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minieast1On August 10th, 20 participants from 12 DTA member organizations converged in Baltimore to attend the “first” DTA Mini-Dental School East session held at the University of Maryland School of Dentistry. Created in response to popular demand for the program, the Mini-Dental School East was modeled after the “original” Mini-Dental program at the University of Colorado School of Dental Medicine that DTA Members have been attending since 2003.  The two day sessions provide insights into the knowledge and skills that dental professionals receive in dental school with an emphasis on hands-on learning experiences. 

Continuing the focus and efforts of the 2015 DTA Future Trends Forum The Dilemma and Impact of Gray Market Product Sales, the July/August issue of Apex 360 magazine features a 23 page special report titled The Dental Gray Market.  As well as succinctly defining the Dental Gray Market in its various forms and levels, it also includes input from a diverse panel of industry experts representing manufacturing, distribution, dental laboratories  and the Dental Trade Alliance.  Contributors included DTA Executive Director, Gary Price, Vice President of Marketing/Merchandise for Patterson Dental, Tim Rogin, International Vice President for 3M ESPE, (and Future Trend Forum panelist) Simon Hearne, Chief of  Staff Executive of the National Association of Dental Labs, Bennett Napier, CAE, and Vice President and Director of Education at Marotta Dental Studio Inc., Steven Pigliacelli, CDT, MDT.

The current Apex 360 article not only provides a timely reminder to the growing issue of the Dental Gray Market and its impact on both the integrity of the industry and the ultimately safety of the public, but also provide insight into steps the dental industry has and can take to combat this issue.  You can click here to read the feature’s interview with Gary Price on the DTA strategy to address the issue of Gray Market as the voice of the dental industry.  To read the entire special report, go to http://www.dentistryiq.com/apex360-newsletter.html to sign in or to subscribe to Apex 360.

exportIntroduction to Sino–Dental Meeting in Beijing

June 2015 - The China International Dental Exhibition and Scientific Conference (Sino–Dental) in Beijing (every June) is a well–attended Chinese dental meeting. The Sino–Dental Meeting is celebrating its 20th anniversary this year.  It is managed by the International Health Exchange and Cooperation Center, National Health and Family Planning Commission and the Central Government of China. The recent Sino–Dental Meeting was held at the China National Convention Center (CNCC) in northern Beijing near the 4th Ring Road and Olympic Village.

Approximately 100,000 attendees visit the Sino–Dental Meeting. This includes nearly 60,000 dentists from Beijing and other sections of mainland China, with 700 companies exhibiting in 2015 including large German, Japanese, South Korean, Swiss and Chinese pavilions.  Many of the booths in the main exhibition hall are hosted by the local distributors who are authorized to sell these German, Swiss and even US devices.

There are a large number of scientific educational programs hosted by the Sino–Dental organizers and industry. A number of meetings and events take place during the Sino–Dental Meeting and in the evening immediately following the close of the exhibition. Nearby is the Olympic Village where the Chinese Olympics were held in 2010 including the famous Aquatic Center and the Bird’s Nest where the opening ceremonies took place.

DTA Members should review the new Hazard Communication Standard Final Rule to be sure that all applicable labeling and Safety Data Sheets are fully compliant for the June 1 and December 1, 2015 deadlines.

Hazard Communication Standard Final Rule:   New changes to the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard are bringing the United States into alignment with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), further improving safety and health protections for America's workers. Building on the success of OSHA's current Hazard Communication Standard, the GHS is expected to prevent injuries and illnesses, save lives and improve trade conditions for chemical manufacturers. The Hazard Communication Standard in 1983 gave the workers the ‘right to know,' but the new Globally Harmonized System gives workers the ‘right to understand.'

 

Written by DTA Regulatory Consultant, Blix Winston.

Recently, DTA met with FDA staff who went into detail about 510(k) applications that result in refuse to accept (RTA) letters—more than 60% of all applications receive RTAs—and found out what members can do to avoid receiving a rejection.

One of the ways to avoid receiving an RTA letter is to include an annotated copy of the RTA checklist with your application, to help FDA find each required item. However, even when an applicant does this, there are still pitfalls that cause applications to be rejected. 

Written by DTA Regulatory Consultant, Blix Winston.

As you’re probably aware, 510(k) review procedures have changed.

If you receive a refuse to accept (RTA) letter, it will be accompanied by a copy of the checklist indicating the deficiencies. You have 60 days to respond and send in the needed information. After that time, your application will be deleted. If this happens, your user fee has not been used up and can be applied to the next submission. 

Written by DTA Regulatory Consultant, Blix Winston.

The FDA has issued the final version of the reprocessing guidance for 510(k) submissions and provided a help helpful guidance webinar that you can watch at www.fda.gov/training/CDRHlearn

The revised guidance contains must-have information if your 510(k) submission includes either sterile devices or devices that you intend the end user to clean and reprocess. Much of the discussion about this during a recent meeting between FDA and DTA centered on how FDA expects applicants to conduct validation of cleaning and sterilization processes. For example, FDA expects that two quantitative tests will be conducted for cleaning. Applicants should validate these tests to measure residual soil on your device, including negative and positive controls. Microbial log reductions should not be used to validate cleaning soiled devices. Soils appropriate to the environment in which the device is used should be considered.

The guidance is not retroactive but applies to submission received by FDA after Mar. 24, 2015.  Validation of cleaning and sterilization process should be treated independently in the submission.

One question at the meeting concerned cleaning agents. If your application recommends five different cleaning agents and three sterilization methods can be used, you should test all 15 combinations to validate that they work.

February is Children’s Dental Health Month!  To kick off this month, the Ad Council has released an update on the Kids' Healthy Mouths campaign that has garnered more than $78 million in donated media since its launch in 2012.  A second phase of creative materials has just been released to media outlets nationwide.  New Toothsavers mobile video game characters (Rabbit, Pinnochio and Alice In Wonderland) will be available and there is continued support from Scholastics with materials for caregivers and teachers.  “Created pro bono by Grey New York, the Kids’ Healthy Mouths PSAs stress that while most parenting is difficult to do in two minutes, such as learning how to cook or ride a bike, making sure kids brush for two minutes, twice a day is something a little simpler. The Zooppa video contest winners capture the spirit of the original PSAs and feature a lighthearted look at parenting today. The videos will be highlighted on the Kids' Healthy Mouths social pages throughout the month of February.”  PR Newswire, New York, February 10, 2015

 Campaign Website:  www.2min2x.org 

Ad Council Website:  http://adcouncil.org/Our-Campaigns/Health/Children-s-Oral-Health

Partnership Website:  www.healthymouthshealthylives.org 

The DTA Foundation raised $117,172 through the Silent Auction held during the 2014 DTA Annual Meeting.   Funds raised from the auction support the Foundation’s Grants and Scholarship programs.  As an example of what your donations can do, $100,000 allows the Foundation to fund 4 grants or up to 20 scholarships!  This is the first year that all proceeds from the auction went directly to the Foundation.  It was also the first year to utilize mobile bidding. DTA members quickly mastered this new format and participated in a fun evening of raising awareness for increased access to oral health in America.

A wide range of prices for items at this year’s auction enabled even more people to participate.  In addition to traditional ad spaces and sports memorabilia, many fun and exciting new items were available. A beautiful pair of Tiffany pearl drop earrings generated quite a buzz.  Other unique items included a Pinehurst Golf experience, a Taste of Tennessee Bourbon Tour, and a Kayak and GoPro camera package.

Thank you to all who generously donated items to the auction and to all who participated in the bidding.  We look forward to an even bigger auction next year to increase the direct impact you have on oral health in America!

Taking Full Advantage of Your Chicago Midwinter Meeting

The Chicago Dental Society Midwinter Meeting is a busy week for the dental industry. It is one of the first major dental meetings of the year and a growing international dental event. Take full advantage of your time in Chicago by attending a number of DTA sponsored activities that are designed to enhance your Chicago Midwinter opportunities.

Arrive in Chicago on Wednesday, February 25th for the Future Trends Forum followed immediately by the DTA Preview Show at the Hyatt Regency McCormick Place adjacent to the McCormick Center and Chicago Dental Society Midwinter Exhibition. This year, the Future Trends  Forum takes on a provocative subject –gray market sales. Find out how companies are dealing with the challenges of unintended dental products sold or re–imported back into the US market. Learn from leading professionals how they address this issue. Understand how the implementation of Unique Device Identification (UDI) impacts the sale of gray market dental products.

Immediately following the Future Trends Forum is the Preview Show, the best business-to-business event for dental companies in the US. Manufacturers will be highlighting their latest products and small equipment. US and foreign distributors will be attending the Preview Show looking for new companies to partner with and for new technologies to bring to the dental office. This year’s Preview Show offers a number of new innovations including private meeting spaces, sign–up sheets to request a private meeting with a manufacturer (ahead of time or on–site) and VIP passes for attendees who want to beat the competition to meet with table top exhibitors before the crowds arrive.

The following day, the Emerging Leaders are hosting a Wine and Food Pairing – so executives can learn more about serving the proper wines with great food when entertaining clients. A leading sommelier from Midmark Corporation will lead the group through a half dozen different wine tastings and food pairings. This event will be marked by plenty of great food, top wines and a lot of high level networking. The event takes place Thursday evening, Feb 26th at the Omni Hotel, 676 N. Michigan Avenue from 6:30 to 9 pm. Highly recommended for all your sales managers and executive team.

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