New Disposable High-Speed Dental Drill Receives FDA Clearance

KALAMAZOO, MI .Axenic Dental, Inc., announced that it had received U.S. Food and Drug Administration (FDA) clearance to market a patented new disposable high-speed dental drill, the Axenic DHP (Disposable High Performance).

"FDA clearance to market is an important step forward in making an important option available to dentists and patients concerned with quality, more individualized care, further reduction in the possibility of patient to patient cross contamination, and overall greater patient
peace of mind," said Eli Thomssen, President and CEO of Axenic Dental, Inc., in announcing the achievement of this regulatory milestone.

In listing the advantages of the newly approved handpiece, Thomssen cited like-new performance for every use, guaranteed sterility and reduction in clean up and sterilization procedures required after each patient. He also noted that the Axenic DHP met or exceeded the critical operating specifications for marketed metal handpieces in extensive laboratory testing; reduced overall labor costs for dental practices by eliminating the need for handpiece maintenance, cleaning and sterilization; and was designed for ease of use, handling, comfort and maneuverability.

The Axenic DHP was developed and laboratory tested over a period of two years. Input was received from thought leaders in the field of dentistry as well as from leading dental practices. The engineering for the new product was done at Avail Medical Products in Dallas, TX.

"Clearly, there has been a trend toward the greater and greater use of, disposable instruments for many different dental procedures," Thomssen noted. "In focus groups, dentists and patients recognized the benefits in safety as well as savings in time and expense associated with cleaning and sterilization required to prevent cross contamination."

"Dentistry has focused attention on patient safety and comfort for many years and, as a result, great improvements have been made through measures such as the increasing use of disposables in a wide range of procedures," according to John Molinari, Ph.D., a nationally recognized expert in the field and a member of the advisory board for Axenic Dental, Inc.

According to Thomas Veryser, D.D.S., MHSA, Executive Director of Michigan Community Dental Clinics, Inc., a fast growing network of 14 public health dental clinics in Michigan, "The availability of a high performance disposable dental drill like the Axenic DHP represents an opportunity for considerable savings in reduced sterilization and maintenance costs for high volume practices."

In addition, Dr. Veryser, who is also a member of the Axenic advisory board, points out that a disposable dental drill would be especially valuable for hospital dentistry where dental equipment and procedures are not frequently used. Axenic Dental, Inc., is a product development company committed to the discovery, development and regulatory approval of innovative dental products for unmet medical needs. It is a portfolio company of the Apjohn Group, a life science business acceleration firm located in Kalamazoo, MI.

Thomssen said that Axenic Dental is currently in preliminary discussions with major dental supply companies regarding the sales and marketing as well as distribution of the new product to dentists. He also noted that actions to secure regulatory clearance for the European Union and Canada are underway.

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