifiable risks of infection;
  • the numerous materials used in manufacturing medical devices and their varied composition mean that a universal protocol cannot be established. The risks would need to be studied carefully for each medical device, and specific protocols established and approved by the manufacturer. The need to apply a specific protocol to each type of medical device is all the more difficult because the materials used are always synthetic: base polymers and additives, whose composition also varies for a single manufacturer.

 

Risks relating to clinical use:

  • certain clinical uses expose products to very high levels of contamination which are difficult to remove from synthetic materials. This makes the result of sterilization procedures very uncertain and could subsequently expose patients to serious infection.

Risks relating to procedures for reuse:

  • the presence of traces of products used in decontamination or cleaning carries the risk that toxic products may be formed during sterilization;
  • sterilization using ethylene oxide carries the risk of exposure to this toxic gas in the event that desorption is insufficient and also of even more toxic gases being produced, etc. 

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