Our special concern – quality assurance
Many practitioners rely on quality, but are unsure how the product qualities of, for example, alloys can be reliably assessed. However, in the sensitive field of dental technology, in particular, such criteria are a valuable aid for achieving exclusively high-quality results. From the point of view of the specialist, it is the following factors, in particular, that are decisive when it comes to the class and value retention of a material:
- Manufacturer’s expertise
- Development in compliance with standards
- Biological compatibility
- Controlled quality
- Certified QM systems
As a company with almost 100 years of experience in the development and production of dental products, we only measure ourselves against the highest benchmarks in all of these criteria.
The manufacturer’s expertise
Can expertise be precisely defined? Yes, we think so. For example, by taking responsibility for our own products, with future-proof developments, safety standards and controlled quality, as well as through the level of local technical support. We are happy to be assessed on this performance, which we recommit to on a daily basis. Use these benefits to your advantage!
Development in compliance with standards
Only top-class products should be used for sensitive areas such as the mouth and teeth. In dental alloys, in particular, priorities therefore focus on optimal biocompatibility and adherence to current standards. All our dental alloys are developed and tested to be in compliance with the following standards:
DIN EN ISO 9693 Dental restorative metal-ceramic systems
DIN EN ISO 22674 Dentistry – metallic materials for fixed and removable restorations and appliances
DIN EN ISO 9333 Dentistry – brazing materials
Biological compatibility is not a matter of course. It must be guaranteed by appropriate manufacturing methods, as well as by extensive and regular inspections. We have our dental alloys regularly inspected in close cooperation with independent testing institutes. The following testing methods are employed:
- Cytotoxicity testing: growth inhibition test in compliance with ISO 10993-5
- Sensitisation testing: test for irritation and sensitisation in compliance with ISO 10993-10
- Corrosion testing: static immersion test in compliance with ISO/CD 10271
- Metal ion determination in DMEM eluate
The results even satisfied our own especially high quality demands. The results of the corrosion tests show that metal ion discharge is below the limit value recommended in standards. The cytotoxicity test revealed no cytotoxic potential. Skin irritation or allergic sensitisation could not be determined. In short, Heimerle + Meule dental alloys are absolutely biocompatible.
Trust is good; control – even of your own performance – is better. We analyse the chemical composition and purity of each batch of molten alloy. Together with the documented results, this complex procedure guarantees uniform quality of the highest standard.
During testing, we leave no stone unturned. Spectroscopic analysis methods are employed (ICP = inductively coupled plasma, AAS = atomic absorption spectroscopy); in addition, thermal and strength properties, and microstructure are extensively investigated. Confusion is absolutely impossible: the LOT number printed on each package guarantees traceability.
Certified QM systems
Dental alloys must comply with numerous regulations. In principle, they are subject to the requirements of the Medical Products Act (MPG) and European Medical Device Directive 93/42/EEC. With their high standard of quality and proven biocompatibility, our dental alloys meet these stringent specifications – with no caveats.
The CE mark – prescribed for medical products within the European Union since 1998 – adorns all dental alloys produced by us. We pay particular attention to our quality management system for developing, manufacturing and selling dental alloys, all certified in compliance with EN ISO 13485 for medical products. Together with the whole group’s quality management system certified according to EN ISO 9001, it reinforces the enormous trust that our customers rightly invest in our products.