NADL will be hosting the 2nd Quarter Webinar on Wednesday, June 20, 2018 from 2:00pm-3:00pm EST. This webinar will be one (1) hour in length and will be NBC-approved for Regulatory Standards credit. The webinar will be FREE for NADL Members and $35.00 for non-members.
“In Simple Terms: What You Need to Know About the FDA” presented by Tim Torbenson
- Understand why the FDA is now requiring CAD/CAM dental labs to implement a Quality Management system that complies with the FDA’s Title 21 CFR 820?
- Am I exempt? 5 Simple Questions.
- What is Title 21 CFR 820?
- What is a Class II Medical Device as it relates to the Dental Laboratory?
- What is a Quality Management System?
- How do I get my lab compliant with the FDA?
- What does it cost and how does it benefit my lab?
Tim Torbenson has over 41 years’ experience in the dental industry with the past 31 years dedicated to the restorative processes involving Dental implants. He has a diverse experience with medical device manufacturing, sales, management and regulatory affairs. Tim brings his regulatory experiences from his time at Attachments International, Glidewell Dental Laboratories and most recently Integrated Dental Systems where Tim oversaw the development of 5 implants systems through design, production and their regulatory processes. Tim is now the president of evo820, a regulatory consulting firm dedicated to helping dental laboratories meet FDA requirements through a practical and affordable process.
National Dental Associations Celebrate June as Dental Technician and CDT Appreciation Month
The National Association of Dental Laboratories (NADL) and the National Board for Certification in Dental Laboratory Technology (NBC) celebrate June as Dental Technician and Certified Dental Technician (CDT) Appreciation Month.
"I tip my hat to my fellow Certified Dental Technicians as we celebrate CDT Appreciation Month!” said Denise Burris, 2018 NBC Chair and NADL board member. “The commitment required to earn your CDT designation is a direct reflection of your pride in yourself, your craft and especially to the patients you serve. It is a process that acutely defines your desire to elevate your skills to a professional level. I share in your dedication!”
Dental technicians bring considerable experience and subject matter expertise in the areas of dental materials, technology utilization, shade verification and restorative dentistry. Although generally operating behind the scenes of the oral health team, dental technicians are a crucial part of ensuring delivery of quality dental care.
Robert Savage, 2018 NADL Board President shared, “Drake Dental Lab has had a long tradition of encouraging the pursuit and attainment of the designation of CDT. Our founder Billy Drake, CDT achieved his 40-year certificate this past January and today Drake employs over 17 CDT’s with more working hard to complete the process. We believe that the Certified Dental Technician title demonstrates a willingness for continued skill and career advancement which is paramount in fulfilling our mission of dental excellence. Congratulations to everyone who has worked hard to achieve this status.”
NADL seeks to inform dentists and patients of the important role of the dental laboratory technician and dental laboratory through its What’s In Your Mouth campaign. In the U.S., most states set no minimum standards for persons to be employed as dental technicians. In fact, only four states in the U.S. require either certification or continuing education for dental technicians.
The NBC is an independent certification organization dedicated to improving the quality of dental laboratory technology through voluntary testing and certification of dental laboratories and technicians. This is the only voluntary certification program for dental laboratory technicians recognized by the American Dental Association.
The CDT designation demonstrates a mastery of the knowledge and applied skills needed in dental technology. It illustrates a technician's commitment to the field of dental technology and demonstrates their knowledge in six specialty areas: ceramics, complete dentures, crown and bridge, orthodontics, partial dentures and implants.
NADL is the unified voice of the dental laboratory industry supporting dentistry and serving the public interest by promoting high standards. NADL accomplishes this by providing programs, services and networking opportunities to meet the evolving technical, educational, professional and business needs of dental laboratories.
Please contact Meghan Brasher at (800) 950-1150 or by email at firstname.lastname@example.org to help celebrate!
National Association of Dental Laboratories (NADL)
News Alert – April 9, 2018
Proposed Tariffs on Imported Dental Laboratory Restorations
Preliminary analysis of USTR-2018-0005 applicability to dental laboratories
On April 3, 2018, the Office of the U.S. Trade Representative (USTR) Notice proposed imposing an additional duty of 25 percent on a list of products from China.
Read the notice at https://ustr.gov/sites/default/files/files/Press/Releases/301FRN.pdf
The notice sets a public comment period through May 11, 2018 and a public hearing is to be held on May 15, 2018.
The products that will be subject to the 25% additional duty are listed using subheadings of the Harmonized Tariff Schedule of the United States (HTSUS).
The subheadings 9021.21.40 and 9021.29.80 are included in the list of products. (See USTR 2018-0005 at page 54)
Subheadings 9021.21.40 and 9021.21.80 include dentures, crowns, abutments, implants, fixed bridges, temporary inlays, onlays, veneers. The subheading ending in 40 applies if the item is considered made of plastic and the sub heading ending in 80 applies if made of something other than plastic. While subheading 9021.21.80 is not currently listed in the USTR Notice, it is not entirely clear if the USTR’s Final Determination will apply the tariff to all 9021.21 “Artificial teeth and dental fittings, and parts and accessories thereof” or to just those made of plastic.
NADL's analysis of applicability to dental laboratory products is based on the outcomes of prior Tariff Classification Rulings.
One such ruling can be viewed at https://rulings.cbp.gov/detail.asp?ru=800171&ac=pr
If the USTR’s proposal becomes effective, then dentures, crowns, abutments, implants, fixed bridges, temporary inlays, onlays, veneers that come from China will be subject to an additional 25% tariff.
What is the impact on the actual cost of imported restorations, if the tariffs become effective?
If a dental laboratory or other purchasing entity pays $20.00 for a Chinese crown currently, then if the tariff becomes effective they will now pay $25.00.
The duty is levied at the time of import and is paid by the importer of record.
The Tariff is calculated on the transaction value which would typically be the price the importer is paying.
Definition of Transaction Value located at https://en.wikipedia.org/wiki/Customs_valuation#Transaction_value
What is the effective date of the Tariff? Could the proposed Tariff be repealed before it goes into effect?
No tariffs take effect until USTR issues a Final Determination. The USTR’s Final Determination could change the amount of the tariff to be charged, or if they are using this as some sort of bargaining chip to reach another agreement, they could back off of the China tariff entirely.
Since May 22, 2018 is the due date for submission of post-hearing rebuttal comments, presumably USTR would wait until after they reviewed those comments before issuing a Final Determination.
If the USTR does go forward with the China tariff, the USTR’s Final Determination wouldn’t come out till probably June 2018 at the earliest and then may allow some number of days from when the Final Determination is issued before the effective date when any tariffs needs to start being paid. This means any proposed tariffs likely wouldn’t take effect until mid-June or early July.
What is NADL’s position on the proposed tariffs?
NADL’s Board of Directors meets later in April and will be discussing the proposed tariffs. The Board of Directors will determine any position it may take and consider any public comments it may submit for the public comment process at its upcoming Board meeting.
The NADL will continue to release updates to its membership and interested parties based on future USTR actions.
NADL Awards presented at the Vision 21 Meeting in Las Vegas
NADL honored the outstanding contributors to dental laboratory technology at the annual Vision 21 Meeting on Friday, January 18, 2018 at The Palms in Las Vegas, Nevada. Winners were nominated by their peers and were selected based on an objective point system.
NADL Awards Included:
NADL Supplier Member of the Year
The Argen Corporation
This award is presented to an NADL member manufacturer/supplier company that has made significant contributions and demonstrated leadership in relation to working in the dental laboratory industry.
NADL Laboratory Member of the Year
Bayou State Crown and Bridge, Lab, Inc., CDL, DAMAS
This award is presented to an NADL member laboratory that has made significant contributions and demonstrated leadership in relation to working in the dental laboratory industry.
NADL Hall of Fame Award
This award is presented to an individual that has made contributions to the dental laboratory profession in general. This award holds NADL's highest honor.
Excellence in Education - Laboratory
ROE Dental Laboratory, CDL, DAMAS
This award recognizes a dental laboratory that has provided services to the dental technology industry in the furtherance of education.
Excellence in Education
Jim Collis, CDT
This award recognizes an individual that has provided services to the dental technology industry in the furtherance of education.
2018 CDT of the Year
Patrick Pellett, CDT
This award presented by the National Board for Certification in Dental Laboratory Technology (NBC), recognizes an individual Certified Dental Technician (CDT) who has made contributions to his/her peers and the dental laboratory profession, and has gone above and beyond the call of duty.
Good news for Michigan dental labs. House Bill 5173 specifically exempts dental prosthetics from Michigan’s sales tax. And the best part is the reinstatement of the dental prosthetic sales tax exemption is retroactive to July 1, 2017. This will be a big help to any labs that got the word late and were still trying to figure out if they owe any uncollected sales tax. Michigan dental labs can now say, “farewell sales tax on dental prosthetics, we hardly knew you.”
For the full text of House Bill 5173 as approved by the Governor please see: http://www.legislature.mi.gov/documents/2017-2018/publicact/pdf/2017-PA-0219.pdf
So this means that there is no more sales tax on dental prosthetics and Michigan dental laboratories are still able to claim the industrial processing exemption on qualifying materials used to make them.
Link to the industrial processing exemption rule:
205.54t Exemptions; limitation; industrial processing; definitions.
Links to Industrial Processing Exemption information and forms: