I would like to introduce you all to the department I work in at Ultradent, Regulatory Affairs. We have a group of five folks that works diligently to support Ultradent’s enormous product line.

Here’s our group:

Pictured left to right are Ruth Gardner, Marie Hess, Diane Rogers, Corey Jaseph, and Karen Kakunes. Diane and Corey are managers, Ruth and Marie support international registration efforts, and Karen prepares technical files and supports the whitening line.

One of the main regulatory duties is to work with project teams during the design phase before a new product is brought to market. There are a number of international standards specifying product design and performance, called ISO standards (for International Standards Organization), and RA ensures that our products are tested to and meet these standards. Regulatory people also help the project team to assign a risk classification to each device, based on what kind of adverse effect the device can have on patients and users of the product. Of course, the risk classification systems are different in every country – e.g., Canada is different from the US, and both are different from the EU (European Union) and Japan. Because of this, people in regulatory have to have a grounding in many different countries’ laws.

Another important regulatory duty is to prepare product submissions for the US and EU so that we can sell our products legally. In the US, this is a submission called a 510(k) and this document is sent to the Food and Drug Administration (FDA), who reviews and then ‘clears’ the product. It takes a number of months to prepare the submission and it takes 30 – 90 days to hear back from the FDA. For the EU, a technical file must be prepared, specified by the European Medical Device Directive (an EU law). The technical file is reviewed by a consultant called a Notified Body, someone who has been approved by the EU governing body to audit to its laws. Both the technical file and the 510(k) take time and effort to prepare and are the result of working with many teams throughout the company.

Regulatory’s other main duty is to provide documentation to distributors and consultants so that UPI products can be registered in over 100 countries throughout the world. Every country has different requirements and needs. Many countries have not translated their laws into English, so distributors and consultants within that country prepare the submissions. Our team supports these efforts by providing information about our products to these countries. These activities must be done when a product is first registered in a country, and many countries also have periodic re-registration requirements, so our team is kept busy around the clock and year round.

These are the three main activities in Regulatory Affairs. We do a lot more than this, but these are our first and highest priorities, ensuring that our products are and continue to be legally registered in the markets that we sell them in.

It is so exciting to see how Ultradent’s mission to “improve oral health globally” really does stretch to all areas of the globe. I am so appreciative of the opportunities Ultradent has given me to experience interactions with wonderful, caring and sharing people around the world.

In January and February I was in South Africa for 2 ½ weeks. While there, I had the opportunity to visit two universities and talk with approximately 75 fifth year students and 30 hygienists. I was in six different regions and had numerous meetings with about 200 dentists, mostly in small groups of 15 – 25. We had some excellent interaction with some very kind and interested dentists.

I just returned from the Ukraine and Azerbaijan in March; it is always nice to hear the sincere and loving thoughts our distributors have for our founder, Dr. Dan Fischer. Our distributor in Azerbaijan was proud to show me that his screensaver features a picture of himself with Dr. Fischer taken in Italy during a past conference. While I visited there, I was able to spend about six hours training the sales reps and on the second day, we had two discussion groups with dentists for about 3 ½ hours each. Our distributor from Azerbaijan will also be coming to Utah in April with a group of 18 dentists for our Russian Key Educators Conference.

Anytime I travel for these training sessions, I make everyone place the Treswhite in their mouths while I talk about our whitening product line. I have been having them leave it in their mouths for about 1 to 1 ½ hours! Out of the 12 salespeople, 10 had some whitening results during their first use -- FANTASTIC results! I made them commit to me that they all would continue to whiten only their upper arches for the next five or so days and then not whiten their lower arches for at least one year. They were ecstatic! In fact, during the break, one of the salespeople was down in their dental depot showing a dentist the difference between upper and lower arches -- after only 1 hour of treatment! You could see the excitement on his face. Many of the dentists had similar results.

In these tough economic times, I have been encouraging the salespeople to highlight the Treswhite to their dentist customers as an inexpensive alternative to custom trays. This allows patients an affordable option with some profit for the dentist, whereas otherwise the patients may walk away due to costs.

I will again leave this Sunday for a crazy trip to Romania, Bulgaria, Macedonia, Croatia, Serbia and Zagreb. The main topics I want to share with the salespeople are:

• Product benefits in view of economy
• - Tips on how to communicate the benefits of buying premium products as opposed to cheap competitors
• - Demonstration techniques to help new customers feel comfortable trying our products