DLP Newsbites 

Documented Cases of Lead Contamination in Off Shore Dental Laboratory Restorations

Feb. 26, 2008

Recently, NADL was contacted by a dental patient in Ohio who has documentation of lead contamination in her dental restoration. The affected patient, a senior citizen, received a three-unit dental bridge from a dentist in Ohio. After having an adverse reaction to her dental work, and having it removed, the dentist disclosed that the prescription was sent to an offshore dental laboratory and disclosed to the patient that the restoration was made in China. The patient then had the restoration sent to a chemical laboratory for analysis. The documentation of the dental material analysis of this patient’s restoration showed unsafe levels of lead in the porcelain on the restoration. 

This case has attracted the attention of an Ohio television reporter who was already working on a story about offshore dental laboratory work. As part of the reporter’s investigative research for the story, the TV station ordered a series of crowns from several offshore dental laboratories. One of those restorations contained 210 parts per million of lead in the materials. The U.S. Congress, in response to the toy recalls in 2007, lowered the acceptable levels of lead in toys to 90 parts per million.

The testing of these restorations for the reporter’s investigation was conducted by a chemical research laboratory in Ohio and, at the suggestion of NADL, at the Boston University School of Dental Medicine. In addition to the documentation of lead, the chemical analysis revealed the restoration contains traces of radioactive isotopes.

The reporter contacted NADL and interviewed co-executive director, Bennett Napier, CAE, for this story. Others interviewed include the attorney for the patient in Ohio; a lead expert; a spokesperson from the Ohio Dental Board, a Columbus dentist and laboratory owners from central Ohio. The TV report contains position statements or quotes from the American Dental Association and the U.S. Food and Drug Administration.

WBNS 10 TV in Columbus, Ohio, will broadcast this story Wednesday. You can view the full investigative report Wednesday evening at the station’s Web site www.10tv.com. The owners of the regional television station also own the Columbus Dispatch, the local daily newspaper. An article about the story will be run in that paper’s Thursday, February 28th edition.

It is likely that with the significance of this story it may be picked up by other media outlets in large metropolitan areas by the end of this week and possibly may be picked by national news media outlets as well.

NADL’s Position:

NADL has worked with the U.S. Food and Drug Administration to promote patient safety and ensure laboratories have a voice in any regulation of the industry. NADL is on record supporting regulations that assure patients their restorations are safe for use, regardless of where they are manufactured. NADL’s position has been presented consistently to the American Dental Association since 2003.

The National Association of Dental Laboratories believes that every dental patient has a reasonable expectation that the dental restoration placed in his or her mouth is safe, regardless of where it is manufactured. Therefore, in an attempt to provide the necessary documentation for disclosure as well as to document competency, the NADL strongly supports the following:
The  necessity of at least one Certified Dental Technician (CDT) in each dental  laboratory.  
The  necessity that all dental laboratories register with either the U.S. Food and  Drug Administration or an appropriate state governmental agency.  
The  written documentation of all materials included in a final restoration and the  point of origin (country and laboratory) where the restoration was  manufactured.  
The  necessity that each of these items be documented in the patient’s  record.

Additional Information:

NADL informed the American Dental Association’s executive leadership so they could tell their members about this pending story and possible outcomes including the public’s response. 

The ADA will be sending out an alert to its members this week sharing guidance about what questions to ask dental laboratories relative to outsourcing activity and statements of assurance on material content of dental restorations. NADL member’s laboratories should be prepared for such requests.

Additionally, it is expected that state dental societies will be discussing possible regulatory options to address this issue at the state level in state dental practice acts. State dental societies may be contacting your state’s dental laboratory association about possible collaborative efforts or to seek additional information. NADL members are encouraged to share NADL’s model bill for state regulation with state dental societies or inquiring dental clients that may request a template for state regulation. Members of the laboratory industry may download this document from NADL’s Web page at www.nadl.org.

Dental laboratories should be prepared for increased calls from your dental clients and possibly local media outlets during the next few weeks as this news story circulates the country. NADL will be providing up-to-date guidance documents to our members on the member section of our Web site www.nadl.org <http://pull.xmr3.com/p/377-653D/791046/http-www.nadl.org-.html> to assist you when answering questions. We are committed to keeping our members well informed and prepared.

Sincerely,

NADL Board of Directors and Executive Staff

325 John Knox Road, L103
Tallahassee, FL 32303
800/950-1150 Phone
www.nadl.org 


3M ESPE introduces new Pentamix™ 3  Mixing Unit
ST. PAUL, Minn. – (Feb. 26, 2008) – 3M ESPE announces the introduction of the Pentamix™ 3  Mixing Unit, the latest state-of-the-art automatic mixing unit, featuring faster speeds and a smaller footprint than any other automatic mixing and dispensing system in the industry.  Boasting twice the speed of the Pentamix™ 2 Automatic Mixing Unit, the Pentamix 3 mixing unit offers the ability to utilize a broad range of material viscosities, especially quick setting materials, and consistently provides homogenous, void-free automatic mixing at the touch of a button. 
For more information, please contact:

Brooke Baxley
Karwoski & Courage Public Relations
612.342.9817
b.baxley@creativepr.com

FRIDAY, OCTOBER 26, 2007

NADL Provides aid to California labs affected by wildfire
The National Association of Dental Laboratories (NADL) announced that the
NADL Disaster Relief Fund will provide assistance to dental laboratory
professionals in Southern California affected by the recent wildfires.
“This tragedy is having a significant impact on Southern California,” said
NADL Co-Executive Director Ricki Braswell, CAE. “This is a time when we
count on support from within the industry.” The NADL has more than $30,000 in the fund originally established for Hurricane Katrina relief efforts. In late 2005, the NADL board changed the Katrina Disaster Relief Fund to the NADL Disaster Relief Fund so the NADL and donors could assist other disaster victims in the dental laboratory industry and has since helped victims of hurricanes Rita and Wilma. Donations for the NADL Disaster Relief Fund can be made by contacting the NADL office at 800-950-1150 or through an  Online  Donation Form at www.nadl.org/disaster.cfm. The NADL also has developed an online Assistance Request Form where requests
for help can be made. Requests for assistance will be facilitated  on a
first come, first serve basis and will be for a flat amount  of assistance.
Both forms also can be downloaded and submitted by mail or fax. For more information please visit www.nadl.org.


FRIDAY, SEPTEMBER 28, 2007

Atlantis Components Inc. Acquired by Astra Tech
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Atlantis Components, Inc., leader and innovator in the dental implant market, is pleased to announce it has been acquired by Astra Tech AB the leading Swedish medical technology company, a subsidiary of AstraZeneca, for USD 71 million in cash. This acquisition allows Atlantis to increase its market penetration of the dental market while further enhancing Astra Tech’s ability to provide comprehensive solutions including digital dentistry needs.
In the past few years, Astra Tech has grown at a rate of over 40 percent a year while the global market for dental implants is showing an average of 18-20 percent growth. Growing demand for attractive functional tooth replacements has meant that the U.S. market for dental implants is approaching $700 million and is estimated to grow close to 20 percent each year for the coming years and reach an estimated $1.2 billion in 2011. More than 1,500,000 dental implants were placed in the U.S. last year.
“The two companies complement each other perfectly. Through the acquisition of Atlantis, we can offer all dentists working with implants an optimal solution, in terms of both esthetics and function,” says Scott Root, President and CEO, Astra Tech Inc., North America.
“We will develop a Center of Excellence in the US for esthetics, based on Atlantis’ unique know-how and technology in order to offer advanced digital dentistry solutions,” says Peter Selley.
In 2008, Astra Tech will begin producing Atlantis’ CAD/CAM abutments for the European market at its headquarters in Mölndal, Sweden. The launch and sales in Europe will be handled by Astra Tech’s existing sales organization. For more information, please visit www.atlantiscomp.com.

MONDAY, SEPTEMBER 24, 2007

3D Systems SLA® Technology Selected for Dental Model Production
ROCK HILL, South Carolina, September 19, 2007 - 3D Systems Corporation (NASDAQ: TDSC), a leading provider of 3-D Modeling, Rapid Prototyping and Rapid Manufacturing solutions, announced today that 3M has selected 3D Systems’ Viper™ Pro SLA® technology for the digital production of dental models. This Rapid Manufacturing platform will seamlessly integrate with the soon-to-be-released 3M™ ESPE™ Lava™ Chairside Oral Scanner (C.O.S.).   

Under an engineering development agreement, 3D Systems is co-developing a proprietary Rapid Manufacturing methodology for the production of accurate, durable models of individual teeth and arches with crisp resolution that combines the 3M ESPE Chairside Oral Scanning technology with the Viper™ Pro SLA® System and a new proprietary Accura® SL Material.    Selected by 3M for its accuracy, repeatability, detail and production capacity, the manufacturing capable Viper™ Pro SLA® System converts proprietary materials and composites into solid cross-sections, layer by layer, until three-dimensional models are built.

Additionally, 3D Systems and 3M ESPE developed a proprietary new material specifically for this high-volume, high-resolution application. The new Accura® Material exhibits high detail, higher durability and offers superior resolution and precision.    3M ESPE will introduce the Lava™ C.O.S. to dentists in North America and Europe in 2008. The Lava™ C.O.S. will provide an alternative to the traditional dental impression process and enable the high-speed 3-D motion capture of tooth anatomy used to create PFM and all-ceramic crowns and bridges manufactured by dental labs."This agreement has made 3D Systems the Rapid Manufacturing provider of choice for digital dentistry,” said Abe Reichental, 3D Systems’ president and chief executive officer. “Just as we have pioneered Rapid Manufacturing for the hearing-aid industry, we are pushing the envelope within the dental arena with our technology. We are thrilled to work with 3M ESPE on this useful solution that benefits both dental professionals and patients.”

WEDNESDAY, SEPTEMBER 19, 2007

Cadent To Debut 'Next Generation' iTero Digital Impression System at American Dental Association's 148th Annual Session

New Upgrades Include Faster Scanning Time, Expanded Shade Libraries, Modified Foot Pedal Design

Carlstadt, N.J. - September 19, 2007 - Cadent, the leading provider of 3-D digital solutions for the orthodontic and dental industries, today announced that the 'next generation' iTero Digital Impression System is now available for purchase. It will be unveiled at the American Dental Association’s (ADA) 148th Annual Session, which will take place at the San Francisco Moscone Center from September 27-29 (booth number 2602). iTero is the first digital impression solution for the fabrication of all dental restorations and material options.

The added features and benefits in the software update include:

50% reduction in overall digital capture and scan time

50% faster real-time display of 3-D digital model

Expanded shade library to include vita 3-D master

Background color options in both solid colors and gradients for added depth of 3-D models

Modified foot pedal design for increased stability during scanning

Prior to iTero, first-generation digital impression systems have been hindered by their narrow application to only a small fraction of common restorative procedures, as well as a capital-intensive cost structure. iTero breaks new ground both clinically and economically with technology that can be used for all restorative options and a lab-based solution that significantly improves quality and service. For more information, please visit www.cadent.co.il/.

3M ESPE Evolves the Lava™ Brand Evolves to Become the Company’s Global Digital Restoratives Brand

Lava™ Products are now part of the Lava Precision Solutions Portfolio

Intending to extend the company’s reach into the digital restorative dental space, 3M ESPE announces the extension of the Lava™ Brand.