LED Dental, a wholly owned subsidiary of LED Medical Diagnostics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tuxedo digital intraoral radiography system.
The Tuxedo system produces radiographic images intended to replace analog dental film. The device includes an intraoral sensor and LED's image management software. With an open system architecture, Tuxedo integrates well with most dental practice management systems, according to the company.
"We're excited about bringing our own digital intraoral sensor system to market," stated David Gane, CEO of LED Medical Diagnostics, in a press release. "This launch is consistent with our objectives to expand and diversify our imaging product portfolio with high margin imagining products and services."
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