As seen in December 2012 Orthodontic Products Magazine
Posted in Ad, Orthodontic Appliances
Tagged EZ-Align
As seen in November 2012 Orthodontic Products Magazine
Posted in Ad, Orthodontic Appliances
Tagged Modified Tandem, Orthodontic Products Ad
Using Your Scanner to Make Appliances
DynaFlex (www.dynaflex.com) has been working with Cadent for several years on transferring .stl files to their laboratory to make appliances. The feedback on the process has been very positive especially as it relates to Hawleys. DynaFlex has also developed a process to make banded appliances from these scans as well. DynaFlex charges $8.75 per arch to accept and print each arch.
You can learn more by contacting Gary Johnson, Vice President of DynaFlex at 636.544.2145 or email at garyj@dynaflex.com
Posted in Article
Tagged digital models, iTero, scanners
DynaFlex® Awarded GSA Schedule 65IIC Contract
DynaFlex has been awarded Dental Equipment & Supplies (Federal Supply Group…65IIC) contract by the U.S. General Services Administration (GSA), the procurement arm of the federal government.
FedBizOpps.gov….Link
https://www.fbo.gov/index?s=opportunity&mode=form&id=fb4228c3bcaf77e3431474d95d477919&tab=core&_cview=0
St. Ann, Missouri, USA, August 08, 2012
For Immediate Release — “Today’s announcement marks another significant milestone in DynaFlex history,” said Darren Buddemeyer President and CEO of DynaFlex.
The GSA establishes long-term, government-wide contracts with commercial vendors to streamline and standardize the process of procuring products and services for the entire federal government. DynaFlex’s inclusion as a GSA Schedule 65IIC vendor enables all government agencies to obtain Dental Equipment & Supplies, and Services at approved pricing and license terms from a trusted vendor.
The GSA Schedule 65IIC award is the culmination of a rigorous process in which the GSA carefully evaluates companies to determine their proficiency and suitability for providing products and/or services to the federal government. The assessment covers an array of a corporation’s capabilities, including, but not limited to, organizational structure, performance history, and customer satisfaction. In awarding DynFlex a GSA Schedule 65IIC contract, the federal government has determined that the company is recognized as a preferred vendor fully authorized to conduct business directly with federal government agencies.
“DynaFlex is very pleased to offer our products and services to Government agencies. Not only does the federal supply schedule have the potential to be a significant growth driver for DynaFlex, it also represents a fundamental step forward in ensuring that our government obtains the best equipment, supplies, and services. It is a winning situation for DynaFlex and for the Government,” said Gary Johnson, Executive Vice President of Marketing and Sales.
Federal, State and local agencies can obtain information about DynaFlex’s GSA Schedule 65IIC contract services on the GSA Advantage web site at: www.gsaadvantage.gov (search for Contract Number: V797P-2252D) or by contacting DynaFlex directly at (866) 346-5665. DynaFlex services are offered under the Special Item Numbers (SIN) C-17, C-18, C-31(b), C-35, C-INP, Dental Equipment, & Supplies and the award is effective August 15, 2012 to August 14, 2017.
DynaFlex is an ISO 13485:2003 & MDD 93/42/EEC Certified Company.
For more information contact:
DynaFlex®
Matt Malabey
ISO and Quality Manager
mattm@dynaflex.com
Posted in Press Release
DynaFlex® gets 510(k) Clearance for EZ-Align®
St. Ann, Missouri, USA, August 15, 2012
For Immediate Release — “Today’s announcement marks one of the most significant milestones in DynaFlex history,” said Darren Buddemeyer President and CEO of DynaFlex.
“Not only does EZ-Align® (K121396) have the potential to be a significant growth driver for DynaFlex, it also represents a fundamental step forward in the sequential aligner technology using our proactive management style.”
“Developing medical devices can be a major challenge for any organization, but for us to have achieved 510(k) clearance from the FDA is an outstanding accomplishment which we are very proud of as a company. These achievements further illustrate the DynaFlex commitment to regulatory requirements, and assurance that our devices are made with utmost safety requirements.
FDA 510(k): Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. It is a rigorous and arduous documentation and compliance process.
About DynaFlex
DynaFlex is a leading provider of Orthodontic Products, Orthodontic Custom Lab Manufacturing, Sleep Apnea Appliances, and Digital Orthodontic Products and Services.
Established in 1965, DynaFlex is now one of the fastest growing Orthodontic Supply & Lab providers in the industry. We are proud to provide “above and beyond” outstanding customer service, combined with the best products, high- quality manufacturing, state of the art technology, and a stellar, market- leading unique proactive leadership approach.
DynaFlex is an ISO 13485:2003 & MDD 93/42/EEC Certified Company.
DynaFlex®
Matt Malabey
ISO and Quality Manager
mattm@dynaflex.com
Posted in Press Release
Tagged EZ-Align
DynaFlex gets ISO 13485:2003 & MDD 93/42/EEC Certification
St. Ann, MO., June 5, 2012
“This is an outstanding achievement for everyone at DynaFlex and a testament to our focus on quality” said Darren Buddemeyer, CEO of DynaFlex. “Gaining ISO certification can be a major challenge for any organization, but for us to have achieved both ISO 13485:2003 and MDD 93/42/EEC simultaneously is superb and an accomplishment we are very proud of as a company. These achievements further illustrate that the management systems we have built within DynaFlex, and the processes through which we care for our clients are to the very highest international standards.” Buddemeyer concluded.
ISO 13485:2003 is the internationally recognized standard for quality management within a business in the medical device industry. It provides a systematic and common sense approach to ensure that the activities within the business are controlled, aiming to consistently achieve customer satisfaction by meeting their requirements and expectations.
MDD 93/42/EEC (The MD Directive) is a ‘New Approach’ Directive and consequently, in order for a manufacturer to legally place a medical device on the European market, the requirements of the MD Directive have to be met. Manufacturers’ products meeting ‘harmonized standards’ and have a presumption of conformity to the Directive. Products conforming to the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.
About DynaFlex DynaFlex is a leading provider of Orthodontic Products, Orthodontic Custom Lab Manufacturing, Sleep Apnea Appliances, and Digital Orthodontic Products and Services. Established in 1965, DynaFlex is now one of the fastest growing Orthodontic Supply & Lab providers in the industry, providing outstanding customer service, combined with the best products, high quality manufacturing, state of the art technology, and a market leading unique proactive leadership approach.
For additional information, please contact:
DynaFlex®
Matt Malabey
ISO and Quality Manager
mattm@dynaflex.com
Posted in Press Release
