FDA clears OrthoAccel’s AcceleDent Optima

OrthoAccel Technologies said today that the FDA approved its AcceleDent Optima device as the 1st and only connected orthodontic device that incorporates usage monitoring and direct messaging through the AcceleDent app.

The device is OrthoAccel’s 3rd-gen vibratory accelerated orthodontic product to be commercially available within the last 6 years. Optima is small, lightweight, waterproof and can connect with smartphones and tablets, according to the company.

Optima uses OrthoAccel’s SoftPulse technology to produce pulsating forces that stimulate cellular activity and speed up bone remodeling.

“I offer AcceleDent because the science supporting acceleration using low-pulsatile forces, such as those employed by AcceleDent, has existed for 40 years,” Dr. Straty Righellis said in prepared remarks. “AcceleDent Optima will make it easier for orthodontists to monitor and encourage patient compliance because of the usage data that syncs to the AcceleDent App.”

The AcceleDent App allows patients to track their usage and set reminder notifications. Orthodontists and healthcare practitioners can access real-time usage data for each of their AcceleDent patients through a customizable web portal.

“The benefit of integrating low-force pulsation, such as AcceleDent, as my sole accelerated treatment option is that it’s noninvasive, it gives me added control through all three stages of treatment and it does not disrupt the normal patient flow of my orthodontic office,” Righellis added.

AcceleDent Optima has also been cleared by Health Canada and has CE Mark approval in the European Union.

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