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A significant milestone in implant production quality management

The presentation of the certificate to Carsten Cieslik (left), general manager of Komet Custom Made, and Klaus Rübesamen (right), CEO of Brasseler, by Dr Dirk Duddeck of the CleanImplant Foundation. (Image: CleanImplant Foundation)
CleanImplant Foundation

CleanImplant Foundation

Tue. 5. April 2022


BERLIN, Germany: The CleanImplant Foundation, an established authority in evaluating the quality and cleanliness of implant surfaces, has awarded its Certified Production Quality seal of excellence to Komet Custom Made, a German supplier and original design manufacturer of ceramic implants.

According to Dr Dirk U. Duddeck, managing director and head of research at the CleanImplant Foundation, scanning electron microscope (SEM) analyses of more than 100 different commercially available implant systems found that more than half demonstrated significant impurities.

“These contaminants on new, sterile-packaged implants, which are entirely preventable on the manufacturer’s side, unfortunately have clinical consequences and harm both practitioners and patients,” Dr Duddeck stated. “It is our responsibility to inform dentists accordingly and provide a stage for quality manufacturers,” he continued.

Quality assured by rigorous testing

Based on the established CleanImplant consensus guideline on the cleanliness of dental implants, the Certified Production Quality seal is only awarded by the independent non-profit organisation after an extensive testing process conducted in an accredited testing laboratory. This certification is awarded to contract manufacturers such as Komet Custom Made that produce high-quality implants for various trade labels.

“The certification by the CleanImplant Foundation for ceramic implants confirms the process reliability of the quality assurance measures in place at the company, including validated final cleaning and subsequent packaging in the clean room, and represents a further milestone in ensuring the overall ceramic competence of Komet Custom Made,” noted Carsten Cieslik, general manager of Komet Custom Made.

As part of the family-run company Brasseler, Komet Custom Made offers a range of services, including implant design expertise based on many years of experience, the sophisticated packaging and manufacturing of ceramic implants, and the provision of other material and equipment, including abutments and implantology drills.

A beneficial mark for implant suppliers

Suppliers of implants produced by companies carrying the Certified Production Quality seal can benefit from this marker in multiple ways. The initiation of testing to obtain the coveted Trusted Quality Mark is facilitated by the CleanImplant Foundation. Conceptualised as an orientation tool for dental professionals, this mark may be awarded only after SEM analysis of five randomly selected samples of the same type and a final peer review of all results.

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