DC-Air™ is an intraoral x-ray imaging sensor designed, developed, and manufactured by a Finnish company Athlos. In July 2021, the sensor passed the FDA 510(k) clearance and is now legally permitted to be marketed in the US. Innokas Medical’s quality and regulations specialist worked together with the Athlos team to handle the complex and burdensome process to manage, collect, and file the 510(k) submission to the FDA.
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. The innovation is based on direct conversion technology, which produces images of unprecedented sharpness and makes the imaging workflow digital from the start.
“This is a true revolution. And I dare say, the first new thing in intraoral technologies in the last 30 years. I would compare this with when you moved from film to digital sensors”, says Athlos’ CEO Konstantinos Spartiotis.
According to Konstantinos, 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)”, Konstantinos explains. 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). “Linda has been a part of the Athlos management in the sense that she is our quality manager”, Konstantinos states and continues: “She is very efficient, and there haven’t been any doubts that she couldn’t represent Athlos as QM in front of anyone, including the FDA”.
“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”, Linda says.
“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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