FDA Abutment/Implant Regulation FAQs

FDA Abutment/Implant Regulation FAQs

Posted by on Mar 11, 2016 in Regulatory News | No Comments

At NADL’s V21 conference there was much discussion and many questions related to FDA’s rules for CAD/CAM milling of implant abutments. As a follow-up to JDT’s January article the following are answers to the most common questions that were asked.

NADL to Push Tech Awareness

NADL to Push Tech Awareness

Posted by on Feb 13, 2016 in Regulatory News | No Comments

According to research by the National Association of Dental Laboratories (NADL), only four states in the U.S. require dental technicians to be certified or obtain continuing education. In order to increase awareness of the lack of standards in the dental industry, NADL created the “What’s In Your Mouth?” campaign to inform patients that their dentists might use technicians that lack the skills and knowledge they should have.

FDA Says No To CAD/CAM In-Lab Milling

FDA Says No To CAD/CAM In-Lab Milling

Posted by on Nov 22, 2015 in Regulatory News | No Comments

When FDA began studying the use of CAD/CAM in dental laboratory technology, the FDA’s initial focus was on angulation and the implant/abutment interface. FDA ultimately made clear statements that anyone making the implant/abutment interface is a “manufacturer” as such must obtain 510(k) clearance to do so…

ADA Passes Significant Resolution

ADA Passes Significant Resolution

Posted by on Dec 31, 2013 in Regulatory News | No Comments

Tallahassee, FL: At the recent ADA Annual Session, the ADA House of Delegates passed Resolution 52. This resolution says “Resolved that in order to enhance dental patient health and safety, the ADA urges all state dental boards to register U.S. dental laboratories”. The culmination of ADA taking this step has been more than ten years […]

Senate Votes to Repeal the Medical Device Tax

Senate Votes to Repeal the Medical Device Tax

Posted by on Mar 23, 2013 in Regulatory News | No Comments

The U.S. Senate showing uncommon bi-partisan support, last night overwhelming passed a budget amendment expressing strong support for repeal of The Affordable Health Care Act’s, better known as ObamaCare, 2.3% medical devise tax. The non-binding amendment to the annual Budget Resolution passed 79-20, with 33 Democrats and one Independent joining all Senate Republicans in passing the measure. […]

NADL “Most Domestic Dental Labs Exempt from Device Tax.”

NADL “Most Domestic Dental Labs Exempt from Device Tax.”

Posted by on Mar 6, 2013 in Regulatory News | No Comments

The National Association of Dental Laboratories (NADL) was able to fund a legal analysis of the proposed rule for the Medical Devise Tax that went into effect on January 1, 2013. The final rule, released in December, outlined that the vast majority of devices made by domestic dental laboratories do not meet the IRS’s proposed […]

Dentists Await IRS Devise Tax Rules

Dentists Await IRS Devise Tax Rules

Posted by on Dec 4, 2012 in Regulatory News | No Comments

Washington—Dentists and the dental industry await IRS regulations implementing a 2.3 percent medical device excise tax that takes effect Jan. 1, 2013. The Internal Revenue Service, among other regulatory agencies, is expected to issue post-election rules implementing Affordable Care Act provisions, the excise tax among them. The dental profession and industry are basing member and […]