Innokas Medical’s quality and regulations specialist worked together with Athlos to handle the complex and burdensome process to manage, collect, and file the 510(k) submission to the FDA.
Athlos designed, developed, and manufactured DC-Air™, an intraoral x-ray imaging sensor. In July 2021, the sensor passed the FDA 510(k) clearance and is now legally permitted to be marketed in the US.
The DC-Air™ intraoral sensor is used to produce high-quality imaging in dental practices. Compared to its predecessors, it’s completely wireless. It uses Bluetooth to connect to a docking station, that sends the data to a computer.
According to Athlos’ CEO, Konstantinos Spartiotis, the team aimed for the US market from the beginning. Accessing the market required the product to go through the laborious 510(k) clearance process.
“Although we have world-class technical talents, there would have been no way we could have handled all the fine details, the amount of documentation, and technical files required to submit the 510(k),” explains Konstantinos. Konstantinos says that he was recommended to turn to the Innokas Medical team for help – it was the good reputation of Innokas that lead him to contact and choose the company.
Linda Kellberg, Specialist, Product and Process Compliance at Innokas Medical has worked for Athlos as an integral team member in the position of Quality Manager with priority in submitting the FDA 510(k).
“There was a lot of work, but we made it all happen in due time. It was really cool to be able to go through the whole FDA 510(k) process and gain the experience,” says Kellberg.
“For patients, the intraoral sensor is more comfortable, and from the work point of view, the workflow is smoother, and the image quality is better. No one has been able to make it real until we did it. We will have the first sales in the US within a matter of a couple of weeks,” Konstantinos adds proudly and states: “Innokas has been a really special partner for us.”
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Source: Innokas Medical