A Michigan company is gearing up to launch what it claims is the only FDA-cleared disposable handpiece available in the U.S. The Azenic DHP (disposable high-performance) handpiece received FDA clearance in January 2008 and is indicated for all dental procedures performed with standard metal handpieces.
The DHP is not the first disposable dental handpiece to be developed and commercialized. In the 1990s, two disposable air-turbine handpieces -- the Oralsafe and the Feathertouch -- were evaluated by researchers from Prince Philip Dental Hospital (British Dental Journal, January 1997, Vol. 182:1, pp. 15-21).
— Mac Waldorf, Azenic president
and CEO
But at the time the technology was found to be lacking. "Both brands ... had a number of problems: poor performance, vibration, excessive noise, variability of behavior, [and] poor bearings," the researchers concluded. "Use of these devices is difficult to recommend. Improvement in design seems necessary."
Both products ultimately disappeared from the market. Then, in 2005, Azenic licensed some of the Oralsafe technology and has been working with an OEM design and manufacturing firm in Texas to develop a "new and improved" disposable dental handpiece.
"We spent the last fours years in the design, engineering, and manufacturing of a disposable product that would operate as well as a metal counterpart," said Mac Waldorf, president and CEO of Azenik, which was established in 2005.
Injection-molded plastics
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| The Azenic DHP handpiece. |
The DHP is made almost entirely of injection-molded plastics and resins, said Waldorf, noting that the turbine -- and the rotational speed at which it spins -- requires a different polymer than the body. "The only things made of metal are the bearings inside the head."
Even so, the DHP is designed to function much like its metal counterparts. It is air-driven and connects to standard 4, 5, or 6 screw-on hose connectors. It runs at 325,000-375,000 rpm and can accommodate multiple bur changes. Each handpiece can be used for up to 16 minutes of cutting time in one single-patient setting.
After use, the entire handpiece can be disposed of in the office trash, eliminating the risk of pathogen transmission or sterilization protocol lapses, according to Waldorf. Other advantages, according to the company, include:
- No cleaning or sterilization required
- No maintenance or refurbishment
- No reduction in performance characteristics due to autoclaving
- No noisy, worn-out bearings
In tests conducted by Azenic (but not published), the company compared the DHP with "three of the leading metal handpieces" (all brand new) and found that the disposable handpieces demonstrated 30% greater cutting efficiency and 15% higher power, according to Waldorf.
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Despite the comparisons, however, Azenic is initially marketing the DHP not as a replacement for metal handpieces but as an adjunct. Waldorf envisions the device being used to augment high-volume days, "when the metal handpieces are in the autoclave" or break, or for emergency and after-hours procedures. It would be particularly useful for mobile dental clinics where sanitizing equipment isn't always available, he added. And because each handpiece is disposed of after use, the DHP also offers "peace of mind" for patients and practitioners when dealing with severely immune-compromised patients.
"We find the dental market to be a great industry to work in, but transition and change don't happen overnight," Waldorf said. "We anticipate the dentists will drive the bus in terms of finding applications [for the DHP]."
Azenic plans to do a soft launch of the DHP this summer and is already offering an early adopter program. The product will be formally launched in October in time for the ADA annual conference in Orlando, FL, Waldorf said. Retail price will be $15 per handpiece, and Azenic will initially sell directly to dentists rather than through a distributor.
Some companies in China -- including Hunan Jinme Dental Handpiece, All Pro Disposable Dental Handpiece, Henan Hongtaiyang Instrument, and Huaer Technology -- also offer disposable handpieces. While these products sell for much less than the DHP -- typically $1.50 to $3.50 apiece, as quoted on one website -- they do not have FDA clearance, according to Waldorf.
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