FDA approves dental waterline filtration system
EAST HILLS, NY — A FILTRATION system that decontaminates waterlines in dental offices has won FDA approval.
The dental unit waterline filtration system from Pall Medical (East Hills, NY), considered a medical device by the FDA, reduces bacteriological contaminants and associated endotoxin from dental waterlines. Prior to the introduction of this system, no method existed — save bleach — to control bacteria and other contaminants in the treatment water dentists use to rinse patients` mouths, according to David Blazo, Pall`s dental business director.
Several factors combine to create contaminants in treatment water, Blazo says, including use of the public water system in dental chair set-ups, long periods in which the water is stagnant in the waterline rubber hosing, and small hosing diameters. What ultimately forms in the waterline is biofilm — a community of bacteria, fungi, amoebae and protozoa — that attaches to the tubing and breeds, resulting in extremely high bacteria counts.
While the Centers for Disease Control has identified common concentrations of 10,000 to 10 million bacteria per milliliter in dental waterlines, the American Dental Association has recommended that treatment water contain no more than 200 bacteria per milliliter, according to Blazo. Pall`s dental waterline filtration system exceeds that recommendation, he says.
“This was a unique opportunity to apply filtration technology, which is very well understood, to create a custom solution for dentists that was also easy to use.”
The system features a reusable housing that attaches to the waterline handpiece hose and a disposable filter element. The filters available for the unit are 0.2 micron pore-rated, bacteria retentive and hydrophobic to prevent airlock.
This is the first product that Pall, a broad-based filtration technology company with other medical-related filtration products, has launched for the dental industry. The company plans to release the product in Europe and Asia later this year.