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Subject: FDA

OrthoAccel's New AcceleDent Optima Receives FDA Clearance


HOUSTON, May 31, 2017 /PRNewswire/ -- OrthoAccel® Technologies, Inc., the leader in accelerated orthodontics, today announced that it has received FDA clearance for its newest accelerated treatment device, AcceleDent® Optima, and will begin fulfilling orders immediately. The next generation of accelerated orthodontics, AcceleDent Optima is the first and only orthodontic device that directly connects patients and practices with usage monitoring, direct messaging and virtual rewards via the state-of-the-art AcceleDent App, which can be downloaded via iTunes and Google Play.

The leader in accelerated orthodontics, OrthoAccel Technologies, Inc., announces that it has received FDA clearance for its newest accelerated treatment device, AcceleDent Optima. AcceleDent Optima is the first and only orthodontic device that directly connects patients and practices with monitoring, direct messaging and virtual rewards via the state-of-the-art AcceleDent App.

AcceleDent Optima is the third generation of vibratory accelerated orthodontic devices to be commercially available from OrthoAccel within the past six years. Designed with enhanced patient convenience in mind, Optima is a smaller, more lightweight device that is waterproof and able to connect with smartphones and tablets through Bluetooth® connectivity. The device's charging case enables patients to wirelessly charge the activator, which has a five-to-seven day battery life.

Like its predecessors, AcceleDent Aura and AcceleDent Classic, Optima is powered by patented SoftPulse®  Technology, producing pulsating forces clinically shown to stimulate cellular activity in orthodontic treatment and demonstrated to speed up bone remodeling. The prescription-only device speeds up treatment with braces or aligners by as much as 50 percent while reducing discomfort.

To receive the benefits of accelerated treatment with AcceleDent, it is important for patients to use the device daily for 20 minutes. Dr. Straty Righellis, a highly respected orthodontic lecturer and practitioner, says that he is excited about AcceleDent Optima because of its proven technology, sleeker design and ability to improve compliance through the new AcceleDent app.

"I offer AcceleDent because the science supporting acceleration using low-pulsatile forces, such as those employed by AcceleDent, has existed for 40 years," said Righellis, who practices at Righellis and Associates in Oakland, California. "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."

OrthoAccel representatives developed the AcceleDent App to help patients maintain compliance throughout their treatment. The app allows patients to track their usage, set reminder notifications and compare their progress to other AcceleDent patients across the world. Patients who maintain optimal daily usage of AcceleDent will earn awards on the app's Achievements Screen. This added motivation is similar to badges that users earn on popular fitness tracking apps.

Orthodontists, treatment coordinators and other practice staff will be able to view a customizable web portal that syncs real-time usage data for each of their AcceleDent patients. Access to this data enables the clinical team to compliment patients who are excelling with compliance and to encourage low-compliant patients.

The availability of this data will allow for more proactive case management, including more informed scheduling, and an overall increase in practice efficiency. Orthodontists such as Righellis appreciate how easily they can integrate this innovative AcceleDent technology into their practice without burdening operations. 

"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," said Righellis, who has treated more than 100 patients with AcceleDent.

In addition to receiving FDA clearance, AcceleDent Optima has also been cleared by Health Canada and has received the CE Mark that makes it commercially available in Europe. U.S. orthodontists interested in learning more about AcceleDent Optima can visit http://www.acceledent.com/ or the OrthoAccel sales representative locator to find a company representative near them or call (866) 866-4919, Option 1.

About OrthoAccel® Technologies, Inc.
OrthoAccel® Technologies, Inc. is a privately owned medical device company engaged in the creation, manufacturing, marketing and sales of innovative solutions that enhance dental care and orthodontic treatment.  Among the company's innovations is AcceleDent®, an FDA-cleared, Class II medical device that employs patented SoftPulse Technology® that is demonstrated to speed up bone remodeling.  These safe and gentle vibrations accelerate tooth movement by as much as 50 percent and reduce discomfort associated with treatment.  Leading orthodontists from around the world report increased mechanical efficiency with orthodontic appliances and improved predictability of clinical outcomes with AcceleDent.  OrthoAccel, the Leader in Accelerated Orthodontics, is ranked on Deloitte's 2016 Technology Fast 500 as one of the fastest growing companies in North America.  OrthoAccel is based in Houston, Texas and maintains a global presence through its EMEA office in Essen, Germany.  To learn more about OrthoAccel's focus on improving the journey to healthy, beautiful smiles, visit AcceleDent.com.

 

SOURCE OrthoAccel Technologies, Inc.


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