That’s the question on everyone’s mind these days, especially since the NADL released an alert on the in-house milling of custom abutments in November. Here are the details, including the NADL’s alert, the FDA’s heightened enforcement efforts, and responses from the marketplace.
- November 2015
The sleep apnea market presents some unique challenges for labs. LMT explains what you need to know to navigate this niche.
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- March 2015
Fifty-five percent of our State of the Industry 2015 survey respondents have recently changed their business model to increase profitability, gain new clients and be more competitive. Five of our respondents share their stories.
- April 2014
PEEK—poly-ether-ether-ke-tone—was the talk of the IDS in Cologne last year; now, it’s come to the U.S. in the form of the JUVORA Dental Disc made from PEEK sourced directly and exclusively from Invibio® Biomaterial Solutions, a global leader of PEEK biomaterials. Available from JUVORA Inc., the disc received FDA clearance for milling frameworks for complete and partial removable dentures and implant overdentures earlier this year.
“PEEK has had some use historically in dental applications such as abutments and healing caps. However, now with the JUVORA Dental Disc, dental professionals in the U.S. have the ability to use CAD/CAM technology for precision designing PEEK frameworks for removable prostheses,” explained Nicole Czechowski, Business Development Manager, JUVORA Dental Innovations.
The JUVORA Dental Disc is lightweight, biocompatible, radiolucent, highly wear and abrasion resistant, and has elastic properties similar to that of human bone. JUVORA’s...
- March 2014
In 2010, the NADL’s analysis of the new healthcare legislation revealed that a 2.3% excise tax would be applicable to the selling price of completed dental restorations beginning in 2013.
Vague terminology in the legislation indicated that the 2.3% tax would be payable by the manufacturer, producer or importer but didn’t specifically define those terms. Given the FDA’s previous classification of dental laboratories as medical device manufacturers, the conclusion was that the tax would apply.
The news generated a growing alarm over the next several months as laboratory owners sought clarification on what the tax would mean to them. Despite the efforts of the NADL, ADA and nearly a dozen other allied dental organizations to have dental devices excluded from the tax, the IRS denied the request at a public hearing in Washington D.C. in May 2012.
However, at virtually the last minute—on December 4, 2012—the IRS released its Final Rule on the Medical Device Tax,...
- September 2013
A year ago, Whip Mix Corp. promoted its Vice President of Manufacturing, Jim Myers, to President of the company, succeeding Allen Steinbock, the grandson of Whip Mix Founder Edmund Steinbock, Sr. This promotion makes Myers the first non-family member President in the company's history. LMT travelled to Louisville, KY, to talk with Myers about his new position and where the company is headed.
LMT: As President, how has your role changed?
Myers: For 11 years, my priority was our manufacturing processes; now, it's more focused on customer needs and opportunities. I have much more interaction with our sales team and Whip Mix customers.
LMT: What stands out to you regarding your customers?
Myers: The most striking thing about our laboratory customers is their level of energy, dedication and desire to improve their businesses. Rather than hoping digital technology won't affect them, they're rolling up their sleeves, re-inventing themselves and embracing new technology.
LMT: Tell us more...
- April 2013
All-ceramics, implants, profit erosion and other hot topics inspired dialogue during the biggest weekend of the year.
At the Cal-Lab Meeting in Chicago, Safelink's Gary Morgan, CDT, offered an update on various regulatory issues, including OSHA, the FDA and the Medical Device Tax. Here's an overview:
OSHA has revised its Hazard Communication Standard. "This is a major change you need to be aware of and address right now," said Morgan, noting that OSHA is making enforcement a priority and laboratory inspections and penalties are on the rise. As part of the new standard:
Laboratories must update their hazard communication plan which details how staff should safely work with chemicals. "You need to figure out what you have: conduct an assessment, determine safe practices, create a written program and label all chemicals with their contents," said Morgan.
OSHA has also adopted a Global Harmonization System (GHS) that requires images or pictograms on dangerous, corrosive or toxic substances. Manufacturers and distributors are required to label original containers and the lab should either provide the same...
- August 2012
2.3% Excise Tax Goes into Effect in 2013; FDA Registration Fees Increase
Since the Health Care and Education Reconciliation Act was signed into law in May 2010, laboratory owners have been wondering whether the 2.3% excise tax on medical devices applies to dental restorations. Despite the efforts of the U.S. House of Representatives, NADL, ADA and nearly a dozen other allied dental organizations to have dental devices excluded from the tax, the IRS denied the request at a public hearing in Washington D.C. in May. "Effective January 1, 2013, it's prudent for dental laboratories to be prepared for remitting a 2.3% excise tax on sales of finished devices," says Bennett Napier, CAE Executive Director, NADL.
According to an analysis by Reed Smith, LLP, the NADL's Washington, D.C.-based law firm:
- The tax applies to the finished device rather than components. For example, if Laboratory A outsources a partial framework to Laboratory B, there would be no tax due on the transaction. The tax only...
- June 2011
On June 22, AstraZeneca announced that it has agreed to sell its Astra Tech business to Dentsply for approximately $1.8 billion in cash.
- April 2011
One of the Chinese laboratories that is marketing to the U.S. is DentUSA, a full service, 300-plus-technician laboratory in Shanghai.
As obstructive sleep apnea becomes a more commonly diagnosed disorder, the demand for oral appliance therapy is on the rise, creating a niche market for laboratories. LMT takes a look at this blossoming field.
In our price-competitive, technician-deprived industry, offshore outsourcing is becoming an increasingly viable business strategy.
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The current economic turmoilâwhich many predict will affect our growth through 2010âhas created a ravine through an otherwise positive trend line in our well-regarded industry.
An overview of disclosure, FDA registration and regulations that every laboratory owner needs to know.
In light of the dramatic rise in imports from overseas laboratories in the past several years, the FDA has become concerned that these low-cost offshore restorations might not contain FDA-approved materials that are legally required to ensure patient
The NADLâs analysis of the new healthcare legislation reveals a 2.3% excise tax applicable to the selling price of completed dental restorations.
With less than 300 orthodontic laboratories in the U.S., the specialty is a quintessential niche market and one that has experienced steady growth for years.
While the FDA is paying unprecedented attention to the dental laboratory industry, only half of laboratory owners and managers are familiar with the agencyâs Good Manufacturing Practice requirements.
LMT contributing writer Mark Murphy offers advice for lab owners who need a boost in a difficult economic climate.
Whether your laboratory is high-end, low-end or somewhere in between, your clients expect consistency on each and every case they receive from your laboratory.
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