Spectra caries detection device gains FDA clearance

The U.S. FDA has granted marketing clearance to Air Techniques for its Spectra optical caries detection device.

The company first applied for FDA clearance in May 2008 and has exhibited the Spectra at various dental meetings for the past two years, said John Newman, digital products specialist at Air Techniques.

The Spectra optical caries detection device. Image courtesy of Air Techniques.

The Spectra uses a blue-light LED operating at 405 nanometers to identify decay-causing bacteria on individual teeth. A shroud hood spacer on the end of the handheld device is placed over the tooth like a cap, blocking any ambient light that could give a false reading, Newman explained.

"It helps focus the light being shown on the tooth and reflected back," he told DrBicuspid.com. "It also gives us the ability to keep spacing consistent across the board. And, unlike competing products, where you have to pinpoint the fissures, we are capturing the data on the entire occlusal surface."

When the tooth surface is illuminated, porphyrins (special metabolites of cariogenic bacteria) will fluoresce red, while healthy enamel fluoresces green, according to the company. When used with Air Techniques' proprietary Visix imaging software, a live monitor image will highlight the carious lesions in different colors and will also report potential caries severity on a scale from 0 to 5.

"The Spectra gives numerical values that coincide with colors to each of those values," Newman said. "Sound enamel will fluoresce green; once you start to see the buildup of the caries bacteria, that is where the colors and numeric values come into play, going from blue to red, orange, and yellow, with yellow being the most severe."

John Flucke, D.D.S., who writes and blogs regularly about dental technologies and participated in some of the Spectra clinical trials, noted on his blog August 20, "While there are other high-tech devices that can find decay, Spectra is the only one that can do it visually, allowing the area to be tracked over time for small lesions. The colors correspond to the depth of the decay so that it is easy to judge when a lesion can undergo remineralization therapy and when restorative options should be initiated."

Air Techniques is ready to start filling orders now, Newman said. The company will display the product, which sells for $4,995, at the upcoming California Dental Association meeting, September 10-13, in San Francisco.

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