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About DenPlus

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PROFILE


For more than 25 years, DenPlus has been designing, manufacturing and distributing dental products. Initially, DenPlus specialized in the field of removable prosthesis and orthodontics. Among its flagship products, DenPlus has developed acrylics for dental bases with unique characteristics in terms of fast curing and mechanical properties. Among the star products, High-Wave acrylic for microwaves can be cured in 3 minutes or Impact-20 resin, which requires only 20 minutes to cure in boiling water. Various laboratory products have been developed over the years such as Separa-Plus separator liquid or NetPlus cleaners.

In addition to dental acrylics, DenPlus has gradually added products with unique features for you and your customers. For example, the Enigmalife tooth offers unmatched aesthetics and excellent wear resistance. Diaswiss burs represent a variety of products well suited to denturists and dental laboratories. Several unique products are constantly being added to our product line.

Recently, DenPlus has moved to digitalization by offering affordable solutions for new digital technologies. 3D scanners and printers are now available and we make sure to test and validate these products so that we can offer you fast and reliable technical support.

DenPlus, a 100% Canadian company, sells its products directly across Canada and the United States. To maintain high quality standards, DenPlus holds ISO 13485: 2016 and MDSAP certifications. Our dental acrylics are also registered with 510 (k) at the Food and Drug Administration (FDA). Maintaining these certifications requires DenPlus to have a quality management system for all aspects of its manufacturing and marketing process.


All the companies preach quality and customer services. However, it is difficult to achieve these goals if a system of management of quality were not set up in the company. Since 2003, DenPlus is certified ISO 13485.



What is ISO?


ISO (International Organization for Standardization) is the world’s largest developer of standards. Although ISO’s principal activity is the development of technical standards, ISO standards also have important economic and social repercussions. ISO standards make a positive difference, not just to engineers and manufacturers for whom they solve basic problems in production and distribution, but to society as a whole.

ISO is a network of the national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization: its members are not, as is the case in the United Nations system, delegations of national governments.

Because "International Organization for Standardization" would have different abbreviations in different languages ("IOS" in English, "OIN" in French for Organisation internationale de normalisation), it was decided at the outset to use a word derived from the Greek isos, meaning "equal". Therefore, whatever the country, whatever the language, the short form of the organization’s name is always ISO.

In canada, international standards are revised and modified by the Canadian Standard Association (CSA). Afterward, they are approved by the Standards Council of Canada (SCC) to become a national standard.


What is Management Quality System?


Management system refers to the organization’s structure for managing its processes - or activities - that transform inputs of resources into a product or service which meet the organization’s objectives, such as satisfying the customer’s quality requirements, complying to regulations, or meeting environmental objectives.

Since 2000, ISO 9001 standard is oriented toward a process aproach instead of a product oriented approach. The obejctive is to increase the customer satisfaction by meeting customer requirement.

Several aspects are covered by the management quality system. Among most important, the following points must be covered:

      • Management and control of documentation and records
      • Quality policy and management responsibility
      • Customer satisfaction
      • Design and development
      • Risk Management
      • Purchasing and verification
      • Preparation of the product, labeling and traceability
      • Control of processes
      • Non-conformity
      • Recall procedure


Difference between ISO 9001 and ISO 13485


The ISO 13485 standard is a version directed towards the medical instruments and the safety of the users and it is much more demanding than the ISO 9001 standard. For example, ISO 9001 requires 6 documented procedures whereas ISO 13485 requires 34 documented procedures.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.



ISO 13485 and Health Canada 

In Canada, manufacturers of medical devices must comply with the MDSAP criteria which are based on the international standard ISO 13485: 2016. The MDSAP (Medical Device Single Audit Program) is a quality management system that allows several international regulations to be grouped together and to be audited only once. Currently, five countries are part of the MDSAP: Canada, the United States, Japan, Brazil and Australia. It therefore includes all the requirements of ISO 13485 plus the requirements specific to each regulation.

A distributor does not have this obligation to comply with the MDSAP. DenPlus being a manufacturer and a distributor, it is the only fully Canadian dental distributor certified MDSAP and ISO 13485: 2016 in Canada. DenPlus’ MDSAP certification covers Canada and the United States.

Quality Policy of DenPlus

The quality policy of DenPlus is founded on the following elements:

  • To give our customers in dentistry products and services that satisfies their needs
  • To manufacture quality and innovative dental products
  • To maintain the effectiveness of the management quality system in order to meet the requirements of our customers and of the regulation organizations
  • To give resources to our employees to fulfill the requirements of the management quality system

 

DenPlus is ensured to maintain the system effectiveness of quality for the medical instruments of class II but it can improve those, like those of class I, if the regulation requirements are respected. This policy quality is communicated and understood within the company. It is re-viewed annually with each management review.



Certifications


 DenPlus is certified ISO 13485 : 2016 and MDSAP. BSI, an organization recognized by Heath Canada,  is the registar of Denplus.



Audits of our Management Quality System

 

DenPlus is audited twice a year! 

Annually, an internal audit (verification) is carried out by an external consultant and a formal and obligatory audit is done by the registrar (BSI.) to certify that the procedures of quality management are strictly respected.

If major nonconformities in the quality system are found, DenPlus can lose its certification. These verifications ensure you an optimum level of satisfaction.

 

Which is impact for you and your customers?

The peace of mind! ISO 13485 ensures the continual control of all the stages of production, from design to manufacture and distribution. The system of quality set up is reflected on all the processes of the company and thus enable you to have very high level of comfort compared with the products you provide to patients



The philosophy of DenPlus always was to invest significantly in R&D activities  to develop innovating products for the dental market and to add an important value to its products.

Since its foundation, DenPlus developed several innovating products for denturist and dental laboratories. For example, the chemistry of some of our dental acrylic resins were modified to allow very fast curing, either in boiling water or in microwave oven, and this without any problem of porosity. These products are unique on the market.

Initially, DenPlus selected primarily its R&D projects according to the dental market demand by selecting projects at reduced risks. The first projects were based on the weak performance of the competing products or on the possibility that we had to appreciably reduce the costs of manufacturation. Currently, DenPlus tries to increase the innovating level of these products to accentuate the demarcation of the company compared to competition.

Since 2003, DenPlus put in place a stronger structure of project management in conformity with the standard ISO 13485 for management of the quality system applicable to the medical devices. This structure ensures that the products are developed by holding account of the regulations of the markets targeted by ensuring the safety of the products.