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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...
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...
- 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...
- May 2013
Among the newer features in digital impression-taking systems are smaller-than-ever intraoral devices and color technology. Also: several new players enter the market.
Zirconia-reinforced materials are a new trend, and expanded options for pre-colored zirconia and ceramics for full contour restorations offer both efficiency and esthetics. Plus, a new type of material: a biocompatible, millable resin on which the final restoration can be built; there's no need for casting or pressing.
- April 2013
All-ceramics, implants, profit erosion and other hot topics inspired dialogue during the biggest weekend of the year.
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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...
- October 2012
It would be downright silly to suggest anyone actually likes taxes so itâs no surprise that a coalition of 400 medical device manufacturers voiced its opposition to the 2.3% excise tax on medical devices slated to go into effect January 1, 2013.
- 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...
- 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
The NADLâs analysis of the new healthcare legislation reveals a 2.3% excise tax applicable to the selling price of completed dental restorations.
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.
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.
The writing on the (Great) wall. Laboratory owner Flemming Behrend, CDT, MDT, Fellow ICOI, shares his firsthand perspective...
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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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One of the Chinese laboratories that is marketing to the U.S. is DentUSA, a full service, 300-plus-technician laboratory in Shanghai.
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.
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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
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.
In our price-competitive, technician-deprived industry, offshore outsourcing is becoming an increasingly viable business strategy.
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LMT contributing writer Mark Murphy offers advice for lab owners who need a boost in a difficult economic climate.