All within the law: Regulatory requirements.

The fulfilment of regulatory provisions in medical technology is not only a requirement, but also a real challenge for anyone who is not deeply involved in the subject on a daily basis. Meeting the necessary regulatory requirements, which are becoming increasingly complex every year, requires specific expertise and a great deal of work.

After decades of experience as a renowned distributor of rotary dental instruments, we have acquired comprehensive expertise in this sector and are therefore perfectly positioned to meet the requirements of original design manufacturers. Whenever you need to present documents, records, certificates or answers, we’ll be there to provide them for you.

The machine with which it all starts. Our head.

We are engineers, strategists, material experts, project managers, programmers, sales and logistics specialists, market observers and much more. Together, we are a team dedicated to making your dreams come true.

It doesn’t matter whether you want to improve a product or have it tested, or whether you want us to develop, implement and produce a completely new concept. We provide the complete service package.

We process or develop implants, manufacture implant drills or insertion instruments for you and we are familiar with all dental materials. We are already conducting research today into the materials, technologies and processes of tomorrow. Like this, we acquire a comprehensive knowledge of unrivalled quality. After all, we manufacture in our own production facilities. With partly self-developed turning, milling and grinding technology. And with our own ISO class 7 clean room. We can coordinate any additional services you may require with external parties, so that we remain your central contact at all times.

Whether small tasks or large projects, everything begins with the detailed definition of your wishes and ideas. And ends with the job done to perfection.

We manufacture, sort out, test and organise everything in between. We work fast while remaining flexible, and we make sure that we are always up to date from a technical and organizational aspect. The passion that has made us great always shines through. The passion for perfection and quality.

More than 90 years of insider knowledge.

Many others do this and that. We do everything. We have been in the dental industry for over 90 years and have helped to shape it. We know and master just about every aspect of the dental industry.

Among other things, our added value consists of all the experiences and measures that we can provide in order to make a product a success.

In concrete terms, we can take care of tests and provide supporting documents for your product files for you in accordance with your specifications. We find perfect logistics solutions, take on the quality management or warehouse management on your behalf and provide reliable documentation in production. We can even design and produce the packaging for you. In a nutshell, we offer you a rare and precious resource: reliability.

Our company has been family-owned since 1923, we are self-determined in our actions and in upholding our values. We always keep our promises. Even those that are not recorded in writing. For us, mutual trust is an essential, irreplaceable basis for a successful cooperation.

Successful cooperation needs its own timetable.

The moment you start working with us, your tasks become ours – no matter how small or large. We make the project ours and are not satisfied until you are.

This includes providing you with as much transparency as possible right from the start. Each phase of the realization is defined after the frontloading, i.e. the first detailed briefing. Like this, you know what to expect and when, and you are free to devote your time to other issues.

You don’t have to worry about a thing – just leave it up to us.

As mentioned, we offer you everything a product needs to be successful. Everything that relieves you of your worries and gives you the freedom to concentrate on your entrepreneurial core competencies. We put our resources at your disposal and reduce your complexity in the supply chain.

Based on your requirements, we define a project plan and provide specialists for your task who develop dental implantology products on a daily basis. We coordinate the timely development, mechanical production and packaging for you. In addition, we manage your forecasts and make sure that your products are available in the desired quantities at the desired time. Furthermore, we work with you to develop logistics concepts, reduce your procurement market risks and manage your inventories – and we do all of that with the lowest possible capital commitment.

Take, for example, the packaging: No matter how short, long, thick or thin the product is, we always work with you to find the right packaging solution so that the goods arrive safely and without problems. Whether individually packed or in batches of 100 pieces, whether sterile or non-sterile. We provide you with the corresponding validations including all simulations and common test procedures.

Take, for example, logistics: Frame or make-and-hold orders are standard for us, but we can also cater to special needs. With the help of VMI (Vendor Managed Inventory) or VMR (Vendor Managed Replenishment) solutions, we ensure that your stocks are always at an optimum level and deliver automatically when necessary. So you always as much as you need and as little as possible in stock.

Take, for example, the regulatory sector: This is complex and demands are increasing all the time. The new European Medical Devices Regulation (MDR) will come into force in 2020. We are already prepared today to manage the new requirements for you quickly and easily on a day-to-day basis.

Lemgo: implant valley?

Lemgo in East Westphalia in Germany is hardly a metropolis – quite the opposite. A traditional, quaint little town in the midst of beautiful rural surroundings.

But perhaps it is precisely this peace and quiet that we needed to become so successful. An unrivalled selection of competent experts in the fields of dentistry and human medicine are all gathered in Lemgo. Komet Dental, Komet Medical and Komet Custom Made have ensured that specialists who are recognised throughout the industry work here. You are cordially invited to visit our premises and maybe for an initial, non-binding chat. Or a binding one, of course!

Your contacts:

Carsten Cieslik

General Manager Komet Custom Made

+49 (0) 5261 701-222
ccieslik@kometcustommade.de

Andreas Annutsch

Manager Sales & Key Accounts Projects

+49 (0) 5261 701-686
aannutsch@kometcustommade.de